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Nutritional Neuroscience
An International Journal on Nutrition, Diet and Nervous System
ISSN: 1028-415X (Print) 1476-8305 (Online) Journal homepage: http://www.tandfonline.com/loi/ynns20
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: http://dx.doi.org/10.1080/1028415X.2017.1312841
© 2017 The Author(s). Published by Informa
UK Limited, trading as Taylor & Francis
Group
View supplementary material
Published online: 19 Apr 2017. Submit your article to this journal
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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 O’Neil2,3, Felice N. Jacka 2,4,5,6,
Josephine Pizzinga2, Catherine Itsiopoulos1
1
School of Allied Health, La Trobe University, Bundoora, VIC, Australia,
2
Food and Mood Centre, IMPACT SRC,
Deakin University, Geelong, VIC, Australia,
3
Melbourne School of Population and Global Health, The University
of Melbourne, Parkville, VIC, Australia,
4
Department of Psychiatry, University of Melbourne, Parkville, VIC,
Australia,
5
Centre for Adolescent Health, Murdoch Childrens Research Institute, Parkville, VIC, Australia,
6
Black
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
Introduction
Depressive disorders are one of the leading causes of
disease burden globally.
1,2
In many Western countries
like Australia, one in five individuals aged 16–85 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.
3
While remarkable advances have
been made in the detection and management of
depressive disorders over the past decade,
4
the high
worldwide prevalence of depression in both developed
and developing countries
5,6
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 reativecommons.org/
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.
Email: r.opie@latrobe.edu.au;rachellesopie@gmail.com
1
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diet (rich in fresh fruits, vegetables, fish, extra virgin
olive oil, and whole grains) on depression risk.
7–9
A
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.
10,11
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.
9
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.
12,13
Negative mood
states can stimulate a preferential desire to consume
salty, sweet, or high-fat foods.
12,14
Importantly,
depression is also commonly associated with fatigue
and apathy,
15
which may have impact on an individ-
ual’s motivation to engage in healthy dietary
habits,
16
a reduced desire to cook,
17
and depleted
energy for activities such as grocery shopping and
meal preparation.
18,19
As a result of decreased concen-
tration, decreased mental endurance, and slowed
thinking
15
individuals may also find learning new
recipes, developing cooking skills, or performing
meal preparation challenging.
18,19
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.
20
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.
21
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.
Methods
Overview of the SMILES study
Detailed study methods of the SMILES trial have been
published previously.
22
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-
ing’
23
). Recruitment and intervention delivery
occurred from October 2012 to July 2015.
Participants’eligibility
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),
24
and
had current poor quality diets as determined by a
score of 75 or less (out of 104) in a Dietary
Screening Tool.
25
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.
25
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
setting.
Social support control group
The control condition (social support) comprised a
befriending protocol.
23
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.
23
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
2007),
26
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
27
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
28
were used to calculate EER. Under-reporters were
defined as EI:EER <0.76, acceptable reporters
defined as EI:EER 0.76–1.24, and over-reporters
defined as EI:EER >1.24.
27
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.,
29,30
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,
31
and evidence from the emerging
field of nutritional psychiatry,
32
we created a ‘modi-
fied’Mediterranean diet (ModiMedDiet) for the
needs of our patient population.
Framework
The ModiMedDiet was primarily constructed using
the Dietary Guidelines for Adults in Greece
33
and
the Mediterranean-type diet principles from the
PREDIMED study.
34
Additionally, the Australian
Dietary Guidelines
35
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
Government’s endorsed guidelines relevant to cardio-
vascular disease health were used due to the strong
overlap between depression and cardio-metabolic con-
ditions.
36–38
Finally, publications by Itsiopoulos
et al.,
39
and Kouris-Blazos et al.,
8,31,40,41
were utilized
to ensure that the diet closely resembled the nutrient
profile of the traditional Mediterranean diet.
Like the traditional Mediterranean diet,
34,42
the
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.
43
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.
44
Promoting ade-
quate lean red meat intake is of further relevance
when considering that 38% of Australian women
aged 19–50 years have inadequate intakes of iron.
45
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,
26
the
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
females,
36
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
models,
33,35
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.
46,47
Instead, the primary
focus was on achieving positive behaviour change
and improving dietary quality through displacement
of ‘discretionary items’with 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,
34
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 5–8 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
1
2cup cooked rice /
pasta (50–60 g)
1
2cup cooked other
grains (50–60 g)
1
4cup oats or muesli
(30 g)
2/3 cup breakfast
cereal flakes (30 g)
2 Weet-Bix
3 crisp breads
Includes:
•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
Excludes:
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-
crackers
2. Vegetables 6 per day
1
2cup cooked
vegetables
(75–100 g)
1 cup leafy greens
(75–100 g)
1 tomato
1 small potato
(75–100 g)
Starchy vegetables
(75–100 g)
Include tomatoes and
leafy greens daily
Maximum 1 potato per
day
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)
11
2tablespoons dried
fruit (30 g)
Limit fruit juice to 1
2cup
per day (125 mL)
4. Dairy 2–3 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
Includes:
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
Includes:
LSA, pumpkin seeds, sunflower seeds,
etc.
6. Legumes and Pulses 3–4 per week
Tips: select dried or canned legumes
(e.g. chickpeas, lentils, baked
beans, kidney beans)
1
2cup legumes
(75–100 g)
75 g hummus
100 g tofu
Includes:
Falafel
7. Lean Red Meat 3–4 per week
Tips: select lean meat and remove
the fat
65–100 g lean red meat
1
2cup mince
2 small chops
Includes:
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 1–2 times per
week (or other fish
high in LC omega-3
PUFAs)
Includes:
All fish e.g. white and oily fish.
Tinned, fresh, or frozen fish.
Smoked salmon, sardines, scallops,
prawns, oysters, squid.
9. Poultry 2–3 per week
Tips: remove the skin 80–100 g poultry Includes:
Chicken, turkey, duck
10. Eggs Up to 6 eggs per week
1 egg (60 g)
Continued
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
documentation.
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,
48
mindful-
ness
49
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.
50
Findings from a systematic review
51
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
environments
52
conducive to the development of a
trusting relationship.
53
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-
ence.
53
This allowed the dietitian to understand the
patient’s needs and concerns. Collaboration between
the dietitian and patient was essential, and flexibility
allowed the dietitian to tailor individual sessions to
the patient’s 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.
Incentives
To encourage dietary adherence consistent with the
strategies used by the PREDIMED study,
34
and
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)
Includes:
Sweets, highly processed cereals, chips
and savoury pastries, fried food, fast-
food, fatty meat, processed meats, dairy
desserts, sugary drinks, condiments
Alcohol
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
day
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
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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
Nutrient
ModiMedDiet
avg /day
Reference diets NRVs
National Health and Medical
Research Council (NHMRC)
36
Itsiopoulos
et al.
39
Kouris-Blazos
et al.
40
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(♂♀ 19–50)
AI: 10 ug/d(♂♀ 51–70)
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
(µg)
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: 460–920 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(♂♀ 19–50)
|RDI: 1000 mg/d(♂51–70) |RDI:
1300 mg/d(♀51–70)
Phosphorus (mg) 2284.87 ——|RDI: 1000 mg/d(♂♀)
Iron (mg) 18.00 ——RDI: 8 mg/d(♂)
RDI: 18 mg/d(♀19–50)
RDI: 8 mg/d(♀51–70)
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 15–25% of E
kcal from fat 39.62% of E 40% of E 40–45% of E 20–35% of E
kcal from saturated fat 9.00% of E —10–12% of E —
kcal from carbohydrate 36.00% of E 44% of E 38–44% of E
(28% complex)
45–65% of E
kcal from sugar 16.35% of E —12% refined of
E
—
kcal from alcohol 1.69% 4% of E from red
wine
<5% of E —
kcal from mono 20.27% of E
(53.77% of total
fat)
>50% of total fat 20–22% 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(♀)
Continued
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Table 2 Continued
Nutrient
ModiMedDiet
avg /day
Reference diets NRVs
National Health and Medical
Research Council (NHMRC)
36
Itsiopoulos
et al.
39
Kouris-Blazos
et al.
40
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.
36
Table 3 ModiMedDiet session details
Session #
Task
resources Comments
1•Introduce the Dietitian and the intervention purpose,
scope, and structure.
•Assess current eating practices (complete NCP –Diet
History).
oIdentify habitual behaviours, dieting and weight
history, motivators, barriers, and ambivalence to
change.
•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.
2–6•Review goals from previous week.
•Revisit areas of particular interest or concern, or
challenges faced. Facilitate discussion and problem-
solving.
•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
participants’interests 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 ModiMedDiet–Top 10 Tips at each session
to highlight and reiterate the primary dietary
objectives.
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’.
7•Review 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
54
and
the Framingham Offspring Cohort
55
–a criterion-
based diet score, which uses pre-defined absolute or
normative goals of consumption for specific food
items, independent of the individual’s 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 participant’s average total EI. This
information was obtained from FoodWorks7,
26
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.
56
The
independent samples t-test was used to compare the
mean scores between groups of normally distributed
continuous variables, whereas the Mann–Whitney 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). Kruskal–Wallis test was used
as the non-parametric alternative.
Results
Recruitment
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.
57
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 ‘acceptable’reporters, while 15 and
10% were under- and over-reporters, respectively.
27
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
Cohen’sdof 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
PREDIMED study.
58
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).
Discussion
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.
21
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
ModiMedDiet
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
P
b
(t,df)
P
c
(t,df)
Diet Control
Serves/Day
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)
0.002
(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
Final
a
2.05 (1.63) 1.53 (1.08) 0.062
Fruit Baseline
a
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)
0.001
(3.70, 25)
0.390
(−0.88, 23)
Final 1.59 (0.74) 1.36 (0.79) 0.309 (1.03, 48)
Nuts Baseline
a
0.00 (0.60) 0.13 (0.56) 0.17 (0.63) 0.13 (0.83) 0.187 0.256 0.673
Final
a
0.44 (0.65) 0.16 (0.71) 0.440
Olive Oil Baseline
a
0.00 (0.20) 0.42 (0.49) 0.00 (0.25) −0.10 (0.24) 0.750 0.000 0.037
Final
a
0.25 (0.76) 0.00 (0.08) 0.000
Serves /Week
Pulses Baseline
a
0.00 (0.60) 1.40 (2.39) 0.12 (4.55) −0.70 (3.57) 0.107 0.008 0.300
Final
a
0.18 (2.97) 0.00 (2.33) 0.198
Red Meat Baseline
a
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
a
0.44 (1.80) 1.12 (2.65) 1.38 (2.50) 0.23 (2.16) 0.121 0.042 0.852
Final
a
1.00 (3.04) 1.10 (2.95) 0.896
Chicken Baseline
a
3.00 (5.23) −0.14 (4.26) 1.94 (2.99) 0.01 (3.34) 0.104 0.757 0.853
Final
a
2.38 (3.08) 2.00 (2.63) 0.565
Eggs Baseline
a
1.00 (2.00) 0.40 (1.83) 1.88 (3.13) 0.12 (2.19) 0.077 0.297 0.722
Final
a
2.00 (3.00) 1.08 (4.00) 0.984
Extras Baseline
a
49.62 (38.64) −21.76 (16.01) 39.44 (33.85) −1.36 (16.63) 0.052 0.000 0.786
Final
a
20.45 (34.66) 35.66 (36.03) 0.361
Bold values indicate a statistically significant finding (p<0.05).
a
Non-parametric data presented as median (IQR).
b
P-values (t, df) for independent samples t-test (or Mann–Whitney U-test for non-parametric data).
c
P-values (t, df) for paired samples t-test (or Wilcoxon signed-rank test for non-parametric data).
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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)
P
b
(t,df)
P
c
(t,df)
Mean (SD) Diet Control
Average Energy (kcal) Baseline 2061 (632) 2057 (438) 0.980
(0.03, 60)
0.355
(−0.94, 25)
0.023
(−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)
0.009
(2.83, 25)
0.683
(−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)
0.212
(1.28, 25)
0.400
(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)
0.500
(−0.68, 25)
0.201
(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
Final
a
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
Final
a
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)
0.234
(1.22, 25)
0.256
(−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)
0.003
(−3.34, 25)
0.611
(−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)
0.159
(−1.45, 25)
0.703
(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
Final
a
24.39 (9.19) 19.98 (9.58) 0.236
Thiamin (mg) Baseline
a
1.57 (1.02) 1.71 (1.01) 0.516 0.780 0.028
Final
a
1.60 (0.91) 1.36 (1.07) 0.472
Niacin equiv. (mg) Baseline
a
45.63 (15.11) 45.75 (17.78) 0.657 0.790 0.059
Final
a
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)
0.026
(2.36, 25)
0.006
(−3.06, 22)
Final 10.25 (5.07) 7.58 (3.07) 0.031
(2.23, 48)
Vitamin A equiv. (µg) Baseline
a
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
a
2079.47 (2928.79) 2277.76 (2486.46) 0.893 0.058 0.036
Final
a
2816.92 (3592.27) 1783.73 (1648.62) 0.021
Potassium (mg) Baseline
a
2768.52 (1112.38) 2880.05 (856.89) 0.494 0.144 0.042
Final
a
2781.36 (1077.97) 2616.96 (1357.54) 0.382
Iron (mg) Baseline
a
10.92 (5.31) 12.48 (5.01) 0.320 0.949 0.008
Final
a
11.42 (4.86) 10.84 (4.57) 0.567
LC n-3 (mg) Baseline
a
107.47 (155.75) 215.23 (334.95) 0.043 0.015 0.855
Final
a
151.54 (315.91) 181.78 (297.08) 0.712
α-Linolenic acid (g) Baseline
a
1.07 (0.70) 1.17 (0.56) 0.182 0.018 0.048
Final
a
1.27 (1.60) 1.02 (0.43) 0.014
Bold values indicate a statistically significant finding (p<0.05).
a
Non-parametric data presented as median (IQR).
b
P-values (t, df) for independent samples t-test (or Mann–Whitney U-test for non-parametric data) to compare difference between
ModiMedDiet intervention and control group.
c
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).
Opie et al. A modified Mediterranean dietary intervention for adults with major depression
Nutritional Neuroscience 2017
12
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specifically for the SMILES trial and based on existing
dietary guidelines and recommendations,
44
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
study.
58
Such differences are potentially explained
by the fact that participants enrolled in the SMILES
trial had poor quality diets at baseline,
25
which
were generalizable to the Australian population,
59
whereas the participants recruited for PREDIMED
were already following a ‘reasonably good’
Mediterranean-style food pattern.
58
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.
58
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
58
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 standard’measure.
60
Moreover, the data were examined by an RA or die-
titian for accuracy of reporting, and under- and over-
reporting
27
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.
61
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.
62
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,
63
monitoring, and social
support.
64
Conclusion
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
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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,
65
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,
21
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 Carman’s 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 O’Neil 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/
1028415X.2017.1312841.
ORCID
Felice N. Jacka http://orcid.org/0000-0002-9825-
0328
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