Cochrane Database of Systematic Reviews

Psychological interventions for adults who are overweight or

obese (Protocol)

Brennan L, Murphy KD, de la Piedad Garcia X, Ellis ME, Metzendorf MI, McKenzie JE

Brennan L, Murphy KD, de la Piedad Garcia X, Ellis ME, Metzendorf MI, McKenzie JE.
Psychological interventions for adults who are overweight or obese.
Cochrane Database of Systematic Reviews 2016, Issue 3. Art. No.: CD012114.
DOI: 10.1002/14651858.CD012114.

www.cochranelibrary.com

Psychological interventions for adults who are overweight or obese (Protocol)

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Psychological interventions for adults who are overweight or obese (Protocol) i

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Psychological interventions for adults who are overweight or

obese

Leah Brennan1 , Kylie D Murphy2 , Xochitl de la Piedad Garcia1 , Miriam E Ellis1 , Maria-Inti Metzendorf3 , Joanne E McKenzie4

1 School of Psychology, Australian Catholic University, Melbourne, Australia. 2 Centre for Obesity Research and Education, Monash
University, Melbourne, Australia. 3 Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Fac-
ulty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. 4 School of Public Health & Preventive Medicine, Monash
University, Melbourne, Australia

Contact address: Leah Brennan, School of Psychology, Australian Catholic University, The Daniel Mannix Building, Young Street,
Fitzroy, Melbourne, Victoria, 3065, Australia. leah.brennan@acu.edu.au. drleahbrennan@gmail.com.

Editorial group: Cochrane Metabolic and Endocrine Disorders Group.

Publication status and date: New, published in Issue 3, 2016.

Citation: Brennan L, Murphy KD, de la Piedad Garcia X, Ellis ME, Metzendorf MI, McKenzie JE. Psychological interven-
tions for adults who are overweight or obese. Cochrane Database of Systematic Reviews 2016, Issue 3. Art. No.: CD012114. DOI:
10.1002/14651858.CD012114.

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of psychological interventions for the treatment of overweight and obese adults. Specific objectives are to examine
the efficacy of:

1. All psychological therapies versus minimal or no intervention;

2. All psychological therapies versus an active diet and/or exercise intervention;

3. Behavioural psychological therapies (first, second or third wave) versus other psychological interventions.

Secondary objectives are to examine if the magnitude of intervention effects (objectives 1, 2, and 3) for the primary outcome of BMI
are modified by particular intervention characteristics (length of follow-up), or participant characteristics (degree of excess weight). We
also plan to investigate whether the effects of behavioural therapy are modified by the type of behaviour intervention (first, second or
third wave).

Overweight and obesity are defined as “conditions of abnormal

BACKGROUND
or excessive fat accumulation in adipose tissue, to the extent that
health may be impaired” (WHO 1998). These conditions are oper-
ationally defined as a body mass index (BMI), weight in kilograms
divided by the square of height in metres (kg/m²), of ≥ 25 kg/m²
Description of the condition
and ≥ 30 kg/m² respectively (WHO 1998). The World Health
Psychological interventions for adults who are overweight or obese (Protocol) 1
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Organization (WHO) estimates that in 2014, 39% of adults were
overweight (38% men and 40% women) and 13% were obese
(11% men and 15% women). Worldwide rates of overweight and
obesity in adults continue to rise. Rates of extreme obesity are
rising most quickly (WHO 2014). Although the prevalence of
overweight and obesity are highest in developed countries, rates
in developing countries are rising dramatically as income, urban-
isation, and processed food availability increase (WHO 2014).
In higher-income countries, obesity rates are highest among the
poor and those living in rural areas. In contrast, obesity rates in
lower-income countries are highest among those living in urban
and more affluent areas. The risk of obesity for women in low-
and lower-middle-income countries is almost double that of men.
Rates are similar for men and women in high-income countries
(WHO 2014).
Excess weight is associated with a range of negative biopsychoso-
cial outcomes; the higher the weight, the greater the risk. The
metabolic correlates of overweight and obesity include higher
blood pressure, raised cholesterol and triglycerides levels, and
greater insulin resistance. Consequently, overweight and obesity
are associated with increased risk of cardiovascular disease, type 2
diabetes mellitus, and some cancers (e.g., breast, colon, prostate).
Excess weight is also associated with a range of musculoskeletal,
respiratory, skin, and fertility conditions that impair health-related
quality of life (Guh 2009; WHO 2000; WHO 2014). Research
examining the psychosocial consequences of overweight and obe-
sity has focused almost exclusively on developed countries. Stud-
ies examining the psychological correlates of obesity in the com-
munity report mixed findings; however, on balance, they suggest
that women who are obese are vulnerable to symptoms of depres-
sion (including suicidal ideation) and low self-esteem (Luppino
2010). Results are more consistent in those seeking weight loss
treatment. Overweight and obese treatment-seekers demonstrate
higher rates of psychopathology, including mood disorders (de-
pression, low self-esteem, anxiety) and eating disorders (binge eat-
ing disorder, night eating syndrome, body image dissatisfaction),
as well as impaired health-related quality of life (Fontaine 2001; Jia
2005; Wadden 2002b). Heavier individuals are also at increased
risk of discrimination in employment, health care, education, the
media, and in interpersonal relationships (Puhl 2003). Combined,
these negative biopsychosocial outcomes result in significant im-
pairments in health-related quality of life (WHO estimates that
35.8 million (2.3%) of global disease-adjusted life years (DALYs)
are caused by overweight or obesity) and loss of productivity
(Fontaine 2001; Robroek 2010). Further, management of weight-
related comorbidities places a significant burden on healthcare sys-
tems (Colagiuri 2010; Hammond 2010; Müller-Riemenschneider
2008; Wang 2011; WHO 2000).
Traditionally, overweight and obesity were thought to be a conse-
quence of an individual’s poor health choices and behaviours re-
sulting in excess energy balance (Skender 1996; Spiegelman 2001).
Thus, early prevention and treatment efforts were targeted at in-
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
dividual behaviour change (Kremers 2010; Lemmens 2008; Shaw
2005; Shaw 2006; Thomas 2007). There is now improved under-
standing of the complexity of factors contributing to excess en-
ergy balance and weight gain. These include: individual and social
psychology, individual physical activity and the activity environ-
ment, food consumption and production, human and individ-
ual physiology (Vandenbroeck 2007). As a result of this improved
understanding, prevention and intervention efforts are changing
to encompass a wider range of contributing factors (Beauchamp
2014; Franz 2007; Kremers 2010; Lemmens 2008).
The high and increasing prevalence of overweight and obesity
highlights the need for prevention efforts. Despite considerable
research and intervention efforts targeting obesity prevention, the
rate of excess weight continues to rise. Successful prevention ef-
forts aim to first slow, then halt, then reverse increasing rates of
overweight and obesity. Therefore, overweight and obesity rates
will remain high for some time, even if prevention efforts are suc-
cessful. Thus, effective treatment approaches are required.
Description of the intervention
Overweight and obesity are treated using ’lifestyle’ (diet, exercise),
medical (pharmacological), and surgical interventions. Dietary in-
terventions targeting reduced energy and/or relative macronutri-
ent intake result in small weight losses in the short term with weight
typically regained in the longer term (Hession 2009; Thomas
2007). Very low energy diets result in larger weight losses, but
weight is typically regained (Franz 2007; Mann 2007). Exercise
interventions targeting increased energy expenditure via cardio-
vascular and/or resistance training result in small weight losses,
and result in marginal improvements in weight loss when com-
bined with dietary interventions (Jakicic 2001; Shaw 2006). A
number of pharmacological treatments have been shown to im-
prove weight loss outcomes (Franz 2007; Padwal 2003). However,
few are currently approved for use in the treatment of obesity. Al-
though surgical interventions are becoming increasingly popular
and produce the most substantial and sustained weight loss, they
also carry the most risk (Colquitt 2014).
While psychological interventions are often used in combination
with medical interventions (Douketis 2005), the majority of the
research examining psychological interventions examines these in-
terventions used in isolation or in combination with ’lifestyle’ in-
terventions (Sarwer 2014). A range of psychological interventions
has been used in the treatment of overweight and obesity. These
interventions have typically been adapted from those designed to
treat mental health conditions. The overarching objective of this
type of intervention is to reduce the psychological barriers to health
behaviour change (Shaw 2005). Which barriers are targeted, and
via which mechanisms, vary across types of psychological inter-
vention.
Treatment delivery settings (e.g., hospital, community), delivery
modes (e.g., face to face, telephone, online), delivery agent (e.g.,
2
psychologist, other health professional, lay person), and inten-
sity and duration, have varied considerably across these interven-
tions (Shaw 2005). Greater intensity and duration have resulted
in greater weight loss and weight maintenance respectively (Franz
2007). There are few other consistent findings regarding the im-
pact of these treatment characteristics on treatment outcomes.
How the intervention might work
Psychological interventions for overweight and obesity aim to re-
duce the psychological barriers to health behaviour change and
maintenance. The behavioural, cognitive, social and emotional
variables that are conceptualised as barriers and therefore targeted
in treatment vary depending on the theoretical underpinnings of
the intervention. The majority of psychological interventions for
overweight and obesity are cognitive behaviourally based, and are
typically used in combination with lifestyle interventions (Shaw
2005). There are three ’waves’ of cognitive behavioural interven-
tions. First wave or behaviour therapies target modification of the
behaviours and the antecedents and consequences hypothesised to
be maintaining a positive energy balance (Wadden 2002a; Wing
2001). Second wave or cognitive behaviour therapies target mod-
ification of the behaviours and thoughts hypothesised to be main-
taining a positive energy balance. Cognitive therapies target prob-
lematic thoughts hypothesised to be maintaining a positive energy
balance (Cooper 2004; Fabricatore 2007). Third wave cognitive
behaviour therapies are a family of interventions (e.g., meta-cogni-
tive therapy , acceptance and commitment therapy , mindfulness-
based cognitive therapy , dialectical behaviour therapy , and com-
passion-focused therapy targeting modification of both behaviours
and reactions to/relationships with thoughts hypothesised to be
maintaining a positive energy balance (Öst 2008).
A range of other psychological interventions has been used in
the treatment of overweight and obesity (Shaw 2005). These in-
clude relaxation therapy (Bertisch 2008), psychodynamic ther-
apy (Wiltink 2007), hypnotherapy (Kirsch 1995), eye movement
desensitisation and reprocessing (Stapleton 2011), emotion free-
dom techniques (Stapleton 2011), interpersonal psychotherapy
(Tanofsky-Kraff 2014), and emotion-focused therapy (Compare
2013). Unfortunately the mechanism of action of these interven-
tions in their treatment of obesity is not always explicitly and/or
consistently defined.
Adverse effects of the intervention
The potential adverse effects of obesity interventions have received
relatively little research attention (Shaw 2005; Shaw 2006). To
date, the biological impacts of weight loss have been shown to
be positive, demonstrating improvements in obesity-related dis-
ease risk factors (e.g., improved insulin resistance) in the short- to
medium-term (Shaw 2005). Similarly, participation in a weight
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
loss intervention has generally been shown to result in improve-
ments in psychological outcomes (e.g., depression, disordered eat-
ing) in the short- to medium-term (Hardeman 2000). Although
some studies have found that these improvements are related to
the amount of weight lost (Blaine 2007), others have attributed
improvements to other factors such as the social support received
while participating in a weight loss intervention (Elfhag 2005;
McLean 2003). Despite widespread recognition of the negative
social consequences of obesity (e.g., stigmatisation, discrimina-
tion), little is known about the effects of interventions on social
outcomes (Papadopoulos 2015; Puhl 2003).
Why it is important to do this review
The high and increasing prevalence of overweight and obesity
(WHO 2014), combined with the negative biopsychosocial co-
morbidities of excess weight (Guh 2009), and the limited effec-
tiveness of prevention efforts to date (Lau 2007; Lemmens 2008;
McTigure 2007; WHO 2000), highlight the need for effective
overweight and obesity treatment. There is now a large and in-
creasing body of evidence demonstrating the limited effectiveness
of lifestyle interventions in achieving substantial and sustained
weight loss (Shaw 2006; Wu 2009). In recognition of the chal-
lenges of achieving substantial and sustained weight loss, psy-
chological interventions increasingly are included in treatment
(Sarwer 2014; Shaw 2005).
The most recent Cochrane Review examining psychological inter-
ventions for overweight and obesity was published in 2005 (Shaw
2005). Over the last 10 years, the field has developed considerably
on three fronts. First, the last decade has seen the development
of ’third wave’ psychological interventions (Öst 2008). Second,
there has been a proliferation of research examining the efficacy,
and more recently, the effectiveness of psychological interventions,
particularly cognitive behavioural interventions (Hendrie 2012).
Third, this research has considered a broader range of biopsy-
chosocial outcomes and included longer follow-up periods (Blaine
2007). As a result, a new review would include a broader range
of psychological interventions and consider the impact of various
treatment characteristics on treatment outcomes more compre-
hensively. Furthermore, a review of current literature would also
help to clarify a series of inconsistent findings and interpretation of
findings that are present in the literature. Although there have been
a number of related systematic reviews of psychological interven-
tions for overweight and obesity conducted since 2005, they have
considered more specific questions such as methods of delivery of
intervention (i.e., web-based) (Neve 2010), specific populations
(e.g., disabled) (Hamilton 2007), or specific types of psychother-
apy (e.g., hypnosis) (Pittler 2005). Thus, there is a need for an
updated and comprehensive review of psychological interventions
for overweight and obesity.
3
OBJECTIVES
To assess the effects of psychological interventions for the treat-
ment of overweight and obese adults. Specific objectives are to
examine the efficacy of:
1. All psychological therapies versus minimal or no
intervention;
2. All psychological therapies versus an active diet and/or
exercise intervention;
3. Behavioural psychological therapies (first, second or third
wave) versus other psychological interventions.
Secondary objectives are to examine if the magnitude of interven-
tion effects (objectives 1, 2, and 3) for the primary outcome of BMI
are modified by particular intervention characteristics (length of
follow-up), or participant characteristics (degree of excess weight).
We also plan to investigate whether the effects of behavioural ther-
apy are modified by the type of behaviour intervention (first, sec-
ond or third wave).
METHODS
Criteria for considering studies for this review
Types of studies
We will include randomised controlled trials (RCTs), including
cluster randomised trials.
Types of participants
We will include trials of adult participants only (aged 18 to 65
years). Trials will include adults who are overweight or obese ac-
cording to any parameter (e.g. BMI, waist measurement, waist-
to-hip ratio). Over the years, the diagnostic criteria and classifica-
tion of obesity have changed several times (NHMRC 1997). To
be consistent with changes in classification and diagnostic criteria
of obesity over time, the diagnosis should have been established
using the standard criteria valid at the time the trial commenced.
Studies involving participants with comorbid physical or mental
disorders will be eligible for inclusion as long as the primary fo-
cus of the intervention is weight loss. Trials may be conducted in
primary care and community-based settings, or in secondary or
specialist settings and will include both professionally- and self-
referred participants.
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of interventions
All trials stating that they include a psychological intervention
will be included. There will be no restriction on who delivers the
intervention.
We plan to investigate the following comparisons of intervention
versus control/comparator.
Intervention: Objective 1 and 2
• Psychological intervention.
Comparator: Objective 1 and 2
• Minimal or no intervention.
• Active diet, exercise intervention or both.
Intervention: Objective 3
• Behavioural psychological therapies (first, second or third
wave)
Comparator: Objective 3
• Other psychological interventions.
Comparisons of psychotherapy as a supplementary therapy will
also be included if the additional effect of psychotherapy can be
determined (e.g. exercise plus psychotherapy versus psychother-
apy alone). Concomitant interventions will have to be the same
in both the intervention and comparator groups to establish fair
comparisons.
Minimum duration of intervention
We will define trial duration according to the number of months
over which the trial has been conducted and will only include trials
in the analyses with interventions that lasted longer than three
months. Trials in which the intervention was of less than three
months’ duration will be listed in an ’Additional table’ but not
included in analyses.
Exclusion criteria
• We will exclude trials in which the psychological
intervention was not delivered in a face-to-face format (at least
one face-to-face session) between the participant and therapist.
However,
we will include studies of interventions in which face-to-face ther-
apy is augmented by telephone- or Internet-based support.
• Psychological interventions delivered solely by
bibliotherapy, telephone or the Internet will be excluded.
4
 • We will exclude trials that combine a pharmacological Summary of findings
intervention, a surgical intervention or both with a psychological We will present a ’Summary of findings’ table to report the results
intervention. of the following outcomes, listed according to priority.
• Trials of interventions designed to prevent weight gain or to 1. BMI.
treat eating disorders will be excluded. 2. Weight.
• If multiple arms are included in a trial, any arm that meets 3. Cardiometabolic disease.
the inclusion criteria will be included in the review. 4. All-cause mortality.
5. Health-related quality of life.
6. Psychological factors.
Types of outcome measures
7. Adverse events.
To be included in the review, trials must have measured and re-
ported one or more of the primary or secondary outcome mea-
sures. We will contact authors to request data where outcomes
have been measured but not reported. Search methods for identification of studies

Primary outcomes
Electronic searches
• Body mass index (BMI).
We will search the following sources from inception of each
• Weight.
database to the specified date and will place no restrictions on the
• Adverse events.
language of publication.
• Cochrane Central Register of Controlled Trials
Secondary outcomes (CENTRAL).
• MEDLINE.
• Indicator of body mass other than BMI or weight.
• PubMed (subsets not available on Ovid).
• Cardiometabolic disease.
• PsycINFO.
• All-cause mortality.
• ClinicalTrials.gov.
• Health-related quality of life (HrQoL).
• World Health Organization (WHO) International Clinical
• Psychological factors.
Trials Registry Platform (ICTRP) Search Portal (http://
apps.who.int/trialsearch/), including:
Method and timing of outcome measurement ◦ Australian New Zealand Clinical Trials Registry.
◦ ClinicalTrials.gov.
To be included, a trial must have a minimum follow-up of 12
◦ European Union (EU) Clinical Trials Register.
months from baseline. If multiple measures are available for a
◦ International Standard Randomised Controlled Trial
particular outcome, we will extract the measures closest to 12
Number (ISRCTN) Register.
months and 24 months for BMI or weight. For all other outcomes,
◦ Brazilian Clinical Trials Registry.
we will extract the measure closest to 24 months.
◦ Chinese Clinical Trials Registry.
• BMI: defined as weight (kg) divided by height (m) squared.
◦ Clinical Trials Registry - India.
• Weight: weight in kg.
◦ Clinical Research Information Service - Republic of
• Adverse event: any reported adverse event during
Korea.
intervention and follow-up.
◦ Cuban Public Registry of Clinical Trials.
• Indicator of body mass other than BMI or weight: defined
◦ German Clinical Trials Register.
as waist measurement, waist-to-hip ratio.
◦ Iranian Registry of Clinical Trials.
• Cardiometabolic disease: defined as development of type 2
◦ Japan Primary Registries Network.
diabetes, coronary heart disease or stroke.
◦ Pan African Clinical Trials Registry.
• All-cause mortality: defined as death from any cause.
◦ Sri Lanka Clinical Trials Registry.
• HrQoL: evaluated by a validated instrument. If multiple
◦ The Netherlands National Trial Register.
outcomes of HrQoL are reported, weight-specific HrQoL will be
◦ Thai Clinical Trials Register.
selected in preference to general HrQoL.
• Psychological factors: defined as depression, eating We will continuously apply a MEDLINE (via Ovid SP) email alert
disorders, anxiety, self-esteem. If multiple measures of service established by the Cochrane Metabolic and Endocrine Dis-
psychological distress are included in a publication we will select orders (CMED) Group to identify newly-published studies, using
the median of these measures for inclusion in the analyses. the same search strategy as described for MEDLINE (for details

Psychological interventions for adults who are overweight or obese (Protocol) 5

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
on search strategies, see Appendix 1). After supplying the final re-
view draft for editorial approval, the CMED Group will perform a
complete updated search on all databases available at the editorial
office and will send the results to the review authors. Should we
identify new studies for inclusion, we will evaluate these, incor-
porate the findings into our review, and resubmit another review
draft (Beller 2013).
If we detect additional relevant key words during any electronic
or other searches, we will modify the electronic search strategies
to incorporate these terms and will document the changes to the
search strategy.
Searching other resources
We will try to identify other potentially-eligible trials or ancillary
publications by searching the reference lists of retrieved included
trials, (systematic) reviews, meta-analyses and health technology
assessment reports. In addition we will contact authors of included
trials to identify any further studies we may have missed.
Data collection and analysis
Selection of studies
Two review authors (LB, ME) will independently scan the abstract
or title, or both, of every record retrieved, to determine which
studies should be assessed further. We will investigate all poten-
tially-relevant articles as full text. Full articles will be retrieved for
further assessment if the information given suggests that the study:
(1) includes participants who are overweight or obese; (2) com-
pares a psychological intervention to minimal or no intervention,
an active diet and/or exercise intervention or another psycholog-
ical intervention; and (3) uses random allocation to the compari-
son groups. If there is any doubt regarding these criteria from the
information given in the title and abstract, the full article will be
retrieved for clarification.
We will resolve any discrepancies through consensus or recourse
to a third review author (LB). If resolution of a disagreement is
not possible, we will add the article to those ’awaiting assessment’
and we will contact study authors for clarification. We will present
an adapted PRISMA (Preferred Reporting Items for Systematic
Reviews and Meta-Analyses) flow-chart showing the process of
study selection (Liberati 2009).
Data extraction and management
For studies that fulfil inclusion criteria, two review authors (ME,
KM) will independently abstract key participant and intervention
characteristics. We will report data on efficacy outcomes and ad-
verse events using standard data extraction templates supplied by
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
the CMED Group. We will resolve any disagreements by discus-
sion or, if required, by consultation with a third review author
(LB).
We will provide information (including trial identifier) about po-
tentially-relevant ongoing studies in the table ’Characteristics of
ongoing studies’ and in a joint appendix ’Matrix of study endpoint
(publications and trial documents)”. We will try to find the pro-
tocol for each included study and will report primary, secondary
and other outcomes in comparison with data in publications in a
joint appendix.
We will email all authors of included studies to enquire whether
they would be willing to answer questions regarding their trials. We
will present the survey results in an appendix. We will thereafter
seek relevant missing information on the trial from the primary
author(s) of the article, if required.
Dealing with duplicate and companion publications
In the event of duplicate publications, companion documents or
multiple reports of a primary trial, we will maximise the informa-
tion yield by collating all available data and will use the most com-
plete dataset aggregated across all known publications. We will list
duplicate publications, companion documents, multiple reports
of a primary trial and trial documents of included trials (such as
trial registry information) as secondary references under the study
identifier (ID) of the included trial. Furthermore, we will also list
duplicate publications, companion documents, multiple reports
of a trial and trial documents of excluded trials (such as trial reg-
istry information) as secondary references under the study ID of
the excluded trial.
Data from clinical trial registers
In case data of included trials are available as study results in clinical
trial registers such as ClinicalTrials.gov or similar sources, we will
make full use of this information and extract data. If there is also a
full publication of the trial, we will collate and critically appraise all
available data. If an included trial is marked as a completed study
in a clinical trial register but no additional information is available,
we will add this trial to the table ’Characteristics of studies awaiting
classification’.
Data extraction
We will extract the following data using a data extraction form:
1. General information: published/unpublished, title, authors,
source, contact address, country, language of publication, year of
publication, duplicate publications.
2. Trial characteristics: design, duration, randomisation (and
method), allocation concealment (and method), blinding
(participants, outcome assessors)
6
 3. Intervention: psychological intervention and comparison
interventions (intensity, duration, format, components),
measures of treatment fidelity and costs.
4. Participants: recruitment method, inclusion and exclusion
criteria, total number and number in comparison groups at
baseline and follow-up, number of therapists per arm (average
number of participants per therapist), diagnostic criteria of
overweight/obesity, socioeconomic status, ethnicity, gender, age,
comorbidities, baseline measures of all outcome variables,
assessment of compliance, withdrawals/losses to follow-up
(reasons/description).
5. Outcomes: outcomes specified above, what was the primary
outcome assessed in the study, and length of follow-up.
6. Results: for outcomes and times of assessment. Statistics
that can be algebraically manipulated to calculate an estimate of
intervention effect and its standard error (e.g. means, confidence
interval limits, exact P values).
Assessment of risk of bias in included studies
Two review authors (ME, KM) will independently assess the risk
of bias of each included trial. We will resolve any disagreements
by consensus, or by consultation with a third review author (JM).
In cases of disagreement, we will consult the rest of the review
authors and make a judgement based on consensus. If adequate
information is not available from trial authors, trial protocols or
both, we will contact trial authors for missing data on ’Risk of
bias’ items.
We will use the Cochrane ’Risk of bias’ assessment tool (Higgins
2011a; Higgins 2011b) and will judge ’Risk of bias’ criteria as
either ’low’, ’high’, or ’unclear’ risk and will evaluate individual
bias items as described in the Cochrane Handbook for Systematic
Reviews of Interventions (Higgins 2011a) where any of the specified
criteria for a judgement on ’low’, ’unclear’ or ’high’ risk of bias
justifies the associated categorisation.
Random sequence generation (selection bias due to
inadequate generation of a randomised sequence) -
assessment at trial level
We will describe for each included trial the method used to gen-
erate the allocation sequence in sufficient detail to allow an assess-
ment of whether it should produce comparable groups.
• Low risk of bias: sequence generation was achieved using
computer random number generation or a random number
table. Drawing of lots, tossing a coin, shuffling cards or
envelopes, and throwing dice are adequate if performed by an
independent person not otherwise involved in the trial. Use of
the minimisation technique will be considered as equivalent to
being random.
• Unclear risk of bias: insufficient information about the
sequence generation process.
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
• High risk of bias: the sequence generation method was non-
random (e.g. sequence generated by odd or even date of birth;
sequence generated by some rule based on date (or day) of
admission; sequence generated by some rule based on hospital or
clinic record number; allocation by judgement of the clinician;
allocation by preference of the participant; allocation based on
the results of a laboratory test or a series of tests; allocation by
availability of the intervention).
Allocation concealment (selection bias due to inadequate
concealment of allocations prior to assignment) - assessment
at trial level
We will describe for each included trial the method used to con-
ceal allocation to interventions prior to assignment and will assess
whether intervention allocation could have been foreseen in ad-
vance of, or during recruitment, or changed after assignment.
• Low risk of bias: central allocation (including telephone,
interactive voice-recorder, web-based and pharmacy-controlled
randomisation); sequentially numbered drug containers of
identical appearance; sequentially-numbered, opaque, sealed
envelopes.
• Unclear risk of bias: insufficient information about the
allocation concealment.
• High risk of bias: using an open random allocation schedule
(e.g. a list of random numbers); assignment envelopes were used
without appropriate safeguards; alternation or rotation; date of
birth; case record number; any other explicitly unconcealed
procedure.
We will also evaluate trial baseline data to incorporate assessment
of baseline imbalance into the ’Risk of bias’ judgement for selection
bias (Corbett 2014). Chance imbalances might also affect judge-
ments on the risk of attrition bias. In case of unadjusted analyses
we will distinguish between studies rated as at low risk of bias on
the basis of both randomisation methods and baseline similarity,
and studies rated as at low risk of bias on the basis of baseline
similarity alone (Corbett 2014). We will re-classify judgements of
unclear, low or high risk of selection bias as specified in Appendix
2.
Blinding of participants and study personnel (performance
bias due to knowledge of the allocated interventions by
participants and personnel during the trial) - assessment at
outcome level
We will evaluate the risk of detection bias separately for each out-
come (Hróbjartsson 2013). We will note whether endpoints were
self-reported, investigator-assessed or adjudicated outcome mea-
sures (see below).
• Low risk of bias: blinding of participants and key study
personnel ensured, and unlikely that the blinding could have
been broken; no blinding or incomplete blinding, but the review
7
authors judge that the outcome is not likely to be influenced by
lack of blinding.
• Unclear risk of bias: insufficient information about the
blinding of participants and study personnel; the trial did not
address this outcome.
• High risk of bias: no blinding or incomplete blinding, and
the outcome is likely to be influenced by lack of blinding;
blinding of trial participants and key personnel attempted, but
likely that the blinding could have been broken, and the
outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias due to
knowledge of the allocated interventions by outcome
assessment) - assessment at outcome level
We will evaluate the risk of detection bias separately for each out-
come (Hróbjartsson 2013). We will note whether endpoints were
self-reported, investigator-assessed or adjudicated outcome mea-
sures (see below).
• Low risk of bias: blinding of outcome assessment ensured,
and unlikely that the blinding could have been broken; no
blinding of outcome assessment, but the review authors judge
that the outcome measurement is not likely to be influenced by
lack of blinding.
• Unclear risk of bias: insufficient information about the
blinding of outcome assessors; the trial did not address this
outcome.
• High risk of bias: no blinding of outcome assessment, and
the outcome measurement is likely to be influenced by lack of
blinding; blinding of outcome assessment, but likely that the
blinding could have been broken, and the outcome measurement
is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias due to amount,
nature or handling of incomplete outcome data) - assessment
at outcome level
We will describe for each included trial, and for each outcome,
the completeness of data including attrition and exclusions from
the analysis. We will state whether attrition and exclusions were
reported and the number included in the analysis at each stage
(compared with the number of randomised participants per inter-
vention/comparator groups), if reasons for attrition or exclusion
where reported, and whether missing data were balanced across
groups or were related to outcomes. We will consider the implica-
tions of missing outcome data per outcome such as high drop-out
rates (e.g. above 15%) or disparate attrition rates (e.g. difference
of 10% or more between trial arms).
• Low risk of bias: no missing outcome data; reasons for
missing outcome data unlikely to be related to true outcome (for
survival data, censoring unlikely to be introducing bias); missing
outcome data balanced in numbers across intervention groups,
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
with similar reasons for missing data across groups; for
dichotomous outcome data, the proportion of missing outcomes
compared with observed event risk not enough to have a
clinically-relevant impact on the intervention effect estimate; for
continuous outcome data, plausible effect size (difference in
means or standardised difference in means) among missing
outcomes not enough to have a clinically-relevant impact on
observed effect size; appropriate methods, such as multiple
imputation, were used to handle missing data.
• Unclear risk of bias: insufficient information to assess
whether missing data in combination with the method used to
handle missing data were likely to induce bias; the trial did not
address this outcome.
• High risk of bias: reason for missing outcome data likely to
be related to true outcome, with either imbalance in numbers or
reasons for missing data across intervention groups; for
dichotomous outcome data, the proportion of missing outcomes
compared with observed event risk enough to induce clinically-
relevant bias in intervention effect estimate; for continuous
outcome data, plausible effect size (difference in means or
standardised difference in means) among missing outcomes
enough to induce clinically-relevant bias in observed effect size;
‘as-treated’ or similar analysis done with substantial departure of
the intervention received from that assigned at randomisation;
potentially inappropriate application of simple imputation.
Selective reporting (reporting bias due to selective outcome
reporting) - assessment at trial level
We will assess outcome reporting bias by integrating the results
of the appendix ’Matrix of trial endpoints (publications and trial
documents)’ (Boutron 2014; Mathieu 2009), with those of the
appendix ”High risk of outcome reporting bias according to OR-
BIT classification’ (Kirkham 2010). This analysis will form the
basis for the judgement of selective reporting.
• Low risk of bias: the trial protocol is available and all of the
trial’s pre-specified (primary and secondary) outcomes that are of
interest in the review have been reported in the pre-specified
way; the study protocol is not available but it is clear that the
published reports include all expected outcomes (ORBIT
classification).
• Unclear risk of bias: insufficient information about selective
reporting.
• High risk of bias: not all of the trial’s pre-specified primary
outcomes have been reported; one or more primary outcomes is
reported using measurements, analysis methods or subsets of the
data (e.g. subscales) that were not pre-specified; one or more
reported primary outcomes were not pre-specified (unless clear
justification for their reporting is provided, such as an
unexpected adverse effect); one or more outcomes of interest in
the review are reported incompletely so that they cannot be
entered in a meta-analysis; the trial report fails to include results
8
for a key outcome that would be expected to have been reported
for such a trial (ORBIT classification).
Other bias (bias due to problems not covered elsewhere) -
assessment at trial level
• Low risk of bias: the trial appeared to be free of other
sources of bias.
• Unclear risk of bias: insufficient information to assess
whether an important risk of bias existed; insufficient rationale
or evidence that an identified problem introduced bias.
• High risk of bias: had a potential source of bias related to
the specific trial design used; has been claimed to have been
fraudulent; had some other serious problem.
We will present a ’Risk of bias’ graph and a ’Risk of bias’ summary
figure.
We will distinguish between self-reported, investigator-assessed
and adjudicated outcome measures.
We define the following outcomes as self-reported.
• Health-related quality of life.
• Psychological factors.
• Adverse events, as measured by participants.
• BMI, as measured by participants.
• Weight, as measured by participants.
• Indicators of body mass other than BMI and weight loss, as
measured by participants.
We define the following outcomes as investigator-assessed.
• BMI, as measured by study personnel.
• Weight loss, as measured by study personnel.
• Indicators of body mass other than BMI and weight loss, as
measured by study personnel.
• Cardiometabolic disease.
• All-cause mortality.
• Cardiometabolic disease.
• Adverse events, as measured by study personnel.
Summary assessment of risk of bias
Risk of bias for a trial across outcomes: some risk of bias domains
like selection bias (sequence generation and allocation sequence
concealment) affect the risk of bias across all outcome measures in a
trial. In case of high risk of selection bias, all endpoints investigated
in the associated trial will be marked as ’high’ risk. Otherwise, we
will not perform a summary assessment of the risk of bias across
all outcomes for a trial.
Risk of bias for an outcome within a trial and across domains: we
will assess the risk of bias for an outcome measure including all
of the entries relevant to that outcome, i.e. both trial-level entries
and outcome-specific entries. ’Low’ risk of bias is defined as low
risk of bias for all key domains, ’unclear’ risk of bias as unclear risk
of bias for one or more key domains and ’high’ risk of bias as high
risk of bias for one or more key domains.
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Risk of bias for an outcome across trials and across domains: these
are our main summary assessments that will be incorporated in
our judgements about the quality of evidence in the ’Summary of
finding’ tables. ’Low’ risk of bias is defined as most information
coming from trials at low risk of bias, ’unclear’ risk of bias as most
information coming from trials at low or unclear risk of bias and
’high’ risk of bias as sufficient proportion of information coming
from trials at high risk of bias.
We will judge trials to be at a low risk of bias if the following
criteria are met: a low risk of bias for sequence generation, allo-
cation concealment, blinding of outcome assessment, incomplete
outcome data, and selective outcome reporting.
Measures of treatment effect
For continuous outcomes measured on the same scale (e.g. body
mass index (BMI)) we will estimate the intervention effect using
the mean difference (MD) with 95% confidence intervals (CI). For
continuous outcomes measuring the same underlying concept (e.g.
psychological distress) but using different measurement scales, we
will calculate the standardised mean difference (SMD). In trials
where the standard deviation (SD) of the outcome is not available
at follow-up, or cannot be recreated (e.g. only the SD of change
is reported), we will standardise by the pooled baseline SD. Risk
ratios (RR) with 99% CI will be used to estimate intervention
effects for dichotomous outcomes (cardiometabolic disease and
all-cause mortality). To aid interpretation, in our ’Summary of
findings’ table(s) we will also present risk differences for a range of
control group rates (lowest, highest, and median of the observed
control group rates).
Unit of analysis issues
In this review, unit of analysis issues are most likely to arise from
i) trials with more than two intervention groups, ii) cluster ran-
domised trials, and iii) trials with therapist clustering (arising
through the organisation of the intervention with therapists treat-
ing multiple patients). If more than one comparison from the same
trial is eligible for inclusion in the same meta-analysis, we will ap-
propriately reduce the sample size so that the same participants do
not contribute more than once. While this approach offers some
solution to adjusting the precision of the comparison, it does not
account for correlation arising from the same set of participants
being in multiple comparisons (Higgins 2011c).
We will attempt to re-analyse cluster randomised trials that have
not appropriately adjusted for potential clustering of participants
within clusters in their analysis.The variance of the intervention
effects will be inflated by a design effect (DEFF). Calculation of
a DEFF involves estimation of an intra-cluster correlation (ICC).
Estimates of ICCs will be obtained through contact with authors,
or imputed using estimates from other included studies that report
ICCs, or using external estimates from empirical research (e.g. Bell
2012).
9
In many psychological therapy trials, randomisation occurs at the
participant level, but clustering arises from therapists treating mul-
tiple patients; variation in outcomes for participants treated by the
same therapists may be smaller than for patients treated by dif-
ferent therapists (Walwyn 2010). The impact of not adjusting for
this clustering will be overly precise estimates of the intervention
effect, P values that are too small, and increased false positive con-
clusions that the intervention is effective.This form of clustering
is less well recognised, and consequently, it is likely that many tri-
als will not have adjusted for clustering. Further, few estimates of
ICCs will be available. We therefore plan to examine the impact
of clustering arising from nesting of participants within therapists
using sensitivity analyses and the approach described above.
Dealing with missing data
We will present attrition rates for the primary outcomes of the
review, BMI and weight loss, or an indicator of BMI or weight loss
when these outcome measures are not available. Reported results
may be based on observed case data, last observation carried for-
ward (LOCF), some other ad hoc imputation approach, or mul-
tiple imputation. Results based on multiple imputation will be
selected in preference to other imputation approaches, and if not
available, we will seek results based on observed case data.The sam-
ple of participants on which the results are based will be reported
in the review (e.g. observed case, LOCF, multiple imputation).
We will also extract information on the trial analytical approach,
since different analytical approaches are valid under different as-
sumptions about the missing data (Bell 2013). For the primary
outcomes, we will undertake sensitivity analyses to examine the
robustness of the pooled intervention effect to missing data. In
trials with missing summary statistics (e.g. SDs) we will impute
these statistics using methods outlined in Hozo (Hozo 2005) and
report the assumptions we have made in the results tables.
Assessment of heterogeneity
We will assess heterogeneity visually by inspecting the overlap of
CIs on the forest plots. We will formally test for heterogeneity
using the Chi² test (using a significance level of α = 0.1), and
quantify heterogeneity using the I² statistic (Higgins 2002). CIs
for estimated values of I² will be calculated using the non central
Chi² approximation implemented in the module heterogi (Orsini
2006) in the statistical package Stata (StataCorp: Stata Statisti-
cal Software: Release 12. In. College Station, TX: StataCorp LP.;
2011).
Assessment of reporting biases
Funnel plots and contour-enhanced funnel plots will be used to
investigate if there is evidence of small study effects for the out-
come BMI (Peters 2008; Sterne 2011). The Egger test for funnel
plot asymmetry will be applied if there are sufficient trials (at least
Psychological interventions for adults who are overweight or obese (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
10 for a particular outcome) (Egger 1997). The test will be imple-
mented using the module metabias (Harbord 2009) in the statis-
tical package Stata (StataCorp: Stata Statistical Software: Release
12. In. College Station, TX: StataCorp LP.; 2011).
Data synthesis
Estimates of intervention effect will be pooled using a random-
effects model, since we expect there will be diversity in the clinical
populations and interventions. DerSimonian and Laird’s method
of moments estimator will be used to estimate between-trial vari-
ance (DerSimonian 1986). We plan to also examine the robust-
ness of the results to the meta-analysis method by using the
restricted maximum likelihood between-trial variance estimator
(Raudenbush 2009) and the Knapp and Hartung method to cal-
culate the CI (Knapp 2003). We plan to fit prediction intervals in
the presence of unexplained heterogeneity, providing a predicted
range for the true intervention effect in a new trial (Riley 2011).
Quality of evidence
We will present the overall quality of the evidence for each out-
come according to the Grading of Recommendations Assessment,
Development and Evaluation (GRADE) approach, which takes
into account issues related not only to internal validity (risk of
bias, inconsistency, imprecision, publication bias) but also to ex-
ternal validity, such as directness of results. Two review authors
(ME, KM) will independently rate the quality of evidence for each
outcome. We will present a summary of the evidence in a ’Sum-
mary of findings’ table. This will provide key information about
the best estimate of the magnitude of the effect, if possible in rel-
ative terms and as absolute differences, for each relevant compari-
son of alternative management strategies, numbers of participants
and trials addressing each important outcome and rating of overall
confidence in effect estimates for each outcome. We will create
the ’Summary of findings’ table on the basis of methods described
in the Cochrane Handbook for Systematic Reviews of Interventions
(Higgins 2011a). We will present results for the outcomes as de-
scribed in the Types of outcome measures section. If meta-analysis
is not possible, we will present the results in a narrative ’Summary
of findings’ table.
In addition, we will establish an appendix ’Checklist to aid consis-
tency and reproducibility of GRADE assessments’ (Meader 2014)
to help with standardisation of the ’Summary of findings’ tables.
Should we use the GRADEpro software (www.gradepro.org) we
will attach evidence profile tables as an appendix.
Subgroup analysis and investigation of heterogeneity
We plan to undertake subgroup analyses or random-effects meta-
regression to investigate if the magnitude of intervention effect for
the primary outcomes of BMI and weight loss is modified by the
following intervention and participant factors.
10
 • Long-term weight loss is the goal of obesity interventions,
however the majority of participants regain lost weight over time.
• Behavioural therapies can be further divided into first wave
(behavioural), second wave (cognitive behavioural) and third
wave (mindfulness, acceptance, metacognition) therapies. Each is
based on a different conceptualisation of behavioural and
cognitive factors and uses different behavioural and cognitive
intervention strategies which may have different impacts on
outcomes.
• Intervention effects are likely to be modified by the degree
of participant excess weight (overweight versus obese) at baseline.
Individuals who are obese have more weight to lose, and are
likely to have more extreme comorbidities, so greater
improvements may be expected in this group.
Therefore the following will be considered in analyses.
• Length of follow-up (12 versus 24 months).
• Type of behavioural intervention (first wave, second wave,
third wave).
• Participant degree of excess weight (overweight versus
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∗
Indicates the major publication for the study

APPENDICES

Appendix 1. Search strategies

Cochrane Library

1. [mh Ôbesity]
2. [mh ˆ“Obesity, Abdominal“]
3. [mh ˆ“Obesity, Morbid“]
4. [mh ˆ“Weight Loss“]
5. [mh Ôverweight]
6. (obes* or overweight):ti,ab,kw
7. (weight next (reduction or loss or control or management)):ti,ab,kw
8. {or #1-#7}
9. [mh Psychotherapy]
10. [mh Counseling]
11. ((psycho* or behav*) near/3 (therap* or treatment* or intervention* or counsel* or support*)):ti,ab,kw
12. ((behavior* or behaviour* or motivation*) near/3 (activation or therap* or treatment* or intervention* or modification* or
13. contract* or program* or counsel*)):ti,ab,kw
14. (cognitiv* near/3 (therap* or treatment* or intervention* or control* or program*)):ti,ab,kw
15. (train* near/3 (autogenic or assertive* or mind or sensitivity or relax*)):ti,ab,kw
16. ((art or aversion or color or colour or conversion or group or insight or supportiv* or exposure or play) next (therap* or
psychotherap*)):ti,ab,kw
17. ((acceptance* or “activity scheduling” or adlerian or brief or “client cent*” or commitment* or compassion* or conjoint or
conversational or couples or dance or dialectic* or eclectic or (emotion* near/2 focus*) or existential or experiential or expressive
or family or (focus* near/2 oriented) or gestalt or humanistic or imagery or implosive or integrative or interpersonal or marital or

Psychological interventions for adults who are overweight or obese (Protocol) 15

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

metacognitive or milieu or morita or “multi modal” or multimodal or music or narrative or “non directive” or nondirective or “non
specific” or nonspecific or “object relations” or “personal construct” or “person cent*” or persuasion or “pleasant event*” or primal
or “problem focused” or “problem solving” or “process experiential” or psychodynamic or “rational emotive” or reality or “reciprocal
inhibition” or relationship* or relax* or reminiscence or restructuring or schema* or “self control*” or selfcontrol* or “short term”
or sex or “social effectiveness” or “social skill*” or “socio environmental” or socioenvironmental or “solution focused” or “stress
management” or tapping or “time limited” or transference or transtheoretical or validation) near/3 (therap* or psychotherap*)):ti,ab,
kw
18. (abreaction or “acting out” or “age regression” or autosuggestion or “balint group*” or biofeedback or catharsis or “contingency
management” or countertransference or “covert sensitization” or “eye movement desensiti*” or “crisis intervention” or distraction or
“dream analysis” or “emotional freedom” or “emotional healing tech*” or “free association” or freudian or “functional analysis” or
griefwork or “guided imagery” or hypnos* or hypnotherap* or jungian or kleinian or logotherap* or meditation* or “mental healing”
or mindfulness or (paradoxic* next technique*) or psychoanaly* or psychodram* or “psycho educat*” or psychoeducat* or “psycho
ped*” or psychoped* or “relaxation techni*” or rogerian or “role play*” or “self analysis” or “self esteem” or sociotherap* or (support*
near/2 group*) or therapist or (therapeutic* next technique*) or “third wave” or “transactional analysis”):ti,ab,kw
19. {or #9-#17}
20. #8 and #18

MEDLINE (Ovid SP)

1. Obesity/
2. Obesity, Abdominal/
3. Obesity, Morbid/
4. Weight Loss/
5. Overweight/
6. (obes* or overweight).tw.
7. (weight adj (reduction or loss or control or management)).tw
8. or/1-7
9. exp Psychotherapy/
10. exp Counseling/
11. ((psycho* or behav*) adj3 (therap* or treatment* or intervention* or counsel* or support*)).tw
12. ((behavio?r* or motivation*) adj3 (activation or therap* or treatment* or intervention* or modification* or contract* or program*
or counsel*)).tw
13. (cognitiv* adj3 (therap* or treatment* or intervention* or control* or program*)).tw
14. (train* adj3 (autogenic or assertive* or mind or sensitivity or relax*)).tw
15. ((art or aversion or colo?r or conversion or group or insight or supportiv* or exposure or play) adj (therap* or psychotherap*)).tw
16. ((acceptance* or activity scheduling or adlerian or brief or client cent* or commitment* or compassion* or conjoint or conversational
or couples or dance or dialectic* or eclectic or emotion* focus* or existential or experiential or expressive or family or focus* oriented
or gestalt or humanistic or imagery or implosive or integrative or interpersonal or marital or metacognitive or milieu or morita or
multimodal or multi modal or music or narrative or nondirective or non directive or nonspecific or non specific or object relations
or personal construct or person cent* or persuasion or pleasant event* or primal or problem focused or problem solving or process
experiential or psychodynamic or rational emotive or reality or reciprocal inhibition or relationship* or relax* or reminiscence or
restructuring or schema* or self control* or selfcontrol* or short term or sex or social effectiveness or social skill* or socio environmental
or socioenvironmental or solution focused or stress management or tapping or time limited or transference or transtheoretical or
validation) adj3 (therap* or psychotherap*)).tw
17. (abreaction or acting out or age regression or autosuggestion or balint group* or biofeedback or catharsis or contingency manage-
ment or countertransference or covert sensitization or eye movement desensiti* or crisis intervention or distraction or dream analysis
or emotional freedom or emotional healing tech* or free association or freudian or functional analysis or griefwork or guided imagery
or hypnos* or hypnotherap* or jungian or kleinian or logotherap* or meditation* or mental healing or mindfulness or paradoxic*
technique* or psychoanaly* or psycho analy* or psychodram* or psychoeducat* psycho educat* or psychoped* or psycho ped* or

Psychological interventions for adults who are overweight or obese (Protocol) 16

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

relaxation techni* or rogerian or role play* or self analysis or self esteem or sociotherap* or support* group* or therapist or therapeutic*
technique* or third wave or transactional analysis).tw
18. or/9-17
19. 8 and 18
[20-29: Cochrane Handbook 2008 RCT filter - sensitivity maximizing version - without “drug therapy.fs.”]
20. randomized controlled trial.pt.
21. controlled clinical trial.pt.
22. randomi?ed.ab.
23. placebo.ab.
24. randomly.ab.
25. trial.ab.
26. groups.ab.
27. or/20-26
28. exp animals/ not humans/
29. 28 not 27
30. 19 and 29
31. remove duplicates from 30

PsycINFO (Ovid SP)

1. Obesity/
2. Overweight/
3. Weight Loss/
4. Weight Control/
5. Obesity (Attitudes Toward)/
6. (overweight or obes*).tw.
7. (weight adj (reduction or loss or control or management)).tw
8. or/1-7
9. exp Behavior Modification/
10. exp Cognitive Techniques/
11. exp Creative Arts Therapy/
12. exp Milieu Therapy/
13. exp Psychotherapy/
14. exp Psychotherapeutic Techniques/
15. exp Relaxation Therapy/
16. exp Sociotherapy/
17. exp Behavior Contracting/
18. exp Mindfulness/
19. exp Mind Body Therapy
20. exp Support Groups/
21. ((psychol* or psychodynam* or psychosoci* or psycho-soci* or psycho-physi* or psychotherap*) adj3 (therap* or treatment* or
intervention* or counsel* or support*)).tw
22. ((behavio?r* or motivation*) adj3 (activation or therap* or treatment* or intervention* or modification* or contract* or program*
or counsel*)).tw
23. (cognitiv* adj3 (therap* or treatment* or intervention* or control* or program*)).tw
24. (train* adj3 (autogenic or assertive* or mind or sensitivity or relax*)).tw
25. ((art or aversion or colo?r or conversion or group or insight or supportiv* or exposure or play) adj (therap* or psychotherap*)).tw
26. ((acceptance* or activity scheduling or adlerian or brief or client cent* or commitment* or compassion* or conjoint or conversational
or couples or dance or dialectic* or eclectic or emotion* focus* or existential or experiential or expressive or family or focus* oriented

Psychological interventions for adults who are overweight or obese (Protocol) 17

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

or gestalt or humanistic or imagery or implosive or integrative or interpersonal or marital or metacognitive or milieu or morita or
multimodal or multi modal or music or narrative or nondirective or non directive or nonspecific or non specific or object relations
or personal construct or person cent* or persuasion or pleasant event* or primal or problem focused or problem solving or process
experiential or psychodynamic or rational emotive or reality or reciprocal inhibition or relationship* or relax* or reminiscence or
restructuring or schema* or self control* or selfcontrol* or short term or sex or social effectiveness or social skill* or socio environmental
or socioenvironmental or solution focused or stress management or tapping or time limited or transference or transtheoretical or
validation) adj3 (therap* or psychotherap*)).tw
27. (abreaction or acting out or age regression or autosuggestion or balint group* or biofeedback or catharsis or contingency manage-
ment or countertransference or covert sensitization or eye movement desensiti* or crisis intervention or distraction or dream analysis
or emotional freedom or emotional healing tech* or free association or freudian or functional analysis or griefwork or guided imagery
or hypnos* or hypnotherap* or jungian or kleinian or logotherap* or meditation* or mental healing or mindfulness or paradoxic*
technique* or psychoanaly* or psychodram* or psychoeducat* or psychoped* or relaxation techni* or rogerian or role play* or self
analysis or self esteem or sociotherap* or therapist or therapeutic* technique* or third wave or transactional analysis).tw
28. or/9-27
29. 8 and 28
[30: Eady 2008- PsycINFO search strategies filter - BS version]
30. (control* or random*).tw. or exp Treatment/
31. 29 and 30
32. limit 31 to (“0100 journal” or “0110 peer-reviewed journal” or “0120 non-peer-reviewed journal” or “0130 peer-reviewed status
unknown” or “0400 dissertation abstract”)

ICTRP Search Portal (Standard search)

obes* AND psycho* OR

obes* AND behavio* OR
obes* AND cognitiv* OR
obes* AND counsel* OR
obes* AND emotion* OR
obes* AND hypno* OR
obes* AND meditation* OR
obes* AND mindfulness* OR
overweight* AND psycho* OR
overweight* AND behavio* OR
overweight* AND cognitiv* OR
overweight* AND counsel* OR
overweight* AND emotion* OR
overweight* AND hypno* OR
overweight* AND meditation* OR
overweight* AND mindfulness*

ClinicalTrials.gov (Expert search)

INFLECT EXACT “Interventional” [STUDY-TYPES] AND INFLECT EXACT “Adult” [AGE-GROUP] | obese OR obesity
OR overweight OR “weight loss” OR “weight reduction” OR “weight control” OR “weight management” | psychotherapy OR
psychotherapeutic OR psychotherapeutical OR psychological OR “acting out” OR “age regression” OR autogenic OR autosuggestion
OR assertive OR art OR aversion OR abreaction OR acceptance OR “activity scheduling” OR adlerian OR balint OR behavioural
OR behavioral OR behaviour OR behavior OR biofeedback OR dance OR dialectic OR distraction OR “dream analysis” OR catharsis
OR color OR colour OR “contingency management” OR cognitive OR conversion OR countertransference OR “covert sensitization”
OR “client centered” OR commitment OR compassion OR conjoint OR conversational OR counseling OR couples OR “crisis

Psychological interventions for adults who are overweight or obese (Protocol) 18

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

intervention” OR “eye movement” OR eclectic OR emotion OR emotional OR existential OR experiential OR expressive OR family
OR “focus oriented” OR “free association” OR freudian OR “functional analysis” OR “group therapy” OR gestalt OR griefwork OR
“guided imagery” OR humanistic OR hypnosis OR hypnotherapy OR insight OR implosive OR integrative OR interpersonal OR
jungian kleinian OR logotherapy OR marital OR metacognitive OR milieu OR mind OR morita OR motivation OR motivational
OR modification OR “multi modal” OR multimodal OR music OR meditation OR “mental healing” OR mindfulness OR narrative
OR “non directive” OR nondirective OR “non specific” OR nonspecific OR “object relations” OR “personal construct” OR “person
centered” OR persuasion OR play OR “pleasant event” OR primal OR “problem focused” OR “problem solving” OR psychodynamic
OR “psycho dynamic” OR paradoxic OR paradoxical OR “psycho analysis” OR psychoanalysis OR psychodrama OR “psycho
education” OR psychoeducation OR “psycho pedagogical” OR psychopedagogical OR “rational emotive” OR reality OR “reciprocal
inhibition” OR relationship OR relaxation OR reminiscence OR restructuring OR rogerian OR “role play” OR “schema therapy” OR
“self control” OR selfcontrol OR “sensitivity training” OR sex OR “social effectiveness” OR “social skills” OR “socio environmental”
OR socioenvironmental OR “solution focused” OR “stress management” OR support OR supportive OR “self analysis” AND or
AND “self esteem” AND or sociotherapy OR tapping OR “time limited” OR transference OR transtheoretical OR therapist OR
“third wave” OR “transactional analysis” OR “validation therapy”

Appendix 2. Selection bias decisions

Selection bias decisions for trials reporting unadjusted analyses: comparison of results obtained using method details alone
with results using method details and trial baseline informationa

Reported randomisation and Risk of bias judgement using Information gained from Ris of bias using baseline in-
allocation concealment meth- methods reporting study characteristics data formation and methods re-
ods porting

Unclear methods Unclear risk Baseline imbalances present for High risk
important prognostic variable
(s)

Groups appear similar at base- Low risk

line for all important prognos-
tic variables

Limited or no baseline details Unclear risk

Would generate a truly random Low risk Baseline imbalances present for Unclear riskc
sample, with robust allocation important prognostic variable
concealment (s)

Groups appear similar at base- Low risk

line for all important prognos-
tic variables

Limited baseline details, show- Low risk

ing balance in some important
prognostic variablesb

Psychological interventions for adults who are overweight or obese (Protocol) 19

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

No baseline details Unclear risk

Sequence is not truly ran- High risk Baseline imbalances present for High risk
domised, or allocation conceal- important prognostic variable
ment is inadequate (s)

Groups appear similar at base- Low risk

line for all important prognos-
tic variables

Limited baseline details, show- Unclear risk

ing balance in some important
prognostic variablesb

No baseline details High risk

a Taken from Corbett 2014; judgements highlighted in grey indicate situations in which the addition of baseline assessments would

change the judgement about risk of selection bias, compared with using methods reporting alone.
b Details for the remaining important prognostic variables are not reported.
c There is an imbalance which is likely due to chance.

CONTRIBUTIONS OF AUTHORS
LB led the development of the protocol. JM led the protocol design. MIM designed the search strategies. All protocol authors read and
approved the final protocol draft.

DECLARATIONS OF INTEREST
LB: none known.
ME: none known.
KM: none known.
XPG: none known.
MIM: none known.
JM: none known.

Psychological interventions for adults who are overweight or obese (Protocol) 20

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
NOTES
We have based parts of the Methods and Appendix 1 sections of this Cochrane Protocol on a standard template established by the
CMED Group.

Psychological interventions for adults who are overweight or obese (Protocol) 21

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.