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/m2, 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.DiscussionThis 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1079-1) contains supplementary material, which is available to authorized users.
Highlights
Around 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese
The inclusion criteria are: age ≥ 18 years; either sex; a primary eating disorder diagnosis of bulimia nervosa (BN) or binge eating disorder (BED) type according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and/or the proposed International Classification of Diseases, eleventh version (ICD-11) criteria [2, 3]; and a body mass index (BMI) ≥ 27 and < 40 kg/m2
The information at recruitment that will be provided to participants regarding the therapy is as follows: ‘We have developed an approach that integrates techniques from cognitive behavioural therapy for eating disorders with behavioural strategies for weight loss
Summary
Around 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese. The combined general population lifetime prevalence of bulimia nervosa (BN) and binge eating disorder (BED) is around 5 % in women and 3 % in men [1] Both disorders are characterised by recurrent binge eating or uncontrolled overeating episodes which, in the case of BN are associated with regular compensatory weight control behaviours (e.g., self-induced vomiting) [2, 3]. In a paper to highlight the issues of managing weight and eating disorders, that ‘BN in the overweight and obese patients may represent the natural evolution of the eating disorder on the backdrop of the obesity epidemic’ (Bulik et al, p.6) [8] They wrote about the increase in clinical presentations of overweight and obese patients with BN and their requests for help with weight management. They argued that due to the rise in combined prevalence of co-morbid obesity and BN and BED, and their shared risk and maintaining features, an urgent need for new approaches to management is needed [8]
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