Evidence map›Paper›PMID 26683478›Full record

Trial reportTrials2015

Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial.

Marly Amorim Palavras, Phillipa Hay, Stephen Touyz, Amanda Sainsbury, Felipe da Luz, Jessica Swinbourne, Nara Mendes Estella, Angélica Claudino

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02464345 (A Randomised Controlled Trial of a New Integrated Approach to Management of Eating and Weight Disorders, Namely a Healthy APproach to weIght Management and Food in Eating Disorders Compared to Cognitive Behaviour Therapy Enhanced.), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02464345 nacompletednot on this map

A Randomised Controlled Trial of a New Integrated Approach to Management of Eating and Weight Disorders, Namely a Healthy APproach to weIght Management and Food in Eating Disorders Compared to Cognitive Behaviour Therapy Enhanced.

TypeinterventionalSponsorFederal University of São PauloRan2015 to 2019Enrolled98ConditionsBinge Eating Disorder, Bulimia Nervosa, Eating DisorderArmsHAPIFED, CBT-E
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
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  9. Binge Eating Disorder in Patients with Type 2 Diabetes: Diagnostic and Management Challenges.Diabetes, metabolic syndrome and obesity : targets and therapy · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Marly Amorim PalavrasEating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. marlypalavras@gmail.com.
Phillipa HayCAPES Foundation, Ministry of Education, São Paulo, Brazil. P.Hay@westernsydney.edu.au.
Stephen TouyzSchool of Psychology, Faculty of Science, The University of Sydney, Camperdown, NSW, Australia. stephen.touyz@sydney.edu.au.
Amanda SainsburyThe Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, Sydney, NSW, Australia. amanda.salis@sydney.edu.au.
Felipe da LuzCAPES Foundation, Ministry of Education, São Paulo, Brazil. felipe.quintodaluz@sydney.edu.au.
Jessica SwinbourneThe Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, Sydney, NSW, Australia. jessica.swinbourne@sydney.edu.au.
Nara Mendes EstellaEating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. naramendes@post.harvard.edu.
Angélica ClaudinoEating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. angelica.claudino@uol.com.br.
University of Sydney · AUCoordenação de Aperfeicoamento de Pessoal de Nível Superior · BRMinistry of Education · BRUniversidade Federal de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAround 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese. In contrast to binge eating disorder, currently there is no evidence base for weight management or weight loss psychological therapies in the treatment of bulimia nervosa despite their efficacy in binge eating disorder. Thus, a manualised therapy called HAPIFED (Healthy APproach to weIght management and Food in Eating Disorders) has been developed. HAPIFED integrates the leading evidence-based psychological therapies, cognitive behavioural therapy-enhanced (CBT-E) and behavioural weight loss treatment (BWLT) for binge eating disorder and obesity respectively. The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of HAPIFED versus CBT-E for people with bulimia nervosa and binge eating disorder who are overweight/obese. METHOD/

designA single-blind superiority RCT is proposed. One hundred Brazilian participants aged ≥ 18 years, with a diagnosis of bulimia nervosa or binge eating disorder, BMI > 27 to < 40 kg/m(2), will be recruited from both community and clinics and individually randomised to a therapy arm. Five groups of ten participants will receive the experimental intervention (HAPIFED) and the other five groups of ten the control intervention (CBT-E). Both therapies are manualised, and in this RCT will comprise 1 individual session and 29 office-based group sessions over 6 months. Assessment points will be at baseline, end of therapy, and 6 and 12 months after end of therapy. The primary outcome of this intervention will be reduced weight. Secondary outcomes will be improved metabolic indicators of weight management, reduction in eating disorder symptoms including improved control over eating, improved adaptive function, physical and mental health-related quality of life, and reduced levels of depression and anxiety. DISCUSSION: This study will be the first to investigate a psychological therapy that aims to assist weight management in people with co-morbid overweight or obesity bulimia nervosa as well as with binge eating disorder. It will have the potential to improve health outcomes for the rapidly increasing number of adults with co-morbid obesity and binge eating disorder or bulimia nervosa.

trial registrationUS National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.

Indexed as

Cognitive Behavioral TherapyFeeding BehaviorWeight LossBehavior TherapyBinge-Eating DisorderBody Mass IndexBrazilBulimia NervosaClinical ProtocolsCombined Modality TherapyComorbidityEatingFemaleHumansMaleObesity

Identifiers

PMID26683478
PMCPMC4683762
OpenAlexW2212734000

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.