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Background: The SMILES trial was the first randomized controlled trial (RCT) explicitly designed to evaluate a dietary intervention, conducted by qualified dietitians, for reducing depressive symptomatology in adults with clinical depression. Objectives: Here we detail the development of the prescribed diet (modified Mediterranean diet (ModiMedDiet)) for individuals with major depressive disorders (MDDs) that was designed specifically for the SMILES trial. We also present data demonstrating the extent to which this intervention achieved improvements in diet quality. Methods: The ModiMedDiet was designed using a combination of existing dietary guidelines and scientific evidence from the emerging field of nutritional psychiatric epidemiology. Sixty-seven community dwelling individuals (Melbourne, Australia) aged 18 years or over, with current poor quality diets, and MDDs were enrolled into the SMILES trial. A retention rate of 93.9 and 73.5% was observed for the dietary intervention and social support control group, respectively. The dietary intervention (ModiMedDiet) consisted of seven individual nutrition counselling sessions delivered by a qualified dietitian. The control condition comprised a social support protocol matched to the same visit schedule and length. Results: This manuscript details the first prescriptive individualized dietary intervention delivered by dietitians for adults with major depression. Significant improvements in dietary quality were observed among individuals randomized to the ModiMedDiet group. These dietary improvements were also found to be associated with changes in depressive symptoms. Discussion/Conclusion: The ModiMedDiet, a novel and individually tailored intervention designed specifically for adults with major depression, can be effectively implemented in clinical practice to manage this highly prevalent and debilitating condition. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered 29 February 2012
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Nutritional Neuroscience
An International Journal on Nutrition, Diet and Nervous System
ISSN: 1028-415X (Print) 1476-8305 (Online) Journal homepage:
A modified Mediterranean dietary intervention
for adults with major depression: Dietary protocol
and feasibility data from the SMILES trial
Rachelle S. Opie, Adrienne O'Neil, Felice N. Jacka, Josephine Pizzinga &
Catherine Itsiopoulos
To cite this article: Rachelle S. Opie, Adrienne O'Neil, Felice N. Jacka, Josephine Pizzinga &
Catherine Itsiopoulos (2017): A modified Mediterranean dietary intervention for adults with major
depression: Dietary protocol and feasibility data from the SMILES trial, Nutritional Neuroscience,
DOI: 10.1080/1028415X.2017.1312841
To link to this article:
© 2017 The Author(s). Published by Informa
UK Limited, trading as Taylor & Francis
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A modified Mediterranean dietary
intervention for adults with major depression:
Dietary protocol and feasibility data from the
SMILES trial
Rachelle S. Opie1, Adrienne ONeil2,3, Felice N. Jacka 2,4,5,6,
Josephine Pizzinga2, Catherine Itsiopoulos1
School of Allied Health, La Trobe University, Bundoora, VIC, Australia,
Food and Mood Centre, IMPACT SRC,
Deakin University, Geelong, VIC, Australia,
Melbourne School of Population and Global Health, The University
of Melbourne, Parkville, VIC, Australia,
Department of Psychiatry, University of Melbourne, Parkville, VIC,
Centre for Adolescent Health, Murdoch Childrens Research Institute, Parkville, VIC, Australia,
Dog Institute, Randwick, NSW, Australia
Background: The SMILES trial was the first randomized controlled trial (RCT) explicitly designed to evaluate a
dietary intervention, conducted by qualified dietitians, for reducing depressive symptomatology in adults with
clinical depression.
Objectives: Here we detail the development of the prescribed diet (modified Mediterranean diet
(ModiMedDiet)) for individuals with major depressive disorders (MDDs) that was designed specifically for
the SMILES trial. We also present data demonstrating the extent to which this intervention achieved
improvements in diet quality.
Methods: The ModiMedDiet was designed using a combination of existing dietary guidelines and scientific
evidence from the emerging field of nutritional psychiatric epidemiology. Sixty-seven community dwelling
individuals (Melbourne, Australia) aged 18 years or over, with current poor quality diets, and MDDs were
enrolled into the SMILES trial. A retention rate of 93.9 and 73.5% was observed for the dietary intervention
and social support control group, respectively. The dietary intervention (ModiMedDiet) consisted of seven
individual nutrition counselling sessions delivered by a qualified dietitian. The control condition comprised
a social support protocol matched to the same visit schedule and length.
Results: This manuscript details the first prescriptive individualized dietary intervention delivered by dietitians
for adults with major depression. Significant improvements in dietary quality were observed among
individuals randomized to the ModiMedDiet group. These dietary improvements were also found to be
associated with changes in depressive symptoms.
Discussion/Conclusion: The ModiMedDiet, a novel and individually tailored intervention designed
specifically for adults with major depression, can be effectively implemented in clinical practice to
manage this highly prevalent and debilitating condition.
Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820.
Registered 29 February 2012
Keywords: Depression, Modified Mediterranean diet, Dietary intervention, Randomized controlled trial, Dietitian
Depressive disorders are one of the leading causes of
disease burden globally.
In many Western countries
like Australia, one in five individuals aged 1685 years
have a mental disorder (anxiety, mood, or substance
use disorders), and almost half (45% or 7.3 million
people) have experienced a mental disorder at some
point in their lives.
While remarkable advances have
been made in the detection and management of
depressive disorders over the past decade,
the high
worldwide prevalence of depression in both developed
and developing countries
continues to pose chal-
lenges for individuals, families, clinicians, and
society. Hence, there is a need to investigate new
approaches to prevent and better manage depression.
Observational evidence supports the protective role
of a healthy dietary pattern, such as the Mediterranean
© 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
This is an Open Access article distributed under the terms of the Creative Commons Attri bution-NonCommercial-NoDerivatives License (http://c
licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not
altered, transformed, or built upon in any way.
DOI 10.1080/1028415X.2017.1312841 Nutritional Neuroscience 2017
Correspondence to: Rachelle S. Opie, School of Allied Health, La Trobe
University, VIC, Australia.
Downloaded by [La Trobe University] at 17:11 08 August 2017
diet (rich in fresh fruits, vegetables, fish, extra virgin
olive oil, and whole grains) on depression risk.
high intake of processed foods, consisting of swee-
tened desserts, fried food, processed meats, and
refined cereals, is associated with increased risk, sug-
gestive of deleterious effects.
However, the existing
data are largely drawn from observational studies,
which pose limitations in determining causality. This
is of particular concern when considering that the
relationship between depression and diet is bi-direc-
tional; individuals with depression are more likely to
consume poorer quality diets than those without.
For example, clinical depression and depressive symp-
toms are often associated with altered appetite, which
can involve either an increased appetite with cravings
or a reduced interest in food.
Negative mood
states can stimulate a preferential desire to consume
salty, sweet, or high-fat foods.
depression is also commonly associated with fatigue
and apathy,
which may have impact on an individ-
uals motivation to engage in healthy dietary
a reduced desire to cook,
and depleted
energy for activities such as grocery shopping and
meal preparation.
As a result of decreased concen-
tration, decreased mental endurance, and slowed
individuals may also find learning new
recipes, developing cooking skills, or performing
meal preparation challenging.
Finally, depression has a strong bidirectional
relationship with other common, chronic diseases with
a dietary aetiology, including heart disease, obesity,
and diabetes. These comorbidities can complicate treat-
ment approaches and have a detrimental impact on
treatment outcomes.
Thus, for a number of reasons,
dietary improvement in individuals with depression is
a potentially important therapeutic approach that is
likely to yield a range of health benefits.
The SMILES trial, Supporting the Modification of
lifestyle In Lowered Emotional States, was the first
randomized controlled trial (RCT) explicitly designed
to evaluate a dietary improvement intervention, con-
ducted by Accredited Practicing Dietitians, for redu-
cing depressive symptomatology.
At 3 months,
large between-group effect sizes of 1.16 were
observed in favour of the dietary intervention group.
Here we detail the development of the prescribed
diet intervention (the modified Mediterranean diet),
and the extent to which the diet is feasible and able
to achieve improvements in dietary quality.
Overview of the SMILES study
Detailed study methods of the SMILES trial have been
published previously.
Briefly, the SMILES trial was a
12-week, parallel group, single-blind, RCTof a dietary
intervention for the treatment of moderate-to-severe
depression. The study was conducted over two sites:
an inner city setting (Melbourne, Australia) and a
regional setting (Geelong, Australia). Participants
were randomized to receive either the dietary interven-
tion or a control condition (social support befriend-
). Recruitment and intervention delivery
occurred from October 2012 to July 2015.
Eligible participants were aged 18 years or over, suc-
cessfully fulfilled the Diagnostic and Statistical
Manual of Mental Disorders 4 (DSM-IV-TR) criteria
for major depressive disorder (MDD) Single Episode
or Recurrent, scored 18 or over on the Montgomery
Åsberg Depression Rating Scale (MADRS),
had current poor quality diets as determined by a
score of 75 or less (out of 104) in a Dietary
Screening Tool.
Broadly defined, participants had
to report a poor (low) intake of dietary fibre, lean pro-
teins, fruits and vegetables, and a high intake of sweets,
processed meats, and salty snacks.
Participants were
eligible if they were able to eat foods as prescribed,
without religious, medical, or socio-cultural factors
precluding participation or adherence to the pre-
scribed diet. If participants were on antidepressant
therapy or undergoing psychotherapy, they were
required to be on the same treatment for at least 2
weeks prior to randomization.
Intervention intensity
Diet intervention participants received seven individ-
ual face-to-face sessions (60 minutes each) held at
the study centre over a 3-month period. The first
three sessions occurred weekly and the remaining
four sessions occurred fortnightly. Assessments were
completed prior to programme commencement (base-
line), at programme completion (3 months), and at 6
months following baseline assessment. The control
condition (social support) used the same visit schedule
and length as the diet intervention in an individualized
Social support control group
The control condition (social support) comprised a
befriending protocol.
Befriending consisted of a
trained person (research assistant (RA)) discussing
neutral topics of interest to the participant with the
intention of keeping the participant engaged and posi-
tive, without employing techniques specifically used in
the major models of psychotherapy.
Individuals ran-
domized to the control group were not provided with
any dietary advice.
Dietary assessment tools
As part of the comprehensive dietetic consult, the die-
titian conducted a diet history to assess habitual
dietary intake at the first session (diet intervention
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017
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group only). This incorporated a checklist of com-
monly consumed foods to prompt and cross-check
accuracy of reporting. Food models and metric
measuring utensils were used to assist with the esti-
mation of portion sizes. Information on eating beha-
viours; dieting and weight history; motivators,
barriers, and ambivalence to change were also dis-
cussed. Additionally, participants in both groups
were asked to complete a 7-day food diary immedi-
ately prior to baseline assessment. Participants were
encouraged to record their intake at the time of con-
sumption to minimize error. With the participant
present, qualified dietitians (intervention group) or
trained RAs (control group) examined the food
diaries in detail to check for completeness and accu-
racy. Portion sizes were checked using food models
and household measures. The baseline diet history
and 7-day food diary were utilized in dietetic consults
(intervention group only) to help promote adherence
to the modified Mediterranean diet (ModiMedDiet).
The information on food and fluid intake from 7-day
food diaries was entered into FoodWorks7 (Ausnut
and analysed for nutrient content. Dietary sup-
plement usage was captured in a lifestyle questionnaire.
However, this information was not included in the
nutrient analysis. Therefore, findings are reflective of
food and beverage consumption exclusively. Of note,
at baseline and 3-month assessment, there were no
statistically significant differences between groups with
regard to nutritional supplement usage (P>0.05).
Under- and over-reporting were measured using the
Goldberg cut-off
to provide an indicator of the likely
validity of the food diary information. This approach
is a validated method that directly compares energy
intake (EI) with energy expenditure. Under- and
over-reporting were based on the relationship
between EI and Estimated Energy Requirements
(EER). EI was calculated based on reported intake
from 7-day food diaries, and the Schofield equations
were used to calculate EER. Under-reporters were
defined as EI:EER <0.76, acceptable reporters
defined as EI:EER 0.761.24, and over-reporters
defined as EI:EER >1.24.
Under- and over-repor-
ters were not excluded from the analysis, but their
impact on findings was explored.
The dietary intervention
The dietary intervention comprised personalized
dietary advice and nutrition counselling support,
including motivational interviewing, goal setting,
and mindful eating, from a qualified dietitian in
order to enhance dietary quality and achieve optimal
adherence to the recommended diet. This comprised
the ModiMedDiet, developed by Rachelle S. Opie
and Catherine Itsiopoulos, which is discussed in
detail below.
Intervention development
Core components
The Mediterranean diet is the most extensively
researched diet in the world. In 2014, Sofi et al.,
published a systematic review and meta-analysis of
cohort studies showing that high adherence to the
Mediterranean diet significantly reduced the risk of
overall mortality, cardiovascular incidence or mor-
tality, cancer incidence or mortality, and incidence of
neurodegenerative diseases. Drawing on this, as well
as the meta-analysis demonstrating a reduced risk for
depression for those with higher adherence to a
Mediterranean diet,
and evidence from the emerging
field of nutritional psychiatry,
we created a modi-
fiedMediterranean diet (ModiMedDiet) for the
needs of our patient population.
The ModiMedDiet was primarily constructed using
the Dietary Guidelines for Adults in Greece
the Mediterranean-type diet principles from the
Additionally, the Australian
Dietary Guidelines
were utilized for relevance in a
non-Mediterranean population and for application
to the Australian context. These additional foods
(e.g. breakfast cereals, whole grain biscuits, and
game meats such as kangaroo) are commonly con-
sumed in Australia, and were grouped into relevant
categories based on their similar macro- and micro-
nutrient compositions. Moreover, Australian
Governments endorsed guidelines relevant to cardio-
vascular disease health were used due to the strong
overlap between depression and cardio-metabolic con-
Finally, publications by Itsiopoulos
et al.,
and Kouris-Blazos et al.,
were utilized
to ensure that the diet closely resembled the nutrient
profile of the traditional Mediterranean diet.
Like the traditional Mediterranean diet,
ModiMedDiet was designed to be rich in vegetables,
fruits, and wholegrain cereals with an emphasis on
increased consumption of oily fish, legumes, raw-
unsalted nuts and seeds, and extra virgin olive oil (as
the main source of added fat). A moderate consump-
tion of reduced fat natural dairy products was rec-
ommended to limit saturated fat intake in an effort
to achieve the nutrient profile of a traditional
Mediterranean diet. The diet was also modified to
include a moderate consumption of lean red meat.
This recommendation was based on epidemiologic evi-
dence from nutritional psychiatry showing that women
consuming less (or more) than the recommended
intake of red meat were more likely to have clinical
depressive and/or anxiety disorders, than those con-
suming the recommended amount.
Moreover, red
meat is a rich source of iron, zinc, and vitamin B12,
which are believed to play a potentially protective
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017 3
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role in common mental disorders.
Promoting ade-
quate lean red meat intake is of further relevance
when considering that 38% of Australian women
aged 1950 years have inadequate intakes of iron.
Figure 1and Table 1display the 12 food groups, and
their corresponding serving sizes, that comprise the
ModiMedDiet. Individuals were advised to consume
the diet ad libitum (e.g. participants were encouraged
to eat according to appetite), as the diet intervention
did not have a weight loss focus. The ModiMedDiet
provided 11 MJ of daily energy, and was high in fat
(40% of energy; >50% from monounsaturated fats),
low to moderate in carbohydrate (36% of energy), mod-
erate in protein (18% of energy), and moderate in
alcohol (2% of energy from red wine). Based on the
nutrient analysis for complete dietary adherence,
ModiMedDiet was high in fibre (50 g/d), folate
(709 μg/d), and vitamin C (247 mg/d) consistent with
large quantities of fruits (411 g/d) and vegetables
(709 g/d). Importantly, the ModiMedDiet met all
Recommended Dietary Intakes (RDI) or Adequate
Intake (AI) requirements for adult males and
with the exception of Vitamin D (Table 2).
Resources and nutrition topics
Participants were provided with a ModiMedDiet
resource kit, which included supporting written infor-
mation designed especially for the intervention in
order to enhance dietary compliance. This resource
kit included ModiMedDiet dietary guidelines, con-
venient meal ideas, healthy snack options, shopping
lists, and meal plans. The semi-quantitative
ModiMedDiet food pyramid (Fig. 1) was developed
using relevant literature from the field of Nutritional
Psychiatric Epidemiology, the National Dietary
Guidelines and published Mediterranean diet
and was designed as a simplified and prac-
tical visual to assist participants in implementing the
dietary intervention.
The material provided was intended to stimulate
informed discussions about relevant nutritional
topics between the participant and the dietitian.
Refer to Supplementary Material for an example of
the ModiMedDiet resource kit. Participants were
encouraged to set personalized goals at each session
and identify barriers/motivators to change. Where rel-
evant, follow-up sessions incorporated themes to
support behavioural change, such as label reading,
recipe modification, time-management, and food
security (access to healthy food and tips for budget
buying). At the final session, goals achieved during
the intervention period were discussed and summar-
ized, with longer-term strategies developed to
support sustainable change. Refer to Table 3for an
outline of the session content.
As enjoyment and palatability of meals is extremely
important for enhancing dietary compliance, menus,
recipes, and food hampers with the key components
of the intervention diet were developed and dissemi-
nated to participants. Despite the complexities and
detailed science underpinning the development of the
diet, the ModiMedDiet intervention was designed to
be easy-to-follow, sustainable, practical, and consider-
ate of individual circumstances. Full dietary adherence
was considered unrealistic.
Instead, the primary
focus was on achieving positive behaviour change
and improving dietary quality through displacement
of discretionary itemswith healthy nutrient-dense
foods. A healthy relationship with all foods was
encouraged, and no foods were prohibited. By catering
to individual taste preferences and the potential for
appetite change, participants were more likely to be
receptive to dietary advice. For example, healthy fats
(e.g. olive oil and nuts), natural sugars (e.g. honey
and fresh fruit), and salty foods (e.g. olives and Feta
cheese), consistent with a traditional Mediterranean
diet, were encouraged to help tackle common cravings.
Nutritional counselling component
Similar to the PREDIMED trial,
the ModiMedDiet
intervention was undertaken in free-living persons;
they received information, motivation, support, and
empowerment from qualified dietitians with specialized
nutritional counselling skills in order to modify their
food habits in a real-life context, i.e. they continued to
buy their own foods and cook their own meals. A
study protocol manual was developed prior to trial
commencement for use by the study dietitians
Figure 1 ModiMedDiet food pyramid.
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017
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Table 1 ModiMedDiet food group components and example serving sizes
Food group One serve equals Number of servings Other food examples
1. Wholegrains 58 per day
Tips: choose wholegrain or
wholemeal varieties
Breakfast cereals: fibre >7.5 g per
100 g and sugar <15 g per 100 g
(<25 g per 100 g products with
dried fruit)
Biscuits: fibre >7.5 g per 100 g and
salt <400 mg per 100 g
1 slice bread
2cup cooked rice /
pasta (5060 g)
2cup cooked other
grains (5060 g)
4cup oats or muesli
(30 g)
2/3 cup breakfast
cereal flakes (30 g)
2 Weet-Bix
3 crisp breads
Fibre Plus, All-bran, Weet-Bix,
Porridge, Oats
Wholemeal bread or pita, wholegrain
bread, sourdough bread, wholemeal
English muffin, Artisan fruit toast
White flour pasta, quinoa, barley
Vita-weat biscuit, Ryvita multi-grain
biscuit, Real Foods corn thins, air-
popped popcorn
Nutri-grain, Corn-Flakes, instant noodles,
white bread, raisin bread, rice
crackers, rice cakes, highly processed
white rice (e.g. jasmine rice, Arborio
rice), gnocchi, Salada, Cruskits, water-
2. Vegetables 6 per day
2cup cooked
(75100 g)
1 cup leafy greens
(75100 g)
1 tomato
1 small potato
(75100 g)
Starchy vegetables
(75100 g)
Include tomatoes and
leafy greens daily
Maximum 1 potato per
3. Fruit 3 per day
Tips: select fresh fruit preferentially 1 medium-sized fresh
fruit (150 g)
2 smaller sized fresh
fruit (150 g)
1 cup tinned fruit
(150 g)
2tablespoons dried
fruit (30 g)
Limit fruit juice to 1
per day (125 mL)
4. Dairy 23 per day
Tips: select reduced fat products
and natural (or Greek) yoghurt
1 cup milk (250 mL)
200 g yoghurt
40 g hard cheese
40 g feta cheese
120 g ricotta cheese
All dairy products.
All calcium fortified soy products.
5. Nuts 1 per day
Tips: select raw and unsalted nuts
preferably walnuts and almonds
30 g nuts
30 g seeds
30 g nut spread (e.g.
peanut butter)
80 g olives
LSA, pumpkin seeds, sunflower seeds,
6. Legumes and Pulses 34 per week
Tips: select dried or canned legumes
(e.g. chickpeas, lentils, baked
beans, kidney beans)
2cup legumes
(75100 g)
75 g hummus
100 g tofu
7. Lean Red Meat 34 per week
Tips: select lean meat and remove
the fat
65100 g lean red meat
2cup mince
2 small chops
lean beef, lean pork, lean ham
8. Fish At least 2 per week
Tips: preferentially select oily fish e.g.
salmon, tuna, and sardines
100 g cooked
1 small can (95 g)
Salmon 12 times per
week (or other fish
high in LC omega-3
All fish e.g. white and oily fish.
Tinned, fresh, or frozen fish.
Smoked salmon, sardines, scallops,
prawns, oysters, squid.
9. Poultry 23 per week
Tips: remove the skin 80100 g poultry Includes:
Chicken, turkey, duck
10. Eggs Up to 6 eggs per week
1 egg (60 g)
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017 5
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(Rachelle S. Opie, intervention site # 1; Josephine
Pizzinga, intervention site # 2) to ensure that a standar-
dized dietary intervention was delivered. This protocol
manual incorporated the main elements of the dietary
intervention with details regarding session outline
and content, delivery and dissemination of the
ModiMedDiet resource kit, nutritional counselling
techniques, troubleshooting, data collection, and
With insight into the common characteristics of
depression, and with awareness of the typical barriers
to healthy eating faced by individuals with depressive
disorders, information provision in isolation was seen
as insufficient for promoting and maintaining dietary
improvement. Hence, the ModiMedDiet intervention
was designed as a behaviour change intervention, with
a substantial nutritional counselling component that
incorporated motivational interviewing,
and mindful eating, and goal setting. Every
effort was made to avoid a purely prescriptive approach.
The dietary intervention was exclusively delivered by
Accredited Practising Dietitians (Rachelle S. Opie and
Josephine Pizzinga) who possessed the necessary
skills, training, knowledge, educational resources, and
experience to support and facilitate behaviour change.
Moreover, the dietitians were able to translate the intri-
cate science underpinning the ModiMedDiet com-
ponents into simple, clear, relevant, and
individualized advice. These skills are consistent with
the Role Statement for Accredited Practicing
Dietitians practising in the area of Mental Health.
Findings from a systematic review
provide evi-
dence that, in addition to the beneficial role of a
healthy diet, the delivery mode and interventionist
(individual delivering the intervention) are likely
crucial components to success of a dietary interven-
tion. Subsequently, essential features for successful
delivery of the ModiMedDiet intervention required
the dietitian to provide patient-centred care, be
respectful, and instil confidence so that the patient
felt empowered and capable of taking control of
their diet and other aspects of their life. Rapport build-
ing was imperative. Through developing good rapport,
dietitians provided safe, comfortable, and relaxing
conducive to the development of a
trusting relationship.
The dietitian listened carefully
to their patient without assumptions, bias or passing
judgement and recognized the patient as the expert
when it comes to information about his or her experi-
This allowed the dietitian to understand the
patients needs and concerns. Collaboration between
the dietitian and patient was essential, and flexibility
allowed the dietitian to tailor individual sessions to
the patients needs and interests. Dietary recommen-
dations were considerate of individual lifestyle and
social circumstances, while being culturally sensitive
and amenable to potential fluctuations in mood state
and motivation levels.
To encourage dietary adherence consistent with the
strategies used by the PREDIMED study,
display the variety of foods that form the diet, partici-
pants were provided with a food hamper at the com-
pletion of the initial consult, which contained the
main components of the ModiMedDiet. A combi-
nation of fresh produce (e.g. tomatoes and lean red
meat) and non-perishables (e.g. frozen berries and
tinned baked beans) were included in the hamper in
consideration of individuals with limited storage and
cooking facilities. In an effort to support individuals
with limited cooking skills/knowledge, and to assist
with the incorporation of potentially unfamiliar or
rarely utilized foods, recipes and meal plans using
foods provided in the hamper were available to partici-
pants (Refer to Supplementary Material for details of
the food hamper contents and meal plan). A second
hamper was provided for attendance at the final
session, to obtain final outcome measurements, and
for trial completion. Moreover, it was designed to
promote continued dietary adherence after interven-
tion cessation.
Table 1 Continued
Food group One serve equals Number of servings Other food examples
11. Olive Oil 60 mL (3TB) per day
Tips: select extra virgin olive oil 1TB olive oil (20 mL)
1.5TB olive oil spread/
margarine (30 g)
Use daily as the main
added fat
12. Extras 3 per week
1 extra
portion =120 kcal
(500 kJ)
Sweets, highly processed cereals, chips
and savoury pastries, fried food, fast-
food, fatty meat, processed meats, dairy
desserts, sugary drinks, condiments
Tips: select red wine preferably and
only drink with meals
1 standard
drink =100 mL wine
(10 g ethanol)
No more than two
standard drinks per
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Table 2 Nutrient analysis of the ModiMedDiet based on six servings of wholegrain cereals, and compared to the reference diets
and the NHMRC NRVs
avg /day
Reference diets NRVs
National Health and Medical
Research Council (NHMRC)
et al.
et al.
Weight (g) 2372 ——
Energy (kcal (kJ)) 2596 (10 863) 2629 (11 000) ——
Protein (g) 113.05 RDI: 64 g/d()
RDI: 46 g/d()
Total fat (g) 116.31 ——
Saturated fat (g) 26.42 ——
Polyunsaturated fat (g) 23.82 ——
Monounsaturated fat (g) 58.42 ——
Cholesterol (mg) 237.49 ——
Carbohydrate (g) 238.13 ——
Sugars (g) 106.38 ——
Starch (g) 129.90 ——
Water (g) 1813.43 ——
Alcohol (g) 6.34 ——
Dietary fibre (g) 49.88 47 AI: 30 g/d()
AI: 25 g/d()
Thiamin (mg) 1.57 ——RDI: 1.2 mg/d()
RDI: 1.1 mg/d()
Riboflavin (mg) 3.09 ——RDI: 1.3 mg/d()
RDI: 1.1 mg/d()
Niacin equivalents (mg) 41.84 ——RDI: 16 mg/d()
RDI: 14 mg/d()
Vitamin C (mg) 247.52 274 RDI: 45 mg/d(♂♀)
Vitamin D (µg) 4.38 ——AI: 5 ug/d(♂♀ 1950)
AI: 10 ug/d(♂♀ 5170)
Vitamin E (mg) 23.04 ——AI: 10 mg/d()
AI: 7 mg/d()
Total folate (µg) 707.41 700 ——
Folic acid (µg) 1.98 ——
Folate food (µg) 705.43 ——
Folate, total DFE (µg) 708.74 ——RDI: 400 ug/d(♂♀)
Total vitamin A (µg) equivalents
2190.73 ——RDI: 900 ug/d()
RDI: 700 ug/d()
Retinol (µg) 321.32 ——
Beta carotene equivalents (µg) 11208.60 ——
Sodium (mg) 1512.62 ——AI: 460920 mg/d(♂♀)
|UL: 2300 mg/d
Potassium (mg) 5724.23 ——AI: 3800 ()
|AI: 2800 ()
Magnesium (mg) 608.08 ——RDI: 420 mg/d()
RDI: 320 mg/d()
Calcium (mg) 1742.93 ——|RDI: 1000 mg/d(♂♀ 1950)
|RDI: 1000 mg/d(5170) |RDI:
1300 mg/d(5170)
Phosphorus (mg) 2284.87 ——|RDI: 1000 mg/d(♂♀)
Iron (mg) 18.00 ——RDI: 8 mg/d()
RDI: 18 mg/d(1950)
RDI: 8 mg/d(5170)
Zinc (mg) 15.79 ——RDI: 14 mg/d()
RDI: 8 mg/d()
Iodine (µg) 159.37 ——RDI: 150 ug/d(♂♀)
kcal from protein 17.69% of E 12% of E <15% of E 1525% of E
kcal from fat 39.62% of E 40% of E 4045% of E 2035% of E
kcal from saturated fat 9.00% of E 1012% of E
kcal from carbohydrate 36.00% of E 44% of E 3844% of E
(28% complex)
4565% of E
kcal from sugar 16.35% of E 12% refined of
kcal from alcohol 1.69% 4% of E from red
<5% of E
kcal from mono 20.27% of E
(53.77% of total
>50% of total fat 2022% of E
kcal from poly 8.27% of E <5% of E
Long Chain N3 (mg) 694.96 ——AI: 160 mg/d()
AI: 90 mg/d()
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Table 2 Continued
avg /day
Reference diets NRVs
National Health and Medical
Research Council (NHMRC)
et al.
et al.
F18D2N6 (g) 19.13 ——AI: 13 g/d()
AI: 8 g/d()
F18D3N3 (g) 3.74 ——AI: 1.3 g/d()
AI: 0.8 g/d()
Caffeine (mg) 2.93 ——
Fruits (g/day) 411 563 ——
Vegetables (g/day) 709 691 ——
Olive oil (ml/day) 60 75 60
Please note: allowing for intestinal absorption and for the nitrogenous parts of protein that cannot be completely oxidized, the
average amount of energy released ranges from approximately 3.99 kcal/g (16.7 kJ/g) for carbohydrates or protein, 9.01 kcal/g
(37.7 kJ/g) for fats, and 7.00 kcal/g (29.3 kJ/g) for alcohol.
Table 3 ModiMedDiet session details
Session #
resources Comments
1Introduce the Dietitian and the intervention purpose,
scope, and structure.
Assess current eating practices (complete NCP Diet
oIdentify habitual behaviours, dieting and weight
history, motivators, barriers, and ambivalence to
Assess social (e.g. family dynamics and support),
environmental (e.g. food security issues, cooking
facilities), physical (e.g. exercise, cooking skills, and
nutrition knowledge) and medical background (e.g.
mental health status, health care utilization,
medication, and clinical history).
Present and discuss the ModiMedDiet Food Pyramid,
ModiMedDiet Example Serving Sizes, ModiMedDiet
Top 10 Tips.
Facilitate goal setting (complete SMART Goals)
oAssess confidence to change (complete Assessing
Confidence Scale). Encourage modification of goals
with a confidence score of 8 or less.
Provision of food hamper (home delivered)
oDisplay the main foods provided (ModiMedDiet Food
Hamper Contents).
Session 1 is primarily focussed on educating the
participant on the specific dietary components that
comprise the ModiMedDiet. However, the dietitian
must deliver this session with the knowledge that
information provision in isolation does not achieve
behaviour change.
Dietary advice should be provided in a manner that
reinforces the positive aspects of the participants
habitual eating patterns while drawing attention to
areas for improvement, without being discouraging
and without judgement.
Make every effort to avoid overwhelming the participant.
The dietitian must be highly aware of the participants
verbal and non-verbal cues when setting goals and
when determining the ideal number of goals to set.
Success is most likely achieved when dietary changes
are compatible with, and considerate of, individual
lifestyle circumstances.
Where appropriate and if time permits, provide ideas and
practical strategies for incorporating the foods
included in the hamper.
26Review goals from previous week.
Revisit areas of particular interest or concern, or
challenges faced. Facilitate discussion and problem-
Facilitate goal setting (complete SMART Goals).
oAssess whether previous goals need to be adjusted,
and set new goals where appropriate.
Present and discuss any of the following topics or
resource material where appropriate that reflects the
participantsinterests or concerns:
oThe Healthy Eating Plate, Convenient Meal Ideas,
Example Meal Plan, Daily or Weekly Checklist,
Shopping List, ModiMedDiet Recipes, Recipe
Modification, Healthy Snack Ideas, Label Reading,
Dining Out and Take-Away Foods, Mindfulness and
Mindful Eating, Tips for Budget Buying
Revisit the ModiMedDietTop 10 Tips at each session
to highlight and reiterate the primary dietary
Support the participant in focussing their attention to
healthy, positive behaviour changes. Do not dwell on
the unhealthy food choices. Instead, provide practical
and individualized strategies for consuming more
healthy nutrient-dense foods, which typically leads to
the subsequent displacement of discretionary items.
7Review goals from previous week.
Explore and affirm healthy behaviours achieved from
this intervention.
Discuss long-term goals for achieving sustainable
dietary change.
Provision of food hamper.
Reinforce the positive behaviour changes that have
occurred over the intervention period to empower the
individual and motivate them to continue with the
desired dietary changes long term.
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Assessment of diet quality
The ModiMedDiet score was specifically constructed
for use in the SMILES trial by Rachelle S. Opie as a
surrogate measure of diet quality, where higher
scores were indicative of a better quality diet. The
score allowed for measurement of adherence and com-
pliance to the ModiMedDiet among dietary interven-
tion participants, and was also calculated for the
control group to capture any dietary changes that
may have occurred as a result of being involved in
the study. In brief, the ModiMedDiet score is similar
to the adherence scores used in PREDIMED
the Framingham Offspring Cohort
a criterion-
based diet score, which uses pre-defined absolute or
normative goals of consumption for specific food
items, independent of the individuals characteristics.
Specifically, it was developed based on the rec-
ommended intakes of the 12 food group components
that comprise the ModiMedDiet (Table 1), and is
out of a theoretical maximum value of 120. Refer to
Supplementary Material for details of the
ModiMedDiet score. For reference, lowest adherence
to the ModiMedDiet was defined as a score of
33.65 (Quartile 1), whereas highest adherence to
the ModiMedDiet was defined as a score of 55.62
(Quartile 4).
Extras were included in the ModiMedDiet score as
a dichotomous variable, as well as being reported on
as a measure of diet quality independently. A lower
percentage EI from extras (e.g. sweets, highly pro-
cessed cereals, crisps, fast-food, sugary drinks) was
suggestive of a healthier diet. These foods are con-
sidered unhealthy due to their high saturated fat,
high salt and/or high sugar content. Refer to Table
S1 for a description of foods classified as extras. The
percentage EI from extras was calculated by
summing the total number of kilocalories (kcal)/kilo-
joules (kJ) consumed as extras per day, and dividing
this figure by the participants average total EI. This
information was obtained from FoodWorks7,
based on the 7-day food diary data.
Statistical analysis
Descriptive statistics were completed first and data
were checked for normality using Kolmogorov
Smirnov statistic. Continuous parametric data were
expressed as mean ±SD, whereas non-parametric
variables were presented as median ±IQR.
Categorical variables were expressed as frequencies
and percentages. The level of statistical significance
was set at P<0.05. All statistical analyses were per-
formed using the SPSS program, version 20.
independent samples t-test was used to compare the
mean scores between groups of normally distributed
continuous variables, whereas the MannWhitney U-
test was employed as the non-parametric alternative.
Paired samples t-test was used to compare the mean
scores for the groups at different time points; baseline
and 3-month assessment. The Wilcoxon signed-rank
test was used as the non-parametric alternative. A
one-way between-groups analysis of variance was
used to compare the mean scores of the dependent
variable across the four groups (quartiles of
ModiMedDiet score). KruskalWallis test was used
as the non-parametric alternative.
Between October 2012 and July 2015, 67 individuals
met all inclusion criteria and were enrolled into the
SMILES trial (dietary intervention, n=33; control,
n=34). Of these participants, four failed to submit
food diaries at the baseline assessment, and a further
17 final food diaries were missing as these participants
failed to complete the diary or did not attend the 3-
month assessment. Hence, dietary information was
available for 63 participants at baseline (dietary inter-
vention, n=33; control group, n=30) and 50 partici-
pants at the final assessment (dietary intervention, n=
26; control group, n=24).
At 3 months, the trial experienced a retention rate of
93.9% (n=31) and 73.5% (n=25) for the dietary
intervention and control group, respectively. The 11
individuals who dropped-out of the study became
uncontactable throughout the intervention period.
When comparing baseline MADRS, ModiMedDiet
score, anthropometric and demographic variables
between completers(n=56) and drop-outs(n=
11), no statistically significant differences were
observed. Furthermore, participants allocated to the
dietary intervention group attended significantly
more sessions than those randomized to the control
group (median 7 (IQR 2) versus 5 (6), respectively
(P<0.01)). However, session attendance did not sig-
nificantly differ across quartiles of adherence to the
ModiMedDiet (P>0.05NS).
Key characteristics of sample
At baseline, there were significantly more females in
the diet group than in the control group (P<0.05).
Otherwise, groups were well matched on demographic
characteristics. The mean age was 40 years (range 18
67 years), and approximately half of the individuals
had a comorbid disease such as hyperthyroidism,
hypertension, high cholesterol, diabetes, or arthritis.
Anthropometric measures
There were no statistically significant differences in
baseline anthropometric measures for the dietary
intervention and the control group (P>0.05 NS).
The majority (75.8%, n=50) of individuals were over-
weight or obese. On average, females had a waist
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
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circumference greater than 80 cm, and males had a
waist circumference greater than 94 cm, which is
indicative of an increased risk of chronic disease.
Average daily EI was 1957 kcal (8186 kJ) and
2355 kcal (9855 kJ) for females and males, respect-
ively. Seventy-five percent of participants were con-
sidered to be acceptablereporters, while 15 and
10% were under- and over-reporters, respectively.
At final assessment, no significant differences in
anthropometric measures between the dietary interven-
tion and control group were observed. Additionally,
there were no significant changes over the intervention
period for either group.
Diet quality
ModiMedDiet score
Despite randomized group allocation, at baseline the
ModiMedDiet score was significantly lower in the
dietary intervention than in the control group (36.18
versus 47.28, respectively; mean difference 11.09,
P<0.01). Similarly, the percentage energy from
extras was significantly worse (higher) in the dietary
intervention than in the control group (41.73 versus
31.69, respectively (P<0.05)). These differences are
primarily due to lower intakes of fruit and higher
intakes of extras in the dietary intervention group at
baseline (see below).
By the end of the intervention period, the diet group
tended to be more compliant with the ModiMedDiet
guidelines compared to those in the control condition
(ModiMedDiet score of 54.37 (SD 15.89) and 45.41
(16.03) for the diet and control group, respectively (P
>0.05 NS)). The effect size for this difference was a
Cohensdof 0.56. More specifically, individuals in
the diet group had improved their ModiMedDiet
score by an average of 19.88 points (mean 88.0%
score increase), and the percentage of energy from
extras had declined by a mean of 17.47 points.
Conversely, on average, the ModiMedDiet score and
the percentage of energy from extras had not improved
in the control group a mean change in
ModiMedDiet score of 1.87 points, and a mean
increase in extras of 1.26 points.
ModiMedDiet food group components
At baseline, there were no significant differences in
intake between the dietary intervention and control
group for the ModiMedDiet food group components,
with the exception of fruit and extras (Table 4). By
final assessment, the diet group were consuming sig-
nificantly more olive oil (P<0.001) than the social
support control group, and there was a trend for a
higher intake of vegetables and whole grain cereals
(Table 4).
At intervention cessation, the diet group were shown
to have significant improvements in the consumption
of the following food groups from baseline; whole-
grain cereals (mean increase 1.21 (SD 1.77) servings/
day, P<0.01), fruit (0.46 (0.71) servings/day, P<
0.01), dairy (0.52 (0.72) servings/day, P<0.001),
olive oil (0.42 (0.49) servings/day, P<0.001), pulses
(1.40 (2.39) servings/week, P<0.01), and fish (1.12
(2.65) servings/week, P<0.05) (Table 4). Moreover,
the magnitude of dietary changes observed in this
trial for whole grain cereals, vegetables, dairy, pulses,
and fish was greater than those seen in the seminal
Hence, implementation of the
ModiMedDiet is considered to be of high acceptability
and feasibility in a non-Mediterranean population.
With respect to the consumption of unhealthy food
items, intake of extras substantially declined in the
diet group (a mean decrease of 21.76 serves per week
(P<0.001)). Conversely, there were no significant
improvements from baseline observed in the social
support control group for all 12 ModiMedDiet food
group components (Table 4).
Nutrient intake
By final assessment, the dietary intake of protein (as a
% of EI), polyunsaturated fat (as a % of EI), dietary
fibre, vitamin E, long chain (LC) omega-3 PUFAs,
and α-linolenic acid had all significantly increased
among the diet group (Table 5). This is consistent
with improvements in intake of food groups associated
with the ModiMedDiet (as noted above). Additionally,
carbohydrate intake had significantly decreased by a
mean value of 29.6 grams, and as a percentage of
total energy (from 44.1 to 40.7%). Conversely, diet
quality as measured by nutrient density deteriorated
in the control group. Specifically, the intake of energy,
thiamin, vitamin E, ß carotene equivalents, potassium,
iron, and α-linolenic acid all statistically significantly
declined from baseline to final assessment in the
control condition (Table 5).
This paper describes in detail the ModiMedDiet inter-
vention, which is, to our knowledge, the first prescrip-
tive, individualized dietary intervention specifically
designed for adults with major depression. The infor-
mation provided in this manuscript provides a toolkit
for dietitians, and is designed to aid dietitians and
researchers in the delivery of the ModiMedDiet to
individuals with depression, in order to achieve
improvements in diet quality and depressive symptoms
as observed in our trial.
Specifically, the results of this study demonstrate
that with nutrition counselling support from a quali-
fied dietitian, improvements in dietary quality can be
achieved in a population with MDD. The diet group
were observed to be more compliant with the
ModiMedDiet guidelines, which were designed
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Table 4 ModiMedDiet food group components at baseline and 3-month assessment
food group component Time point
Diet group
mean (SD)
n=33 baseline
n=26 final
Control group
mean (SD)
n=30 baseline
n=24 final
Diet Control
Mean Change Mean Change
Wholegrain cereals Baseline 2.08 (1.51) 1.21 (1.77) 2.74 (1.61) 0.42 (1.34) 0.098
(1.68, 61)
(3.47, 25)
0.138 (1.54, 23)
Final 3.24 (1.64) 2.37 (1.81) 0.081
(1.79, 48)
Vegetables Baseline 1.73 (0.89) 0.53 (1.25) 1.91 (1.28) 0.14 (1.16) 0.495
(0.69, 61)
0.058 0.577
2.05 (1.63) 1.53 (1.08) 0.062
Fruit Baseline
0.60 (0.75) 0.46 (0.71) 1.00 (1.51) 0.05 (0.80) 0.035 0.004 0.989
Final 1.10 (0.80) 1.26 (0.88) 0.489
(0.70, 48)
Dairy Baseline 1.19 (0.84) 0.52 (0.72) 1.57 (0.95) 0.15 (0.82) 0.099
(1.68, 61)
(3.70, 25)
(0.88, 23)
Final 1.59 (0.74) 1.36 (0.79) 0.309 (1.03, 48)
Nuts Baseline
0.00 (0.60) 0.13 (0.56) 0.17 (0.63) 0.13 (0.83) 0.187 0.256 0.673
0.44 (0.65) 0.16 (0.71) 0.440
Olive Oil Baseline
0.00 (0.20) 0.42 (0.49) 0.00 (0.25) 0.10 (0.24) 0.750 0.000 0.037
0.25 (0.76) 0.00 (0.08) 0.000
Serves /Week
Pulses Baseline
0.00 (0.60) 1.40 (2.39) 0.12 (4.55) 0.70 (3.57) 0.107 0.008 0.300
0.18 (2.97) 0.00 (2.33) 0.198
Red Meat Baseline
3.06 (3.77) 0.26 (3.06) 3.21 (4.61) 0.38 (3.33) 0.572 0.681 0.693
Final 2.82 (1.77) 2.50 (2.35) 0.587 (0.55, 48)
Fish Baseline
0.44 (1.80) 1.12 (2.65) 1.38 (2.50) 0.23 (2.16) 0.121 0.042 0.852
1.00 (3.04) 1.10 (2.95) 0.896
Chicken Baseline
3.00 (5.23) 0.14 (4.26) 1.94 (2.99) 0.01 (3.34) 0.104 0.757 0.853
2.38 (3.08) 2.00 (2.63) 0.565
Eggs Baseline
1.00 (2.00) 0.40 (1.83) 1.88 (3.13) 0.12 (2.19) 0.077 0.297 0.722
2.00 (3.00) 1.08 (4.00) 0.984
Extras Baseline
49.62 (38.64) 21.76 (16.01) 39.44 (33.85) 1.36 (16.63) 0.052 0.000 0.786
20.45 (34.66) 35.66 (36.03) 0.361
Bold values indicate a statistically significant finding (p<0.05).
Non-parametric data presented as median (IQR).
P-values (t, df) for independent samples t-test (or MannWhitney U-test for non-parametric data).
P-values (t, df) for paired samples t-test (or Wilcoxon signed-rank test for non-parametric data).
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017 11
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Table 5 Macro- and micro-nutrient intake at baseline and final assessment
Nutrient Time point
Diet group
(n=33 baseline;
n=26 final)
Control group
(n=29 baseline;
n=24 final)
Mean (SD) Diet Control
Average Energy (kcal) Baseline 2061 (632) 2057 (438) 0.980
(0.03, 60)
(0.94, 25)
(2.45, 22)
Final 1971 (491) 1878 (423) 0.478
(0.72, 48)
Protein (% of E) Baseline 17.46 (3.05) 17.70 (2.96) 0.754
(0.32, 60)
(2.83, 25)
(0.41, 22)
Final 18.15 (3.09) 16.98 (3.18) 0.193
(1.32, 48)
Total fat (% of E) Baseline 35.27 (5.64) 34.44 (5.43) 0.558
(0.59, 60)
(1.28, 25)
(0.86, 22)
Final 37.20 (6.34) 34.98 (7.01) 0.245
(1.18, 48)
Sat Fat (% of E) Baseline 14.47 (3.54) 13.53 (2.88) 0.258
(1.14, 60)
(0.68, 25)
(1.32, 22)
Final 14.21 (3.58) 14.40 (3.73) 0.858
(0.18, 48)
Poly fat (% of E) Baseline 5.01 (1.68) 5.46 (1.73) 0.304
(1.04, 60)
0.017 0.951
5.72 (3.04) 5.29 (1.15) 0.290
Mono fat (% of E) Baseline 13.14 (2.56) 12.64 (2.58) 0.445
(0.77, 60)
0.091 0.858
14.15 (4.35) 11.68 (2.73) 0.015
Mono fat (% of Fat) Baseline 37.33 (4.52) 36.73 (4.44) 0.600
(0.53, 60)
(1.22, 25)
(1.17, 22)
Final 38.40 (5.26) 34.80 (4.60) 0.013
(2.57, 48)
Carbohydrate (% of E) Baseline 44.10 (6.42) 44.63 (6.62) 0.749
(0.32, 60)
(3.34, 25)
(0.52, 22)
Final 40.70 (6.04) 45.10 (8.01) 0.033
(2.20, 48)
Sugars (% of E) Baseline 20.02 (5.27) 20.57 (5.59) 0.688
(0.40, 60)
(1.45, 25)
(0.39, 22)
Final 17.96 (5.47) 21.82 (6.77) 0.031
(2.23, 48)
Dietary fibre (g) Baseline 21.33 (6.27) 24.91 (9.02) 0.072
(1.83, 60)
0.025 0.074
24.39 (9.19) 19.98 (9.58) 0.236
Thiamin (mg) Baseline
1.57 (1.02) 1.71 (1.01) 0.516 0.780 0.028
1.60 (0.91) 1.36 (1.07) 0.472
Niacin equiv. (mg) Baseline
45.63 (15.11) 45.75 (17.78) 0.657 0.790 0.059
42.94 (16.15) 38.37 (17.52) 0.372
Vitamin E (mg) Baseline 7.80 (2.86) 9.70 (4.00) 0.034
(2.17, 60)
(2.36, 25)
(3.06, 22)
Final 10.25 (5.07) 7.58 (3.07) 0.031
(2.23, 48)
Vitamin A equiv. (µg) Baseline
655.13 (552.65) 606.35 (468.39) 0.816 0.137 0.024
Final 882.10 (476.73) 613.62 (205.28) 0.013
(2.62, 35)
B carotene equiv. (µg) Baseline
2079.47 (2928.79) 2277.76 (2486.46) 0.893 0.058 0.036
2816.92 (3592.27) 1783.73 (1648.62) 0.021
Potassium (mg) Baseline
2768.52 (1112.38) 2880.05 (856.89) 0.494 0.144 0.042
2781.36 (1077.97) 2616.96 (1357.54) 0.382
Iron (mg) Baseline
10.92 (5.31) 12.48 (5.01) 0.320 0.949 0.008
11.42 (4.86) 10.84 (4.57) 0.567
LC n-3 (mg) Baseline
107.47 (155.75) 215.23 (334.95) 0.043 0.015 0.855
151.54 (315.91) 181.78 (297.08) 0.712
α-Linolenic acid (g) Baseline
1.07 (0.70) 1.17 (0.56) 0.182 0.018 0.048
1.27 (1.60) 1.02 (0.43) 0.014
Bold values indicate a statistically significant finding (p<0.05).
Non-parametric data presented as median (IQR).
P-values (t, df) for independent samples t-test (or MannWhitney U-test for non-parametric data) to compare difference between
ModiMedDiet intervention and control group.
P-values (t, df) for paired samples t-test (or Wilcoxon signed-rank test for non-parametric data) to compare the groups at different
time points (baseline and 3-month assessment).
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specifically for the SMILES trial and based on existing
dietary guidelines and recommendations,
as well as
scientific evidence from the emerging field of nutri-
tional psychiatric epidemiology.
Although individuals with depressive symptoms are
perceived to face many barriers to healthy eating, the
magnitude of dietary changes, observed among diet
group participants for mean intake of whole grain
cereals, vegetables, dairy, pulses, and fish, was
greater than that seen in the seminal PREDIMED
Such differences are potentially explained
by the fact that participants enrolled in the SMILES
trial had poor quality diets at baseline,
were generalizable to the Australian population,
whereas the participants recruited for PREDIMED
were already following a reasonably good
Mediterranean-style food pattern.
Nonetheless, our
findings demonstrate that the ModiMedDiet interven-
tion, can support individuals with MDD to overcome
the many barriers to healthy eating to achieve dietary
improvement. Feedback from participants regarding
how they felt after following the diet were overwhel-
mingly positive and indicative of the high acceptability
of the dietary intervention; I feel great and I feel con-
fident I can continue to make dietary choices that
make me feel good physically AND emotionally;
really indescribably good! On some intricate, internal
level my body felt much better. I feel like my brain
functions with more clarity. I have more energy.
A number of intervention components are likely to
have supported enhanced dietary compliance, such
as the free provision of a food hamper, the individua-
lized approach, goal-setting, and the nutritional coun-
selling (e.g. motivational interviewing and
mindfulness). Dietary adherence is also likely to have
been enhanced by the dissemination of shopping
lists, meal plans, and recipes.
Unfortunately, this
study was unable to provide evidence to indicate that
these beneficial changes will be sustained beyond the
3-month intervention period when participants no
longer receive advice or support from a dietitian.
However, when considering that participants were pro-
vided with practical strategies for purchasing, prepar-
ing and cooking these highly palatable, enjoyable,
and satisfying foods
in real-life conditions, it is
highly plausible that these dietary changes will be
maintained. Sustainability of a Mediterranean-type
diet has been demonstrated in the PREDIMED longi-
tudinal study, but has yet to be shown in a non-
European cohort. This RCT has successfully demon-
strated that a Mediterranean-style diet can be effec-
tively implemented in an Australian population.
The dietary information utilized in this analysis
was obtained from self-reported intake of foods
and beverages using 7-day food diaries, commonly
referred to as the gold standardmeasure.
Moreover, the data were examined by an RA or die-
titian for accuracy of reporting, and under- and over-
were calculated to provide an indicator of
the likely validity of the food diary information. The
food diaries included detailed information about
food choices not available from a food frequency
questionnaire. However, the subjective nature of
self-reported dietary intake assessment methods pre-
sents numerous challenges to obtaining accurate
dietary intake and nutritional status. This limitation
can be overcome by the use of dietary biomarkers,
which are able to objectively assess dietary consump-
tion (or exposure) without the potential bias of self-
reported dietary intake errors.
Carotenoids, as bio-
markers of fruit and vegetable intakes, will be pre-
sented in future manuscripts.
Future recommendations
A key feature of this programme involved the interven-
tion delivery by Accredited Practicing Dietitians. To
promote fidelity, quality, and future scalability
within the context of existing health services, funding
mechanisms that allow qualified dietitians to be subsi-
dized for this activity with clinically depressed popu-
lations would be advantageous. For example, in
Australia, to allow for better access to dietitians, con-
sideration should be made to include dietitians as part
of the GP Mental Health Treatment Plan.
Creating a
Medicare item number for dietitians on the mental
health treatment plan would limit the out-of-pocket
costs incurred, and allow for Medicare rebates of up
to ten individual and ten-group sessions per calendar
year to patients with an assessed mental disorder.
Acknowledging that dietetic services to individuals
with mental health issues are currently limited, other
more accessible mediums for delivering the
ModiMedDiet should be considered. This is especially
pertinent when considering that individuals are unli-
kely to achieve lifestyle and behaviour changes
without support from health professionals. Hence, a
hybrid approach, which uses a combination of digital
platforms (e.g. interactive-web based programs, e-
health initiatives, and social media) delivered by qua-
lified dietitians, may be the best option. This approach
can reach large population numbers at relatively low
cost, enhance patient accessibility, and reduce patient
and clinician burden. The digital technology platform
also addresses multiple key functions of effective
health behaviour change models, e.g. education pro-
vision, health coaching,
monitoring, and social
The SMILES RCT is the first study of its kind, which
employed a qualified dietitian to develop and deliver
an individually tailored ModiMedDiet to individuals
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017 13
Downloaded by [La Trobe University] at 17:11 08 August 2017
with major depression in order to improve diet quality.
An unhealthy diet is one of the leading risk factors for
the non-communicable diseases commonly comorbid
with depression,
whereas this nutrition counselling
intervention was successful at improving the dietary
habits of diet group participants. Thus, implemen-
tation and execution of a dietary counselling interven-
tion, such as the ModiMedDiet, should be considered
as a potentially important therapeutic approach for
the treatment of depression,
which is also likely to
yield a range of health benefits.
Disclaimer statements
Contributors None.
Funding This study was supported by a grant from the
National Health and Medical Research Council of
Australia (NHMRC) (#1021347). Woolworths
Limited provided sponsorship in the form of food vou-
chers for participants. Village cinemas donated cinema
vouchers and Carmans Fine Foods donated muesli
bars for participants. A grant from Meat and
Livestock Australia (2013) funded biochemistry col-
lected and analysed as part of the SMILES trial.
These sponsors had no role in the design, analysis, or
preparation of the manuscript for publication.
Rachelle S. Opie was supported by a National
Health and Medical Research Council (NHMRC)
postgraduate scholarship (# 1075852).
Adrienne ONeil has received funding from Meat
and Livestock Australia and is supported by an
NHMRC ECR Fellowship (#1052865).
Felice N. Jacka has received Grant/Research
support from the Brain and Behaviour Research
Institute, the National Health and Medical Research
Council (NHMRC), Australian Rotary Health, the
Geelong Medical Research Foundation, the Ian
Potter Foundation, Eli Lilly, Meat and Livestock
Australia, Woolworths Limited, and The University
of Melbourne and has received speakers honoraria
from Sanofi-Synthelabo, Janssen-Cilag, Servier,
Pfizer, Health Ed, Network Nutrition, Angelini
Farmaceutica, Metagenics, and Eli Lilly. She is sup-
ported by an NHMRC Career Development
Fellowship (2) (#1108125).
Catherine Itsiopoulos has received funding from the
National Health and Medical Research Council,
University of Melbourne, Deakin University, La Trobe
University, Meat and Livestock Board, Australian
Society for Enteral and Parenteral Nutrition,
Harokopio University in Athens, Commonwealth
Department of Education, Employment and
Workplace relations, and Diabetes Australia, and
SWISSE Wellness P/L. She has received speaker honor-
aria from Astra Zeneca, Boehringer Ingelheim, and
Dairy Australia.
Conflict of interest All authors report no declarations
of interest.
Ethics approval None.
Supplementary material
The underlying research materials for this article
(Supplemental data) can be accessed at 10.1080/
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... For participants in the CALM intervention arm only, the ModiMed Diet Weekly Checklist [51] is used to assess how fully participants are engaging in a modified Mediterranean diet, as promoted by the CALM intervention. Engagement in the CALM physical activity objectives is monitored continually throughout the intervention period via the active minutes output obtained from FitBits that are provided to participants allocated to the CALM 'lifestyle' program at trial commencement. ...
... The CALM lifestyle program has been developed by Accredited Practising Dietitians (APD) and Accredited Exercise Physiologists (EP), with the overarching goal to support positive lifestyle changes for mental health. CALM content is derived from the ModiMed Diet used in the SMILES trial [7,51], the Finnish Diabetes Prevention Study (DPS) [52], the GOAL Program [53], and the Australian Greater Green Triangle Diabetes Prevention Project (GGT DPP) [54]. These studies have all demonstrated successes in achieving improvements in physical and/or mental health outcomes, and hence were considered ideal models in which to develop CALM. ...
Full-text available
Background There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a ‘first-line’, ‘non-negotiable’ treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. Methods The study is being conducted in partnership with Barwon Health’s Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. Discussion If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820, Registered 8 April 2021.
... Growing evidence from intervention studies on MedDiet demonstrated generally a good compliance with a Mediterranean diet among the patients (need the complicate rate). The flexibility of MedDiet with the emphasis on encouraging positive behaviour change and improving dietary quality through displacement of discretionary items with healthy nutrient-dense foods instead of prohibiting of certain goods allow better compliance on MedDiet [34]. ...
... The notion of the MedDiet has undergone progressive evolution over half a decade to what we now observe as a dietary pattern with nutrition, food, cultures, people, environment, and sustainability all interacting into a new model that is sustainable. The flexibility of MedDiet that can be modified and accommodated to different cultural differences, food systems, and seasonal variations makes it transferable not only in Mediterranean basins, but in non-Mediterranean populations including multiethnic populations in Australia [34] and other countries. Global food demand is increasing rapidly with the presence of multiple drivers, including population growth, dietary shifts, and economic development. ...
Full-text available
Objective: Cardiovascular disease (CVD) is the leading cause of disability and death in many countries. Together with CVD, Type 2 diabetes mellitus (T2DM) accounts for more than 80% of all premature non-communicable disease deaths. The protective effect of the Mediterranean diet (MedDiet) on CVD and its risk factors, including T2DM, has been a constant topic of interest. Notwithstanding, despite the large body of evidence, scientists are concerned about the challenges and difficulties of the application of MedDiet. This review aims to explore the motivations and challenges for using MedDiet in patients with CVD and T2DM. Design: An electronic search was conducted for articles about MedDiet published in PubMed, ScienceDirect, Scopus, and Web of Science up to December 2021, particularly on CVD and T2DM patients. From a total of 1536 studies, the final eligible set of 108 studies was selected. Study selection involved three iterations of filtering. Results: Motivation to apply MedDiet was driven by the importance of studying the entire food pattern rather than just one nutrient, the health benefits, and the distinct characteristics of MedDiet. Challenges of the application of MedDiet include lacking universal definition and scoring of MedDiet. Influences of nutritional transition that promote shifting of traditional diets to Westernized diets further complicate the adherence of MedDiet. The challenges also cover the research aspects, including ambiguous and inconsistent findings, the inexistence of positive results, limited evidence, and generalization in previous studies. The review revealed that most of the studies recommended that future studies are needed in terms of health benefits, describing the potential benefits of MedDiet, identifying the barriers, and mainly discussing the effect of MedDiet in different populations. Conclusions: In general, there is consistent and strong evidence that MedDiet is associated inversely with CVD risk factors and directly with glycemic control. MedDiet is the subject of active and diverse research despite the existing challenges. This review informs the health benefits conferred by this centuries-old dietary pattern and highlights MedDiet could possibly be revolutionary, practical, and non-invasive approach for the prevention and treatment CVD and T2DM.
... Retention rates of 93.9% and 73.5% were observed for the dietary intervention and social support control group, respectively. 24 We identifi ed several intervention components that are likely to have supported enhanced dietary compliance that could be translated to digital delivery. Th ese included goal setting, motivational interviewing, and providing practical tools such as shopping lists, meal plans, and recipes. ...
... 25 Th ere were additional components, thought to aid adherence, that could not be replicated in a digital environment, such as the provision of food hampers. 24 We adapted some of the SMILEs content to a digital form and tested its suitability for adults experiencing mental health concerns. Th e results of our mHealth pilot showed that participants who set goals and self-monitored their diet and mood, along with watching the dietary advice videos, achieved a signifi cantly larger improvement in diet quality compared with participants with other usage patterns (eg, just watching the dietary advice videos or only using the self-monitoring tools). ...
... Article delivery techniques (11)(12)(13) . Other studies support this idea that adherence is likely to be improved when participants are provided with shopping lists, meal plans, and recipes (14) . ...
Full-text available
Background: A Mediterranean Diet (MD) appears to be beneficial in NAFLD patients in Mediterranean countries, however the acceptability of a MD in non-Mediterranean populations has not been thoroughly explored. This study aimed to explore the acceptability, through understanding the barriers and enablers of MD and low-fat diet (LFD) interventions as perceived by Australian adults from multicultural backgrounds, with NAFLD, who participated. Methodology: Semi-structured telephone interviews were performed with 23 NAFLD trial participants at the end of a 12-week dietary intervention in a multicentre, parallel, randomised clinical trial. Data was analysed using thematic analysis. Results: Participants reported that they enjoyed taking part in the MD and LFD interventions and perceived that they had positive health benefits from their participation. Compared to the LFD, the MD group placed greater emphasis on enjoyment and intention to maintain dietary changes. Novelty, convenience and the ability to swap food/meals were key enablers for the successful implementation for both of the dietary interventions. Flavour and enjoyment of food, expressed more prominently by MD intervention participants, were fundamental components of the diets with regard to reported adherence and intention to maintain dietary change. Conclusions: Participants randomised to the MD reported greater acceptability of the diet than those randomised to the LFD, predominantly related to perceived novelty and palatability of the diet. This article is protected by copyright. All rights reserved.
... A total of 31 of the dietary support group and 25 of the controls completed the study at 12 weeks and after further analysis, the study concluded that this type of nutritional intervention helped in the clinical management of MDD, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) [206]. The dietary protocol for these patients is described in [207]. Extra virgin olive oil (EVOO), one of the most representative elements of the MDiet has recently proven antidepressant effects in patients with severe MDD, but not in those with mild to moderate [208]. ...
Full-text available
Major Depressive Disorder (MDD) is a growing disabling condition affecting around 280 million people worldwide. This complex entity is the result of the interplay between biological, psychological, and sociocultural factors, and compelling evidence suggests that MDD can be considered a disease that occurs as a consequence of an evolutionary mismatch and unhealthy lifestyle habits. In this context, diet is one of the core pillars of health, influencing multiple biological processes in the brain and the entire body. It seems that there is a bidirectional relationship between MDD and malnutrition, and depressed individuals often lack certain critical nutrients along with an aberrant dietary pattern. Thus, dietary interventions are one of the most promising tools to explore in the field of MDD, as there are a specific group of nutrients (i.e., omega 3, vitamins, polyphenols, and caffeine), foods (fish, nuts, seeds fruits, vegetables, coffee/tea, and fermented products) or dietary supplements (such as S-adenosylmethionine, acetyl carnitine, creatine, amino acids, etc.), which are being currently studied. Likewise, the entire nutritional context and the dietary pattern seem to be another potential area of study, and some strategies such as the Mediterranean diet have demonstrated some relevant benefits in patients with MDD; although, further efforts are still needed. In the present work, we will explore the state-of-the-art diet in the prevention and clinical support of MDD, focusing on the biological properties of its main nutrients, foods, and dietary patterns and their possible implications for these patients.
... However, the improvement in the adherence to the MD was significantly higher in the intervention group after 2 years of follow-up. These results are similar to shown in a previous face-to-face intervention study developed in the Mediterranean area with depressed patients [24]. In concordance to the SMILES trial, we found significant differences between groups in fruits and olive oil consumption [5]. ...
Full-text available
Background: There is substantial evidence supporting that remote interventions are useful to change dietary habits. However, the effect of a remote intervention based on Mediterranean diet (MD) in depressive patients has been less explored. Objective: This study aims to assess the effectiveness of a remotely provided Mediterranean diet-based nutritional intervention in the context of a secondary prevention trial of depression. Methods: The PREDIDEP study was a 2-year multicenter, randomized, single-blinded trial designed to assess the effect of the MD enriched with extra virgin olive oil (EVOO) on the prevention of depression recurrence. The intervention group received usual care for depressed patients and remote nutritional intervention every three months which included phone contacts and web-based interventions; and the control group, usual care. At baseline and at 1-year and 2-year follow-up, the 14-item MD Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire (FFQ) were collected by a dietitian. Mixed effects linear models were used to assess changes in nutritional variables according to the group of intervention. The trial was registered at NCT03081065. Results: Compared with control group, the MD intervention group showed more adherence to MD (between-group difference: 2.76; 95% CI 2.13-3.39; p < 0.001); and a healthier diet pattern with a significant increase in the consumption of olive oil (p < 0.001), and a significant reduction in refined cereals (p = 0.031) after 2 years of intervention. Conclusions: The remote nutritional intervention increases adherence to the MD among recovered depression patients.Trial registration: identifier: NCT03081065.
... Among longitudinal studies, MD patterns have been linked with lower incidence of mental conditions, such as depression in Spain, Italy, US and Australia (90)(91)(92)(93)(94)(95)(96)(97). Two additional trials (SMILES and MEAL) are evaluating the impact of implementing a MD pattern on depression prevention and/or treatment (98,99). ...
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In this landmark e-book of Frontiers of Nutrition, the authors from several Latin American nations provide findings that seed a plant-based research agenda for Latin America. Cairo et al. provide findings clearly showing how obesity and overweight have reached the rural areas of Brazil. The emergence of processed and ultra-processed foods in diet patterns across the lifespan in Latin America is shown in pre-schoolers in Chile by Araya et al. and reviewed for the entire region by Matos et al.. Despite these strong trends, there remains a paucity of research infrastructure in Latin America for culturally tailored dietary intervention trials to reverse the nutrition transition away from cultural diets based on minimally processed whole plant foods and fewer animal products. The supplement continues the build of this emergent research infrastructure for dietary intervention. Sanchez Urbano et al. provide evidence of the feasibility and acceptability of dietary intervention advice in the Latin American context. Loureiro et al. provide insights from diet patterns in Brazilian adults, and Contreras-Guillén et al. is innovating dietary recall methods for Argentina. Figueroa et al. tackle the question of whether a plant-based Mediterranean diet can be adapted for the Latin American region. Taken together, the supplement articles herein are a stride forward in the path to reverse the nutrition transition that is creating a sizable noncommunicable disease burden in Latin America.
... In recent years, dietary interventions aimed at restoration of proper gut to brain communication have come to the fore as strategies for the management of symptoms of many mood disorders. For example, the Mediterranean diet has been shown to have positive effects by reducing the symptoms of depression in humans McMillan et al., 2011;Opie et al., 2018), while a diet high in polyunsaturated fatty acids (PUFAs) has been shown to reduce the symptoms of anxiety in a cohort of undergraduate college students (Yehuda et al., 2005). A combination of eicosapentaenoic acid and docosahexaenoic acid (DHA), two PUFAs, has also been shown to reduce anxiety-like behaviour in rats (Pusceddu et al., 2015a) and reverse selective effects of ELS (Pusceddu et al., 2015b). ...
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Nutritional approaches have emerged over the past number of years as suitable interventions to ameliorate the enduring effects of early life stress. Maternal separation (MS) is a rodent model of early life stress which induces widespread changes across the microbiota-gut-brain axis. Milk fat globule membrane (MFGM) is a neuroactive membrane structure that surrounds milk fat globules in breast milk and has been shown to have positive health effects in infants, yet mechanisms behind this are not fully known. Here, we investigated the effects of MFGM supplementation from birth on a variety of gut-brain signalling pathways in MS and non-separated control animals across the lifespan. Specifically, visceral sensitivity as well as spatial and recognition memory were assessed in adulthood, while gut barrier permeability, enteric nervous system (ENS) and glial network structure were evaluated in both early life and adulthood. MS resulted in visceral hypersensitivity, which was ameliorated to a greater extent by supplementation with MFGM from birth. Modest effects of both MS and dietary supplementation were noted on spatial memory. No effects of MS were observed on enteric neuronal or glial networks in early life or adulthood, however an increase in the immunoreactivity of βIII-tubulin in adult colonic myenteric ganglia was noted in the MFGM intervention non-separated group. In conclusion, dietary supplementation with MFGM from birth is sufficient to block MS-induced visceral hypersensitivity, highlighting its potential value in visceral pain-associated disorders, but future studies are required to fully elucidate the mechanistic role of this supplementation on MS-induced visceral pain.
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Mediterranean populations enjoy the health benefits of a Mediterranean diet (MedDiet), but is it feasible to implement such a pattern beyond the Mediterranean region? The MedLey trial, a 6-month MedDiet intervention vs habitual diet in older Australians, demonstrated that the participants could maintain high adherence to a MedDiet for 6 months. The MedDiet resulted in improved systolic blood pressure (BP), endothelial dilatation, oxidative stress, and plasma triglycerides in comparison with the habitual diet. We sought to determine if 12 months after finishing the MedLey study, the participants maintained their adherence to the MedDiet principles and whether the reduction in the cardiovascular disease (CVD) risk factors that were seen in the trial were sustained. Participants completed a food frequency questionnaire, and a 15-point MedDiet adherence score (MDAS; greater score = greater adherence) was calculated. Home BP was measured over 6 days, BMI was assessed, and fasting plasma triglycerides were measured. The data were analysed using intention-to-treat linear mixed effects models with a group × time interaction term, comparing data at baseline, 2, 4, and 18 months (12 months post-trial). At 18 months (12 months after finishing the MedLey study), the MedDiet group had a MDAS of 7.9 ± 0.3, compared to 9.6 ± 0.2 at 4 months (p < 0.0001), and 6.7 ± 0.2 (p < 0.0001), at baseline. The MDAS in the HabDiet group remained unchanged over the 18-month period (18 months 6.9 ± 0.3, 4 months 6.9 ± 0.2, baseline 6.7 ± 0.2). In the MedDiet group, the consumption of olive oil, legumes, fish, and vegetables remained higher (p < 0.01, compared with baseline) and discretionary food consumption remained lower (p = 0.02) at 18 months. These data show that some MedDiet principles could be adhered to for 12 months after finishing the MedLey trial. However, improvements in cardiometabolic health markers, including BP and plasma triglycerides, were not sustained. The results indicate that further dietary support for behaviour change may be beneficial to maintaining high adherence and metabolic benefits of the MedDiet.
Background Although multiple studies and meta-analyses have documented the rapid antidepressive efficacy of ketamine, there are numerous questions regarding the practical use in the clinical routine that are still unanswered.Objective Based on personal clinical experience, by comparison and supplementation of the current data situation, answers are given to questions regarding the practical use of ketamine for depression that have not yet been satisfactorily clarified.Material and methodsThe clinical experiences with antidepressive treatment using ketamine over more than 5 years were evaluated with respect to the questions at hand. This was followed by a qualitative comparison of these results with those of a narrative literature search.ResultsA total of 72 patients (unipolar depression n = 53, bipolar depression n = 16, schizoaffective depression n = 3) were included in the analysis of this cohort. A statistically significant reduction of depressive symptoms and suicidal ideation after S-ketamine treatment was found. Of the patients 61% suffered from at least one secondary diagnosis. A dose of 0.5 mg/kg body weight of S‑ketamine at a frequency of three times per week was shown to be effective. The treatment appears to be safe with respect to urotoxic side effects, combination treatment with tranylcypromine and in comorbid posttraumatic stress disorder.Conclusion Ketamine appears to be a safe and effective option for the treatment of unipolar and bipolar depression.
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Background The possible therapeutic impact of dietary changes on existing mental illness is largely unknown. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes. Methods ‘SMILES’ was a 12-week, parallel-group, single blind, randomised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. The control condition comprised a social support protocol to the same visit schedule and length. Depression symptomatology was the primary endpoint, assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) at 12 weeks. Secondary outcomes included remission and change of symptoms, mood and anxiety. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. The robustness of estimates was investigated through sensitivity analyses. Results We assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33; control, n = 34). Of these, 55 were utilising some form of therapy: 21 were using psychotherapy and pharmacotherapy combined; 9 were using exclusively psychotherapy; and 25 were using only pharmacotherapy. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group, t(60.7) = 4.38, p < 0.001, Cohen’s d = –1.16. Remission, defined as a MADRS score <10, was achieved for 32.3% (n = 10) and 8.0% (n = 2) of the intervention and control groups, respectively (χ² (1) = 4.84, p = 0.028); number needed to treat (NNT) based on remission scores was 4.1 (95% CI of NNT 2.3–27.8). A sensitivity analysis, testing departures from the missing at random (MAR) assumption for dropouts, indicated that the impact of the intervention was robust to violations of MAR assumptions. Conclusions These results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder, the benefits of which could extend to the management of common co-morbidities. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered on 29 February 2012.
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Background: The Global Burden of Disease, Injuries, and Risk Factor study 2013 (GBD 2013) is the first of a series of annual updates of the GBD. Risk factor quantification, particularly of modifiable risk factors, can help to identify emerging threats to population health and opportunities for prevention. The GBD 2013 provides a timely opportunity to update the comparative risk assessment with new data for exposure, relative risks, and evidence on the appropriate counterfactual risk distribution. Methods: Attributable deaths, years of life lost, years lived with disability, and disability-adjusted life-years (DALYs) have been estimated for 79 risks or clusters of risks using the GBD 2010 methods. Risk–outcome pairs meeting explicit evidence criteria were assessed for 188 countries for the period 1990–2013 by age and sex using three inputs: risk exposure, relative risks, and the theoretical minimum risk exposure level (TMREL). Risks are organised into a hierarchy with blocks of behavioural, environmental and occupational, and metabolic risks at the first level of the hierarchy. The next level in the hierarchy includes nine clusters of related risks and two individual risks, with more detail provided at levels 3 and 4 of the hierarchy. Compared with GBD 2010, six new risk factors have been added: handwashing practices, occupational exposure to trichloroethylene, childhood wasting, childhood stunting, unsafe sex, and low glomerular filtration rate. For most risks, data for exposure were synthesised with a Bayesian meta-regression method, DisMod-MR 2.0, or spatial-temporal Gaussian process regression. Relative risks were based on meta-regressions of published cohort and intervention studies. Attributable burden for clusters of risks and all risks combined took into account evidence on the mediation of some risks such as high body-mass index (BMI) through other risks such as high systolic blood pressure and high cholesterol. Findings: All risks combined account for 57·2% (95% uncertainty interval [UI] 55·8–58·5) of deaths and 41·6% (40·1–43·0) of DALYs. Risks quantified account for 87·9% (86·5–89·3) of cardiovascular disease DALYs, ranging to a low of 0% for neonatal disorders and neglected tropical diseases and malaria. In terms of global DALYs in 2013, six risks or clusters of risks each caused more than 5% of DALYs: dietary risks accounting for 11·3 million deaths and 241·4 million DALYs, high systolic blood pressure for 10·4 million deaths and 208·1 million DALYs, child and maternal malnutrition for 1·7 million deaths and 176·9 million DALYs, tobacco smoke for 6·1 million deaths and 143·5 million DALYs, air pollution for 5·5 million deaths and 141·5 million DALYs, and high BMI for 4·4 million deaths and 134·0 million DALYs. Risk factor patterns vary across regions and countries and with time. In sub-Saharan Africa, the leading risk factors are child and maternal malnutrition, unsafe sex, and unsafe water, sanitation, and handwashing. In women, in nearly all countries in the Americas, north Africa, and the Middle East, and in many other high-income countries, high BMI is the leading risk factor, with high systolic blood pressure as the leading risk in most of Central and Eastern Europe and south and east Asia. For men, high systolic blood pressure or tobacco use are the leading risks in nearly all high-income countries, in north Africa and the Middle East, Europe, and Asia. For men and women, unsafe sex is the leading risk in a corridor from Kenya to South Africa. Interpretation: Behavioural, environmental and occupational, and metabolic risks can explain half of global mortality and more than one-third of global DALYs providing many opportunities for prevention. Of the larger risks, the attributable burden of high BMI has increased in the past 23 years. In view of the prominence of behavioural risk factors, behavioural and social science research on interventions for these risks should be strengthened. Many prevention and primary care policy options are available now to act on key risks.
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Background: Major depressive disorder is a common, chronic condition that imposes a substantial burden of disability globally. As current treatments are estimated to address only one-third of the disease burden of depressive disorders, there is a need for new approaches to prevent depression or to delay its progression. While in its early stages, converging evidence from laboratory, population research, and clinical trials now suggests that dietary patterns and specific dietary factors may influence the risk for depression. However, largely as a result of the recency of the nutritional psychiatry field, there are currently no dietary recommendations for depression. Aim: The aim of this paper is to provide a set of practical dietary recommendations for the prevention of depression, based on the best available current evidence, in order to inform public health and clinical recommendations. Results: Five key dietary recommendations for the prevention of depression emerged from current published evidence. These comprise: (1) follow 'traditional' dietary patterns, such as the Mediterranean, Norwegian, or Japanese diet; (2) increase consumption of fruits, vegetables, legumes, wholegrain cereals, nuts, and seeds; (3) include a high consumption of foods rich in omega-3 polyunsaturated fatty acids; (4) replace unhealthy foods with wholesome nutritious foods; (5) limit your intake of processed-foods, 'fast' foods, commercial bakery goods, and sweets. Conclusion: Although there are a number of gaps in the scientific literature to date, existing evidence suggests that a combination of healthful dietary practices may reduce the risk of developing depression. It is imperative to remain mindful of any protective effects that are likely to come from the cumulative and synergic effect of nutrients that comprise the whole-diet, rather than from the effects of individual nutrients or single foods. As the body of evidence grows from controlled intervention studies on dietary patterns and depression, these recommendations should be modified accordingly.
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Lifestyle factors are important in the development of chronic diseases, such as heart disease, respiratory disease, and diabetes, and chronic disease risk can be reduced by changes in lifestyle behaviors linked to these conditions. The use of mass media and community-wide strategies targeting these behaviors has been extensively evaluated since the 1970s. This review summarizes some examples of interventions and their use of media conducted within the old communications landscape of the 1970s and 1980s and the key lessons learned from their design, implementation, and evaluation. We then consider the potential and evidence base for using contemporary technology applications and platforms-within the new communications landscape-to improve the prevention and management of lifestyle-related chronic diseases in the future. We discuss the implications and adaptation of lessons derived from the ways in which new technologies are being used in commercial and political contexts and their relevance for public health. Finally, we consider some recent examples of applying new technologies to public health issues and consider some of the challenges in this rapidly developing field. Expected final online publication date for the Annual Review of Public Health Volume 36 is March 18, 2015. Please see for revised estimates.
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Objective Non-pharmacological approaches to the treatment of depression and anxiety are of increasing importance, with emerging evidence supporting a role for lifestyle factors in the development of these disorders. Observational evidence supports a relationship between habitual diet quality and depression. Less is known about the causative effects of diet on mental health outcomes. Therefore a systematic review was undertaken of randomised controlled trials of dietary interventions that used depression and/or anxiety outcomes and sought to identify characteristics of programme success. Design A systematic search of the Cochrane, MEDLINE, EMBASE, CINAHL, PubMed and PyscInfo databases was conducted for articles published between April 1971 and May 2014. Results Of the 1274 articles identified, seventeen met eligibility criteria and were included. All reported depression outcomes and ten reported anxiety or total mood disturbance. Compared with a control condition, almost half (47 %) of the studies observed significant effects on depression scores in favour of the treatment group. The remaining studies reported a null effect. Effective dietary interventions were based on a single delivery mode, employed a dietitian and were less likely to recommend reducing red meat intake, select leaner meat products or follow a low-cholesterol diet. Conclusions Although there was a high level of heterogeneity, we found some evidence for dietary interventions improving depression outcomes. However, as only one trial specifically investigated the impact of a dietary intervention in individuals with clinical depression, appropriately powered trials that examine the effects of dietary improvement on mental health outcomes in those with clinical disorders are required.
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The Mediterranean diet has been linked to a number of health benefits, including reduced mortality risk and lower incidence of cardiovascular disease. Definitions of the Mediterranean diet vary across some settings, and scores are increasingly being employed to define Mediterranean diet adherence in epidemiological studies. Some components of the Mediterranean diet overlap with other healthy dietary patterns, whereas other aspects are unique to the Mediterranean diet. In this forum article, we asked clinicians and researchers with an interest in the effect of diet on health to describe what constitutes a Mediterranean diet in different geographical settings, and how we can study the health benefits of this dietary pattern.
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To update previous meta-analyses of cohort studies that investigated the association between the Mediterranean diet and health status and to utilize data coming from all of the cohort studies for proposing a literature-based adherence score to the Mediterranean diet. We conducted a comprehensive literature search through all electronic databases up to June 2013. Cohort prospective studies investigating adherence to the Mediterranean diet and health outcomes. Cut-off values of food groups used to compute the adherence score were obtained. The updated search was performed in an overall population of 4 172 412 subjects, with eighteen recent studies that were not present in the previous meta-analyses. A 2-point increase in adherence score to the Mediterranean diet was reported to determine an 8 % reduction of overall mortality (relative risk = 0·92; 95 % CI 0·91, 0·93), a 10 % reduced risk of CVD (relative risk = 0·90; 95 % CI 0·87, 0·92) and a 4 % reduction of neoplastic disease (relative risk = 0·96; 95 % CI 0·95, 0·97). We utilized data coming from all cohort studies available in the literature for proposing a literature-based adherence score. Such a score ranges from 0 (minimal adherence) to 18 (maximal adherence) points and includes three different categories of consumption for each food group composing the Mediterranean diet. The Mediterranean diet was found to be a healthy dietary pattern in terms of morbidity and mortality. By using data from the cohort studies we proposed a literature-based adherence score that can represent an easy tool for the estimation of adherence to the Mediterranean diet also at the individual level.
Abstract The aim of this research was to examine the cost of a diet generally regarded as healthy, a Swedish version of the Mediterranean diet, and to compare it with the cost of an ordinary Swedish diet. A total of 30 individuals provided detailed dietary data collected in a randomized intervention study, examining the effect of dietary change to a Mediterranean-style diet in patients with rheumatoid arthritis (Mediterranean group, n = 16, control group, n = 14). The data, covering 1-month dietary intake, were examined with three different diet quality indicators to see whether the Mediterranean group consumed a healthier diet than the control group. All diet quality indicators showed that the Mediterranean group consumed a healthier diet than the control group. Consumer food prices were used to analyse the cost of the different diets. In immediate consumer cost terms, eating a healthier diet was more expensive when differences in energy intake were discounted. However, non-energy adjusted costs showed no significant difference between the groups. Hence, if one of the reasons for choosing a healthier diet is to achieve weight loss – by consuming less energy – it is possible that healthier eating is not more expensive.