Integrated weight loss and cognitive behavioural therapy (CBT) for the treatment of recurrent binge eating and high body mass index: a randomized controlled trial



The association between binge eating and obesity is increasing. Treatments for disorders of recurrent binge eating comorbid with obesity reduce eating disorder (ED) symptoms, but not weight. This study investigated the efficacy and safety of introducing a weight loss intervention to the treatment of people with disorders of recurrent binge eating and a high body mass index (BMI).


A single-blind randomized controlled trial selected adults with binge eating disorder or bulimia nervosa and BMI ≥ 27 to < 40 kg/m2. The primary outcome was sustained weight loss at 12-month follow-up. Secondary outcomes included ED symptoms. Mixed effects models analyses were conducted using multiple imputed datasets in the presence of missing data.


Ninety-eight participants were randomized to the Health Approach to Weight Management and Food in Eating Disorders (HAPIFED) or to the Cognitive Behavioural Therapy-Enhanced (CBT-E). No between-group differences were found for percentage of participants achieving weight loss or secondary outcomes, except for reduction of purging behaviour, which was greater with HAPIFED (p = 0.016). Binge remission rates specifically at 12-month follow-up favoured HAPIFED (34.0% vs 16.7%; p = 0.049). Overall, significant improvements in the reduction of ED symptoms were seen in both groups and these were sustained at the 12-month follow-up.


HAPIFED was not superior to CBT-E in promoting clinically significant weight loss and was not significantly different in reducing most ED symptoms. No harm was observed with HAPIFED, in that no worsening of ED symptoms was observed. Further studies should test approaches that target both the management of ED symptoms and the high BMI.

Level of evidence

Level I, randomized controlled trial

Trial registration

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

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Fig. 1

Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.


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The authors acknowledge Jessica Swinbourne who contributed to the HAPIFED manual development, Nara Mendes who contributed to the translation of LOCES and protocol development, Mireille Coelho and Mitti Koyama for the support with different aspects of the trial and the entire team of professionals from PROATA who collaborated with the study execution.


This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior–Brasil (CAPES)–Finance Code 001. PH was part supported by the School of Medicine WSU for travel to Sao Paulo including sabbatical leave in 2012. AS was supported by the National Health and Medical Research Council (NHMRC) of Australia via Senior Research Fellowships (1042555 and 1135897) and via a Sydney Outstanding Academic Researcher (SOAR) Fellowship–the University of Sydney. FQdL was supported by The São Paulo Research Foundation (FAPESP) via a Young Investigator Fellowship.

Author information




All authors contributed to the study conception and design. Material preparation and data collection were performed by Marly A. Palavras, and analysis was performed by Marly A. Palavras, Haider Mannan, Phillipa Hay and Angélica M. Claudino. The first draft of the manuscript was written by Marly A. Palavras, Phillipa Hay and Angélica M. Claudino. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Marly Amorim Palavras.

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Conflicts of interest

Marly A. Palavras participated in a 2016 meeting of an advisory board for the treatment of binge eating disorder at Shire Pharmaceuticals, Brazil. Phillipa Hay receives/has received sessional fees and lecture fees from the Australian Medical Council, Therapeutic Guidelines publication and New South Wales Institute of Psychiatry; royalties/honoraria from Hogrefe and Huber, McGraw Hill Education, Blackwell Scientific Publications, Biomed Central and PlosMedicine; and has received research grants from the NHMRC and ARC. She is Chair of the National Eating Disorders Collaboration Steering Committee in Australia (2019–) and a Member of the ICD-11 Working Group for Eating Disorders (2012–2018) and was Chair of the Clinical Practice Guidelines Project Working Group (Eating Disorders) of RANZCP (2012–2015). She has received honoraria from Shire Pharmaceuticals for educational seminars for psychiatrists and prepared a commissioned report. Angélica M. Claudino is a member of the World Health Organization Working Group on Feeding and Eating Disorders for the Revision of ICD-10 Mental and Behavioral Disorders. Amanda Sainsbury is the author of The Don’t Go Hungry Diet (Bantam, Australia and New Zealand, 2007) and Don’t Go Hungry for Life (Bantam, Australia and New Zealand, 2011). She has also received payment from Eli Lilly, the Pharmacy Guild of Australia, Novo Nordisk, the Dietitians Association of Australia, Shoalhaven Family Medical Centres, the Pharmaceutical Society of Australia, and Metagenics for presentation at conferences, and served on the Nestlé Health Science Optifast® VLCDTM Advisory Board from 2016 to 2018. Stephen Touyz receives royalties from Hogrefe and Huber, Routledge and McGraw-Hill Publishers. He has also been the recipient of honoraria and travel and research grants from Shire Pharmaceuticals. He has chaired their Australian Binge-Eating Disorder Advisory Board and has been the author of commissioned reports. All views expressed in these reports have been his own. He is a mental health advisor to the Australian Commonwealth Department of Veterans Affairs and a consultant to Weight Watchers (WW). Haider Mannan and Felipe Quinto da Luz have no conflicts of interest to report.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Human Research Ethics Committee of UNIFESP (CAAE 43874315.4.0000.5505).

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Informed consent was obtained from all participants included in the study.

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Palavras, M.A., Hay, P., Mannan, H. et al. Integrated weight loss and cognitive behavioural therapy (CBT) for the treatment of recurrent binge eating and high body mass index: a randomized controlled trial. Eat Weight Disord 26, 249–262 (2021).

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  • Binge-eating disorder
  • Bulimia nervosa
  • Therapy
  • Weight loss