Lifestyle modification in the management of the metabolic syndrome: achievements and challenges

Abstract

Lifestyle modification based on behavior therapy is the most important and effective strategy to manage the metabolic syndrome. Modern lifestyle modification therapy combines specific recommendations on diet and exercise with behavioral and cognitive strategies. The intervention may be delivered face-to-face or in groups, or in groups combined with individual sessions. The main challenge of treatment is helping patients maintain healthy behavior changes in the long term. In the last few years, several strategies have been evaluated to improve the long-term effect of lifestyle modification. Promising results have been achieved by combining lifestyle modification with pharmacotherapy, using meals replacement, setting higher physical activity goals, and long-term care. The key role of cognitive processes in the success/failure of weight loss and maintenance suggests that new cognitive procedures and strategies should be included in the traditional lifestyle modification interventions, in order to help patients build a mind-set favoring long-term lifestyle changes. These new strategies raise optimistic expectations for an effective treatment of metabolic syndrome with lifestyle modifications, provided public health programs to change the environment where patients live support them.

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DOI: 10.2147/DMSOTT.S13860
Lifestyle modication in the management
of the metabolic syndrome: achievements
and challenges
Riccardo Dalle Grave1
Simona Calugi1
Elena Centis2
Rebecca Marzocchi2
Marwan El Ghoch1
Giulio Marchesini2
1Department of Eating & Weight
Disorder, Villa Garda Hospital,
Garda (VR), Italy; 2Unit of Metabolic
Diseases & Clinical Dietetics, Alma
Mater Studiorum – University of
Bologna, Bologna, Italy
Correspondence: Giulio Marchesini
Unit of Metabolic Diseases & Clinical
Dietetics, Alma Mater Studiorum –
University of Bologna, Policlinico Via
Massarenti, 9, I-40138 Bologna, Italy
Tel +39 051 6364889
Fax +39 051 6364502
Email giulio.marchesini@unibo.it
Abstract: Lifestyle modification based on behavior therapy is the most important and effective
strategy to manage the metabolic syndrome. Modern lifestyle modification therapy combines
specific recommendations on diet and exercise with behavioral and cognitive strategies. The
intervention may be delivered face-to-face or in groups, or in groups combined with individual
sessions. The main challenge of treatment is helping patients maintain healthy behavior changes
in the long term. In the last few years, several strategies have been evaluated to improve the
long-term effect of lifestyle modification. Promising results have been achieved by combining
lifestyle modification with pharmacotherapy, using meals replacement, setting higher physical
activity goals, and long-term care. The key role of cognitive processes in the success/failure of
weight loss and maintenance suggests that new cognitive procedures and strategies should be
included in the traditional lifestyle modification interventions, in order to help patients build a
mind-set favoring long-term lifestyle changes. These new strategies raise optimistic expectations
for an effective treatment of metabolic syndrome with lifestyle modifications, provided public
health programs to change the environment where patients live support them.
Keywords: metabolic syndrome, obesity, lifestyle modification, cognitive behavior therapy
Introduction
The metabolic syndrome (MS) is a clinical condition characterized by a cluster of
abnormalities, including visceral obesity, hyperinsulinemia and insulin resistance,1
type 2 diabetes, dyslipidemia, hypertension, fatty liver, and elevated uric acid, a
procoagulant state, whose borders are only provisionally set by different international
agencies (Table 1).2–5 The focus is given to visceral obesity,6 which is considered the
pivotal alteration according to the International Diabetes Federation,4 and to atherogenic
dyslipidemia, which covers two of the five diagnostic criteria. The prevalence of MS
is increasing worldwide in parallel with the alarming rise of obesity;7 according to
the National Health and Nutrition Examination Survey, MS is estimated to affect up
to 36% of the US adult population,8 with a lower prevalence in Europe.9 Although the
accepted cutoffs of individual variables do not constitute per se evidence of risk factors,
the clustering of abnormalities carries a high risk of the diabetes and cardiovascular
diseases. In particular, the presence of MS is associated with a two- to four-fold increase
of cardiovascular disease-related morbidity and mortality,10,11 even in the absence of
clinically evident cardiovascular disease or diabetes mellitus.12,13
MS affects people whose excess weight and sedentary life determine the
phenotypical expression of a genetically acquired trait. The balance between genes
and environment in disease expression is variable, but maintaining normal weight
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Table 1 Diagnostic criteria of the MS, according to the most popular proposals (National Cholesterol Education Program, International
Diabetes Federation, and the Joint Interim Statement of several International Associations and Agencies)
Criteria for diagnosis NCEP (ATP-III)2IDF4Joint Interim Statement5
Any three of the
following
Visceral obesity + two
of the remaining
Any three of the
following
Visceral obesity Waist circumference .102 cm (M)
or .88 cm (F)
Waist circumference $94 cm
(M) or $88 cm (F)a
Waist circumference $94 cm
(M) or $88 cm (F)a
Atherogenic dyslipidemia HDL-Chol ,40 mg/dL (M)
or ,50 mg/dL (F)
HDL-Chol ,40 mg/dL (M)
or ,50 mg/dL (F)
HDL-Chol ,40 mg/dL (M)
or ,50 mg/dL (F)
Triglycerides $150 mg/dL
or drug-treated
Triglycerides $150 mg/dL
or drug-treated
Triglycerides $150 mg/dL
or drug-treated
Altered glucose regulation Blood glucose $110 mg/dL
or treated for diabetesb
Blood glucose $100 mg/dL
or treated for diabetes
Blood glucose $100 mg/dL
or treated for diabetes
Elevated arterial pressure Arterial pressure $130/85 mmHg
or treated for hypertension
Arterial pressure $130/85 mmHg
or treated for hypertension
Arterial pressure $130/85
mmHg or treated for hypertension
Notes: aThese cutoffs are valid for Caucasians. Different cutoffs are reported for individuals of different ethnic origin; bLater reduced to 110 mg/dL.
Abbreviations: NCEP, National Cholesterol Education Program; IDF, International Diabetes Federation; ATP-III, Adult Treatment Panel III.
and practicing physical activity remain the primary and
most effective prevention strategy.14 Similarly, treatment
should be based on the promotion of effective weight loss
and physical exercise, but attempts at engaging patients
in healthy lifestyles and at maintaining the results require
specific strategies.14 Patients’ adherence to nutritional pre-
scription and motivation to practice daily physical activity
progressively reduce in the course of time and with treatment
length,15 and metabolic improvements rapidly vanish with
weight regain. Long-term lifestyle modification strategies
are necessary, and behavioral procedures represent the most
effective nonsurgical approach.16
In this article, we address the following topics: i) the
role of lifestyle modification in the management of MS,
ii) the principles and the main strategies of lifestyle modifi-
cations based on behavior therapy, and iii) the new frontiers
of lifestyle modification programs.
The role of lifestyle modication
in the management of MS
Weight reduction represents the principal goal of most inter-
vention studies on MS. There is complete agreement that
weight loss is associated with significant improvements in the
clinical abnormalities of MS, including blood glucose, lipid
profile, and blood pressure,17,18 and even a moderate weight
loss (7% reduction) in 4 weeks can improve the metabolic
profile, despite the persistence of a high body mass index
(BMI).19 However, the greater the BMI loss, the larger are
the metabolic improvements.
In a 2-year study, 41 obese patients were assigned to a
long-term diet and lifestyle modification therapy.20 Two-thirds
of patients who achieved a weight loss of 10% or more did
no longer meet the diagnostic criteria of MS, whereas in
patients who lost ,10%, the prevalence of MS remained
high (81%).
Lifestyle modifications are also desirable in subjects
who have only one or two criteria of MS, not the full-blown
disorder. In the large US Diabetes Prevention Program
(DPP), the effects of lifestyle intervention have been inves-
tigated in more than 3000 participants with impaired glucose
tolerance.21 The patients in the intervention group were
allocated to an intensive lifestyle intervention (including
a low-calorie, low-fat diet and weight loss) or to the met-
formin therapy (850 mg three times daily.). MS incidence
was reduced by 41% in the lifestyle group (P , 0.001) and
by 17% in the metformin group (P = 0.03) compared with
the placebo arm. Among participants who already met the
criteria for MS at baseline, 38% in the lifestyle group, 23%
in the metformin group, and 18% in the placebo group no
longer had the syndrome after a mean follow-up of 3.2 years.
This demonstrates that lifestyle changes can, by themselves,
reverse the metabolic abnormalities of MS. Similarly, the
effects of lifestyle modification have been measured in the
Finnish Diabetes Prevention Study.22 A cohort of 522 middle-
aged, overweight subjects with impaired glucose tolerance
was randomized either to a usual care control group or to
an intensive lifestyle intervention group. The control group
received general dietary and exercise advice at baseline
and had a yearly medical examination. The subjects in the
intervention group received additional individualized dietary
counseling from a nutritionist. They were also offered circuit-
type resistance training sessions and advised to increase
overall physical activity. After 3 years, the intervention
produced significantly larger effects on weight loss, dietary

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Lifestyle modication in MS
fat intake, moderate-to-severe leisure time physical activity,
fasting glucose and lipid concentrations,22 and the incidence
of diabetes was significantly reduced in comparison to
controls (11% versus 23%, P , 0.001).23 The intervention
program was more intensive during the first year, when the
changes in clinical characteristics were particularly large. In
a secondary analysis,24 after a mean follow-up of 3.9 years,
the intervention group reached a significant reduction in
the prevalence of MS and visceral obesity compared to the
control group. When compared to the results of the DPP
study, in the Diabetes Prevention Study, the prevalence of
MS in the control group tended to be lower, indicating that
the ‘mini-intervention’ carried out in the control arm had
some effect on the occurrence of MS.
In addition, the macronutrient composition of diet, not
only the caloric deficit, may be important in the management
of MS. In the SUN prospective cohort,25 a Mediterranean-style
diet (high consumption of fruit, vegetables, legumes, grain,
moderate alcohol intake, a moderate-to-low consumption of
dairy products and meats/meat products, and a high monoun-
saturated-to-saturated fat ratio) was inversely associated with
the cumulative incidence of MS. In the PREMIER study,26
the Dietary Approaches to Stop Hypertension diet (rich in
fruit, vegetables, and low-fat dairy foods, and low in saturated
and total fat intake) plus lifestyle interventions improved the
metabolic parameters, particularly blood pressure.
In the treatment of MS, physical activity has a pivotal
role. Cardiorespiratory fitness was reported to modulate
the relationship between MS and fatal events, providing a
strong protective effect against all-cause and cardiovascular
mortality.27,28 The amount and the intensity of physical
exercise regulated the circulating levels of lipids and other
metabolic abnormalities responsible for cardiovascular risk.29
When combined with diet, physical activity exerted a greater
effect compared with studies where either approach is prac-
ticed alone.30 In particular, adding aerobic exercise training to
nutritional weight-reducing approach resulted in many more
cases resolving (95% versus 75%) or improving (adjusted
odds ratio, 3.68) MS compared to diet alone.31
The intensity of physical activity required to improve
metabolic parameters is not defined. Even a low-intensity exer-
cise training for a 2-month period improved some metabolic
abnormalities,32 but an exercise dose–response was reported
on the components of MS.33 Several studies confirmed that
higher levels of physical activity are associated with lower
prevalence and incidence of MS and cardiovascular risk fac-
tors in cross-sectional and prospective studies.34–36 In a recent
analysis of the National Health and Nutrition Examination
Survey data,37 maintaining an active lifestyle, as assessed by the
number of daily steps measured by an accelerometer, reduced
the prevalence of MS and cardiovascular risk factors.
In summary, lifestyle modification programs are neces-
sary to maintain metabolic changes in the long period, and
such programs should always address both nutritional treat-
ment and physical activity.38,39
Principles and main strategies of
lifestyle modications based
on behavior therapy
Behavior therapy has been designed to provide patients with
a set of principles and techniques to modify their eating and
activity habits.40 Originally, the treatment was exclusively
based on the learning theory (ie, behaviorism). The theory
postulates that the behaviors causing obesity (excess eating
and low exercising) are largely learnt and therefore could
be modified or relearnt.41–43 The theory also postulated that
positive changes in eating and exercising can be achieved
by modifying the environmental cues (antecedents) and the
reinforcements of these behaviors (consequences).43 The
intervention was later integrated with cognitive strategies
(eg, problem solving and cognitive restructuring) and with
specific recommendations on diet and exercise.44 The treat-
ment is different from typical psychotherapy. The aim is not
to treat a psychiatric disorder, but rather to change eating and
exercise behaviors. In addition, lifestyle intervention does
not address the potential causes of the problematic behaviors,
but it is focused to teach skills to change them.40
How to deliver lifestyle modication
treatment
In research settings, lifestyle modification treatments have
been delivered in individual sessions (as was in the DPP)45
or in groups of ∼10–20 participants46 or in groups combined
with individual sessions (as in the Look AHEAD study).47
Outside research settings, lifestyle modification treatment
should be delivered by a multidisciplinary team composed
of physicians and nonphysician health professionals, such as
dieticians or professionals with a master degree in exercise
physiology, behavioral psychology, or health education.48
Within these multidisciplinary teams, physicians should
limit their intervention to the initial assessment, the manage-
ment of medical complication, the engagement in lifestyle
modification treatment, and in a periodic medical evaluation;
nonphysician health professionals should be actively involved
in the delivery of lifestyle modification treatment.

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Dalle Grave et al
Although both individual and group treatment strategies
are effective, a study found that participants who were ran-
domized to receive group-based therapy lost significantly
more weight than those who were treated individually.49
Despite the benefits of group treatment, several clinicians
believe that individual contact is critical to keep patients
in long-term treatment.47 The development of a trusting
relationship between clinicians and patients is consid-
ered as a safety net for participants who stop attending
group sessions regularly, a common event after the first
6–12 months.50,51
Frequency and duration of lifestyle
modication treatment
Lifestyle modification programs generally offer patients
with obesity an intensive first phase, consisting of 16–26
weekly sessions.46,52 After 6 months, weight loss tends to
reach a plateau, irrespective of treatment strategies, exclud-
ing bariatric surgery,52,53 and weekly treatment of up to
1 year produces only marginally greater weight loss than
that achieved in 6 months.54 Unfortunately, no definite data
are available about the optimal duration and intensity of the
weight maintenance phase. A few studies showed that group
sessions delivered twice a month for 1 year after the weight
loss phase facilitated the weight loss maintenance, while
retaining patients in active treatment.52,55 However, continu-
ous care up to 3 years produced long-term weight loss only in
a subgroup of obese patients and was associated with a high
rate of attrition.56 With too intensive models, most patients
tend to experience therapy ‘burnout’,54 particularly when
they reach the weight loss plateau, and monotonous sessions
favor the discontinuation of treatment.46 Noteworthy, not all
dropouts should be considered treatment failures. Patients
satisfied with the results obtained with treatment and those
who were confident to lose additional weight without pro-
fessional help were shown to maintain an even larger mean
weight loss than continuers.56
Strategies to engage patients
in lifestyle modication
Some of the key principles and strategies to engage patients
in lifestyle modification, derived from motivational
interviewing,57,58 are listed below:
• Conceptualization of motivation. Motivation is a dynamic
entity waxing and waning as a function of shifting per-
sonal, cognitive, behavioral, and environmental deter-
minants.59 This means that patients’ motivation may
require continuous attention, not only during the engaging
process, but also in the course of treatment.60
• Collaborative therapeutic style. Clinicians should adopt
a collaborative therapeutic style as opposed to a confron-
tational approach.61 The collaborative style of cognitive
behavior therapy has been considered as one of the main
reasons for its higher success compared to other interven-
tions to engage patients with resistance.62
• Acceptance and change. Clinicians should validate
patients’ experience within the framework of a bal-
ance between acceptance and change, firmness, and
empathy.63
• Functional analysis. Clinicians should make a functional
analysis of the pros and cons of changing lifestyle because
change is facilitated by communicating in a way that
elicits the person’s own reasons for and the advantages
of change.57
• Roll with resistance. Clinicians should not address
resistance with confrontation, but with a collaborative
evaluation of the variables involved in maintaining the
unhealthy lifestyle.57
• Support self-efficacy. Self-efficacy refers to a person’s
belief that he/she is capable of keeping a specific
behavior;64 it plays an important role in achieving health
behavior change.65 In the evaluation interview, clini-
cians should promote self-efficacy by raising the hope
that lifestyle changes can be attained. Later, during the
program, self-efficacy should be promoted by designing
an individualized eating and physical activity program
that patients are confident to stick to.66
• Be sensitive to stigma against individuals with obesity.
Stigma influences the decision of patients with obesity
to start treatment.67 To prevent stigma, clinicians should
recognize that obesity and MS are medical conditions and
not the product of lack of willpower and treat patients
with respect and support.67
• Educate patients. Clinicians should inform patients of the
negative aspects of unhealthy lifestyles and the benefits of
engaging in healthy behavior on the management of MS.
Table 2 shows the main topics to cover when educating
patients on MS and lifestyle modification. A strategy to
promote patients’ engagement in treatment is also giving
detailed information about aims, duration, organization
procedures, and the results of lifestyle modification, using
written material.16 In reluctant patients, it might be helpful
to propose treatment as a sort of experiment, with a possible
return to the old habits in the absence of benefits.68

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Lifestyle modication in MS
Table 3 Practical recommendations for diet and physical exercise
in lifestyle modication programs
Dietary recommendations16
1000–1200 kcal/day for overweight women, and 1200–1600 kcal/day for
overweight men and heavier for more active women
The diet should provide $55% calories from carbohydrates, #30% from
lipids (7%–10% from saturated fats), and ∼15% from proteins
Total calories should be moderately increased according to the daily
amount of physical activity
Diets are designed to create a calorie decit of 500–1000 kcal/day,
producing a weight loss of 0.5–1.0 kg/week
Physical exercise recommendations77
Engage in moderate-to-vigorous exercise for at least 60 min on most
days (at least 5 days/week)
Walking may be the favorite exercise, as unstructured exercise may be
included in routine daily activities
Check the baseline number of steps by a pedometer, then add 500 steps
at 3-day intervals to a target value of 10,000–12,000 steps/day
Jogging (20–40 min/day), biking, or swimming (45–60 min/day) may
replace walking
Physical exercise is intended to produce a calorie decit of at least
400 kcal/day, favoring weight loss, maintaining muscle mass, and
preventing weight cycling
Notes: The aim of behavior therapy is to provide patients with cognitive and
behavioral skills to modify their lifestyle. Accordingly, these recommendations should
not be intended as prescriptions, but should be tailored on patients’ preferences.
Table 2 Main topics to cover when educating patients on MS and
on lifestyle modication
1. Denition and diagnosis
The MS is a cluster of conditions that increase the risk of developing
vascular disease (heart disease, strokes, and peripheral vascular disease)
For diagnosis, see Table 1
2. Prevalence
MS affects up to 25% of the population in the United States7 and 15% of
the population in Europe9
It increases with age (,10% in individuals aged 20–29, 20% in individuals
aged 40–49, and 45% in individuals aged 60–69)7
The ‘obesity epidemic’ is considered the main factor responsible for the
increasing prevalence of MS6
3. Causes
It is linked to insulin resistance.1 The causes of insulin resistance have
not yet been completely claried. It probably involves a variety of
genetic and environmental factors. Both being overweight and inactive
contribute to the disease state
4. Consequences
MS increases the risk of developing type 2 diabetes11 and CVD and the
risk for CVD mortality10
Other conditions that are associated with MS are, notably, polycystic
ovary syndrome, fatty liver, cholesterol, gallstones, asthma, sleep
disturbances, and some forms of cancer6
5. Management
Weight loss with lifestyle modication (hypocaloric diet, increased
physical activity, and cognitive behavior therapy to help patients modify
eating and activity habits) is the key procedure to manage MS.2 Research
data indicate that a lifestyle intervention produce a marked reduction in
the prevalence of MS and a decline of body weight, waist circumference,
fasting glucose, triglycerides, and blood pressure.21 The treatment may
be delivered in groups and/or individually by a multidisciplinary team
trained in lifestyle modication, which includes a registered dietitian,
a behavioral psychologist, and an exercise specialist, coordinated by a
physician. It includes weekly sessions for the rst 6 months, followed by
two sessions a month in the following 6 months
Specic treatment of lipid (eg, hypertriglyceridemia) and nonlipid risk
factors (eg, hypertension and hyperlycemia) may be added to the lifestyle
modication2
Abbreviation: CVD, cardiovascular disease.
Dietary recommendations
Lifestyle modification programs recommend a low-calorie
diet, and their basic principles are reported in Table 3.16 Diets
are intended to induce a caloric deficit of 500–1000 kcal/
day, and able to promote a weight loss of 0.5–1.0 kg/week.
Very-low-calorie diets, with a calorie content #800 kcal/
day, are no longer recommended because, despite producing
greater initial weight losses, they require medical monitoring
and nutritional supplementation and have no advantages on
long-term weight loss.50 Recently, several randomized con-
trolled trials found that low-carbohydrate diets (ie, ,30 g/
day) produced greater initial weight reductions than the more
traditional low-calorie diets (∼1000–1200 kcal/day) described
in Table 3.69–71 However, weight loss, metabolic outcomes,
and dietary intake are no longer different after 36 months.72
These data indicate that the real problem to face with dietary
recommendation is not to identify the optimum macronutri-
ent composition but the adherence to dietary modification in
the long term.
Adherence may be enhanced by increasing diet struc-
ture and limiting food choices, thereby reducing temptation
and the potential mistakes on calculating energy intake.40
A strategy to increase the diet structure is to provide patients
with meal plans, grocery lists, menus, and recipes.73 Support
for this strategy derives from a study showing that the provi-
sion of both low-calorie food (free of charge or subsidized)
and structured meal plans resulted in significantly greater
weight loss than a diet with no additional structure.73
Another effective strategy to increase dietary adherence is
meal replacements. A meta-analysis of six controlled trials found
that liquid meal replacement determines a 3-kg greater weight
loss than that produced by conventional diets.74 Meal replace-
ment helps patients overcome some problems that occur when
consuming conventional food diets (ie, underestimation of calo-
rie intake, difficulties in estimating portion sizes, macronutrient
composition, calorie content, and in recalling the consumed
food), and simplify food choices.46 The use of portion-controlled
servings of conventional food is another effective strategy to
facilitate dietary adherence and weight loss.75,76

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Exercise recommendations
An initial assessment is needed to determine the current
level of physical activity in individual patients. It is clinically
useful to start asking patients how they judge their present
level of physical activity and whether they believe that it is
adequate to lose or maintain body weight. If, as usual, patients
report to be sedentary, the following step is asking why and
whether there are physical or logistical barriers to exercise
(eg, arthritis and time constraints).
Clinicians should evaluate which type of activity is
feasible for patients, considering the barriers (see above)
that can prevent a successful increase in physical activity.
Accordingly, they should assist patients in developing a
physical activity plan based on the initial assessment. Any
type of physical activity should be encouraged.
Lifestyle modification programs recommend a moder-
ate-to-vigorous exercise for at least 60 min on most days
(Table 3).51,77 Lifestyle activity should be increased slowly
in intensity and duration (by 5 min/session/week), starting
from a low-intensity exercise (∼3 metabolic equivalent)
in sedentary subjects, to avoid excessive fatigue, muscle
pain, strains, or injuries.45,47 Patients should be encouraged
to register their baseline physical activity or to check their
baseline number of steps by a pedometer. Whenever brisk
walking is chosen as the preferred activity, they should be
instructed to add 500 steps at 3-day intervals to a target
value of 10,000–12,000 steps/day.16,78 Although aerobic exer-
cise may be considered as the preferred activity, resistance
exercise and strength training should also be considered
as effective options according to individual preferences.
The presence of medical comorbidities (eg, hypertension,
cardiovascular disease, MS, and diabetes) could contraindi-
cate strength training and may indicate additional medical
workup, including exercise testing and/or appropriate medi-
cal supervision during exercise.
Exercise adherence, contrary to dietary adherence,
increases with less structure.40 For example, patients engage
in more physical activity when instructed to do so on their
own at home than when asked to attend on-site, supervised,
group-based exercise sessions.79 In addition, increasing
lifestyle activity (eg, using stairs rather than elevators,
walking rather than riding or using the car, and reducing
the use of labor-saving devices) determines similar weight
loss, but greater weight maintenance than structured, pro-
grammed activity.80–82 Finally, prescribing multiple short
bouts (10 min each) rather than one long session may help
patients accumulate more minutes of exercise. In summary,
these data suggest that decreasing the structure of exercising
probably reduces those barriers that inhibit exercise (eg, lack
of time or financial resources).40
Behavioral procedures
Self-monitoring
The core procedure of the lifestyle modification treatment is
based on self-monitoring of food intake, physical activity,
and body weight;83 the larger the use of self-monitoring, the
larger the amount of weight loss.84
Patients seeking to lose weight, in particular those who
report difficulties in losing weight, underestimate their
calorie intake by almost 50%.85 It is, therefore, essential to
help patients improve their ability in estimating food intake
by using measurement tools (such as cups, spoons, and food
scales) and nutrition fact labels and manuals with the calorie
content of food.40 Practical in-session exercises are useful for
this purpose. Patients are invited to register, in a monitoring
sheet, the time, the amount, the type, and the calorie content
of the food and beverages they are planning to consume and
later check during meals if they respect their plans. Any
change should be noted in the food diary, and the amount of
calorie intake should be recalculated. ‘Real time’ monitoring
is a strategy that may help patients interrupt behaviors that
are automatic and out of control.86
Physical activity can be recorded on the same monitor-
ing sheet in minutes (of programmed activity) and/or steps
(of lifestyle activity), using a pedometer, with the intent
to reach at least 10,000 steps/day.40 Patients interested in
having a more precise measurement of their daily energy
expenditure may use an accelerometer, which measures total
expenditure, the energy expenditure in physical activity, the
duration and the levels (in metabolic equivalent of task) of
physical activity and sleeping time.
Patients may also benef it from recording activities,
moods, and thoughts associated with eating and exercising.
This information may help identify obstacles to behavior
change. Self-monitoring records can also be used to provide
information to identify contingencies that can be targeted
for intervention.40
Patients are also encouraged to check their weight regu-
larly (eg, once a week), because frequent checking of weight
is associated with better long-term weight maintenance,87 and
to record their weight in a weight graph to assess their weight
trend. Patients are encouraged to discuss the interpretation of
weight change with their therapists during the group or the
individual sessions. The weighing procedure has a number

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Lifestyle modication in MS
of purposes. First, it provides a good opportunity to educate
patients about their weight, about body weight in general, and
how to interpret the number on the scales, which otherwise
they are prone to misinterpret. It is important to educate
patients that each reading is subjected to error, mainly due to
variation in the hydration state. For this reason, they need to
focus on what happened over the past 4 weeks to distinguish
weight changes from natural fluctuations. Second, weighing
stimulates patients to maintain a lifestyle oriented to weight
control. Third, regular weighing may help patients address
two problematic behaviors with a negative influence on
lifestyle modification adherence: excessive weight checking
and avoidance of weight checking.83 Patients with excessive
weight checking (eg, several times a day) may reduce their
effort to maintain a lifestyle focused on weight control if they
misinterpret insignificant day-to-day weight oscillation as
an increase. On the other hand, weight checking avoidance
makes it impossible to test weight changes.
Goal setting
Patients entering lifestyle modification programs are encour-
aged to set specific and quantifiable weekly goals (ie, increasing
physical activity by 1000 steps/week or eating only at meals),
which should be realistic and moderately challenging.40 Goal
achievement is associated with a sense of accomplishment,
which is reinforcing and enhances self-efficacy,48 a construct
associated with long-term weight loss.56
Particular attention should be paid to patients’ weight
loss expectation, since higher weight loss expectations are
associated with attrition.88 A few data indicate that encour-
aging participants to seek only a modest initial weight loss
does not facilitate weight maintenance and produces a lower
weight loss than standard treatment.89 In the initial phase of
treatment, it is more useful to have patients focus on weekly
weight loss (eg, losing from ½ to 1 kg per week) and to
detect and promptly address any warning sign of weight loss
dissatisfaction, thus minimizing the risk of attrition.88 In our
clinical experience, unrealistic weight loss expectations may
be easily changed later when patients have reached some
intermediate goals and the rate of weight loss is declining.
Specific strategies to change weight goals have been recently
described in the modern cognitive behavioral treatments
of obesity.83 A crucial aspect favoring the modification of
unrealistic weight goals is the development of a trusting and
collaborative clinician-to-patient relationship.88 This is also
a key factor to avoid the sense of abandonment that patients
report as one of the main reasons of attrition.90
Stimulus control
These procedures are based on the principles of classical and
operant conditioning. Stimulus control is aimed at modifying
the environment (ie, external eating cues) to make it more con-
ductive to choices supporting changes in eating and exercising.
Patients should be instructed both to remove triggers of
excessive eating (eg, keeping tempting food out of sight or
avoiding buying it) and to increase positive cues for exercis-
ing (eg, lay out exercise clothes before going to bed) and for
desirable behavior (eg, putting the food sheet on the table to
facilitate its real-time compilation during eating). Stimulus
control may also be used to reinforce the adherence to eating
control and exercising by establishing a reward system (eg,
encouraging patients to set weekly behavioral goals and to
reward themselves in case of achievement, but not through
food or inactivity).40 Encouraging patients to use cognitive
rewards (eg, ‘I’ve been OK,’ ‘I’m doing great,’ and ‘I have the
ability to lose weight and to have an active lifestyle’) once they
reach their lifestyle goals it may also help patients reduce their
frustration associated with limited weight loss and strengthen
their confidence in controlling body weight and maintaining
a healthy lifestyle. Positive reinforcements may also be used
by clinicians, who should congratulate the patients on every
success they achieve and should never criticize failures.91
Criticism may produce guilt and loss of self-confidence,
leading to attrition. An unconditional acceptance of patients’
behavior and a problem-solving approach to cope with barriers
will preserve the clinician–patient relationship. This approach
will also help patients understand that the long-term success
in weight management is related to a set of skills rather than
to willpower.
Stimulus control may also be facilitated by the involve-
ment of significant others.92 With the consent of patients,
clinicians should involve significant others in the treatment
program to create the ‘optimum’ environment for patients’
change. The needs vary from patient to patient, but generally
include planning together a written shopping list, eating the
same foods, exercising together, creating a relaxed environ-
ment, and reinforcing patients’ positive behaviors.
Alternative behaviors
This procedure is used to manage internal eating cues
(eg, emotional stimuli). Patients are trained to identify these
cues and to replace eating cues with alternative behaviors.
Any alternative behavior works better if it is incompatible
with eating (eg, writing, knitting, housekeeping, exercising,
and taking a bath). Other behaviors (eg, listening to music or

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Dalle Grave et al
reading) might not be appropriate, as people can easily eat
and listen to music or read a book simultaneously.40
Cognitive procedures
Proactive problem solving
Proactive problem solving is used to address events that hinder
lifestyle weight control adherence. The typical problem-
solving approach includes five steps.93 Step 1 encourages
patients to detail the problem and the chain of events (ie,
situations) that preceded the problem. Step 2 helps patients
brainstorm any possible solution. Step 3 suggests patients list
the pros and cons for each potential solution. In step 4, patients
should choose the best option on the basis of the previous anal-
yses to be implemented for a fixed amount of time. Finally,
during step 5, the patients evaluate the results achieved. If the
solution fails, the process should be repeated.
Initially, it is recommended to practice problem solving
in the session with the clinician, encouraging the patient to
take the lead whenever possible. As homework, patients
should be asked to practice their own problem-solving skills,
looking out for events that would be liable to trigger changes
in their eating or exercising and addressing them using the
problem-solving procedure. Specifically, once patients iden-
tify a problem, they should write ‘Problem’ in the right-hand
column of the monitoring record sheet and then turn the
sheet over and write out the problem-solving steps. Patients
should be advised against solving the problem mentally, as
this is much less effective. The emphasis should be on help-
ing patients acquire the ability to address or forestall events
that would otherwise trigger changes in eating or exercising.
As it is important that problems are spotted early, patients
should be encouraged to screen in advance for problems they
will meet during the week. In this way, their problem solving
becomes ‘proactive.’86
Cognitive restructuring
Cognitive restructuring is a technique used to help patients
identify dysfunctional thoughts and cognitive distortions that
interfere with their ability to maintain a lifestyle aimed at weight
control and to replace them with more functional ones (see
Figure 1).94,95 All-or-nothing thinking, in particular with regard
to success or failure, is a common cognitive bias observed
in patients during weight loss.40 In addition, for this activity,
patients are recommended to practice cognitive restructuring
during a session with therapists. Later, clinicians should give
patients homework to practice cognitive restructuring every
time they notice a tendency to decrease their efforts in lifestyle
modification as a consequence of an event. Specifically, when
patients identify a dysfunctional thought, they should write
‘Dysfunctional thoughts’ in the right-hand column of their
monitoring sheet and then turn the sheet over and address it by
writing out the cognitive restructuring steps (see Figure 1).
New frontiers of lifestyle
modication programs
At 3- to 5-year follow-up, 70%–80% of patients treated with
lifestyle modification regained all the weight they had lost.96,97
These data underline the fact that the major problem of lifestyle
modification treatment is weight loss maintenance in the long
term. Unfortunately, the mechanisms accounting for weight
regain have not been completely understood yet, but they seem
extremely complex, including biological, social, behavioral,
(A) Event
Gained 1/2 kg this week
(B) Dysfunctional thoughts (B) Functional thoughts
(C) Consequence (C) Consequence
“It is a failure; I will never be able to
lose weight. I had better give up trying
to lose weight”
“It is not a failure, but just a set back.
It is difficult to lose weight, but not
impossible: I’ve done it before”
Reduced efforts Increased efforts
Figure 1 An example of cognitive restructuring.
Notes: According to the cognitive model, the link between an activating event A) and the emotional or behavioral consequence C) is inuenced by the belief B) about the
activating event. When the belief contains cognitive bias (eg, as all-or-nothing thinking) as in the scenario on the left, the consequence tends to be unfavorable. However, if
the beliefs about that event have been adequately challenged and substituted with more functional thoughts, the consequences are more favorable (scenario on the right).94

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Lifestyle modication in MS
and cognitive factors. Nevertheless, the observation that at least
20% of patients maintain all the amount of weight loss at 4-year
follow-up98 indicates that weight loss maintenance is possible.
In this section, we discuss three potential areas of intervention
(biological, cognitive, and environmental) that might improve
the long-term maintenance of weight loss.
Combining lifestyle modication
with pharmacotherapy
One of the main factors implicated in the long-term failure
of weight maintenance is the biological pressure to weight
regain.99 It is, therefore, rational to evaluate the effect of com-
bining lifestyle modification with pharmacological therapies
aimed to mitigate the biological pressure to weight regain.
The available data suggest that this combined approach seems
to improve both the amount of weight loss and the mainte-
nance of weight lost.100 The enhancement of weight loss is
also associated with marked improvements in several meta-
bolic outcomes and risk factors of cardiovascular disease.101
Two medications – orlistat and sibutramine – are currently
approved in the United States for long-term weight loss.
A randomized controlled trial comparing the effects of life-
style modification and sibutramine (15 mg/day) either alone or in
combination found that there were no differences in weight loss
at 1-year weight for participants who received group-based life-
style modification alone versus those who received sibutramine
alone.100 However, participants treated with group-based lifestyle
modification and sibutramine achieved a 1-year weight loss
nearly twice as large as that of either therapy alone.100 These
data show that lifestyle modification and pharmacotherapy
are equivalent when used separately, but additive when used
in combination. Unfortunately, the preliminary analysis of the
Sibutramine Cardiovascular Outcomes Trial,102 which assessed
the safety of sibutramine in individuals with preexisting cardio-
vascular diseases or diabetes mellitus, showed a higher rate of
cardiovascular disease events in the sibutramine group compared
to placebo (11.4% versus 10.0%). On the basis of these results,
sibutramine was withdrawn from the European market in Janu-
ary 2010,103,104 but it is still available in the United States.
The XENDOS (Xenical in the Prevention of Diabetes
in Obese Subjects) randomly assigned 3305 participants to
lifestyle plus placebo intervention or lifestyle changes plus
orlistat who had a significant low cumulative incidence of type
2 diabetes and a greater weight loss than those treated only
with lifestyle modification.105 A few cases of serious adverse
hepatic effects (eg, cholestatic hepatitis and subacute liver fail-
ure) have been reported with the use of orlistat, prompting the
FDA to issue an update on the safety of orlistat in September
2009.106 However, the drug can be still prescribed and can be
also purchased over-the-counter at a lower dose (60 mg).
Some combination therapies targeting multiple
hypothalamic pathways that regulate appetite and body weight
are currently under investigation, but very few data have so far
been reported on their long-term safety and efficacy.107,108
Addressing cognitive processes
implicated in weight loss failure
The National Weight Control Registry (NWCR) has inten-
sively investigated individuals with long-term successful
weight loss.109 The participants registered in the NWCR must
have maintained a weight loss of $13.6 kg ($30 lb) for at
least 1 year, and on an average, they must have maintained a
32-kg (70 lb) weight loss for 6 years. The principal behaviors
reported by ∼3000 NWCR participants were:109–111 i) self-
monitoring of food intake and body weight (at least once a
week), ii) consuming a low-calorie (1300–1400 kcal/day) and
low-fat diet (20%–25% of daily energy intake from fat), iii)
eating breakfast every day, and iv) practicing regular physical
activity to expend 2500–3000 kcal/week (eg, walking 4 miles/
day). However, the research has not clarified yet why some
individuals stop practicing weight control behaviors after
losing weight, while others maintain them.
As cognitive processes are involved in the maintenance of
complex behaviors, such as eating and exercise, they are likely to
play a key role in the process of weight regain or maintenance,112
but have been scarcely evaluated by research.
The cognitive processes implicated in weight loss and
weight maintenance have been tested in the QUOVADIS
study, a large observational study on the quality of life
of obese patients seeking treatment at 25 medical centers
certified by the Italian Health Service for the treatment of
obesity.113 The study provided three main results. First, treat-
ment attrition was associated with higher weight loss expec-
tations.88 Second, the amount of weight loss was predicted
by increased dietary restraint and reduced dietary disinhi-
bition.114 Third, long-term weight maintenance (.3 years)
was observed in patients satisfied with the results achieved,
or confident to control their body weight without additional
professional help,56 a construct similar to the concept of
self-efficacy, which is associated with greater adherence
to physical therapy.115 These data suggest that including
specific strategies to address cognitive obstacles to weight
loss and weight maintenance could improve the long-term
effectiveness of lifestyle modification interventions.
Two books have been recently published with a major
focus on strategies addressing cognitive processes implicated

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Dalle Grave et al
in weight loss and maintenance,83,116 and some studies found
that adding cognitive procedures to lifestyle modification is
associated with better weight loss maintenance.117–121 However,
a recent randomized control trial failed to observe a positive
effect on long-term weight loss maintenance of a cognitive
behavior intervention specifically designed to address the
cognitive processes associated with weight regain.122
General strategies at population level
to facilitate lifestyle modication
Lifestyle modification might have more chance to be more
effective if supported by public health programs to change
the ‘toxic’ environment promoting overeating and sedentary
behaviors.123 Examples of a long list of possible interventions
aimed at improving the dietary and lifestyle habits of the
general population include i) modifying the urban design
and favoring physical activity in the community (parks,
sidewalks, and bike paths) and at school (physical fitness
curricula), ii) regulating the aggressive economic policies
promoting the purchase of processed foods, iii) increasing the
opportunities for family interaction (eg, family gathering at
meal time), iv) reducing the exposure of children to marketing
of energy-dense, micronutrient-poor foods, v) preventing the
collusion of schools in the sale of junk foods, vi) reducing
the portion of the meals served in the restaurant, vii) teaching
skills for preparing healthy food (implementing nutritional
standards for food in school, preschool, and after-school
programs; nutritional labeling of food; warning labels on
‘junk food’), and viii) favoring the access of low-income
ethnic and social groups to healthy food.124
Conclusions
Lifestyle modification plays a central role in the manage-
ment of MS. Programs based on lifestyle modification have
improved in the last few years; recent data show that a modest
long-term weight loss is associated with a marked reduction
of the incidence of type 2 diabetes125 and the prevalence of
MS.21 The promising results obtained with the inclusion of
innovative procedures, such as combining lifestyle modifi-
cation with pharmacotherapy,100 using meal replacement,74
setting higher physical activity goals,126 and long-term care,127
raise optimistic expectations for an effective treatment of
obesity and MS with lifestyle modifications.
More research is needed to understand the negative phenom-
enon of weight regain. The key role of cognitive processes in
the success/failure in weight loss and weight maintenance56,88,114
suggests that new cognitive procedures and strategies should
be included in the traditional lifestyle modification programs,
in order to help patients build a mind-set of long-term weight
control. Lifestyle modification programs will be more effective
if supported by public health programs to change the environ-
ment where patients live. Only through the synergy of individu-
als and a society global response, the maximum benefit for
patients with MS can be achieved, thus reducing the burden
of advanced disease and premature death.48
Finally, the positive results obtained by lifestyle modifi-
cation programs in the management of MS should stimulate
physicians to adopt a ‘team approach.’ General practitioners,
as well as physicians working in metabolic units and treat-
ing patients with MS, should receive adequate training in
cognitive behavioral therapy to engage patients in lifestyle
modification. Engaged patients should then be referred to
trained lifestyle counselors (eg, dieticians, psychologists,
physical activity supervisors, and case managers) working
closely with them, ideally in the same lifestyle modification
unit, to implement the full lifestyle modification program.
Acknowledgment
The research of GM has received funding from the European
Community’s Seventh Framework Program (FP7/2007–2013)
under grant agreement no. HEALTH-F2-2009-241762 for
the project FLIP.
Disclosure
The authors report no conflicts of interest in this work.
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