Abstract | BACKGROUND: METHOD/DESIGN: A 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: TRIAL REGISTRATION: US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.
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Authors | Marly Amorim Palavras, Phillipa Hay, Stephen Touyz, Amanda Sainsbury, Felipe da Luz, Jessica Swinbourne, Nara Mendes Estella, Angélica Claudino |
Journal | Trials
(Trials)
Vol. 16
Pg. 578
(Dec 18 2015)
ISSN: 1745-6215 [Electronic] England |
PMID | 26683478
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Behavior Therapy
(methods)
- Binge-Eating Disorder
(diagnosis, physiopathology, psychology, therapy)
- Body Mass Index
- Brazil
- Bulimia Nervosa
(diagnosis, physiopathology, psychology, therapy)
- Clinical Protocols
- Cognitive Behavioral Therapy
- Combined Modality Therapy
- Comorbidity
- Eating
- Feeding Behavior
- Female
- Humans
- Male
- Obesity
(diagnosis, physiopathology, psychology, therapy)
- Overweight
(diagnosis, physiopathology, psychology, therapy)
- Psychiatric Status Rating Scales
- Quality of Life
- Research Design
- Single-Blind Method
- Surveys and Questionnaires
- Time Factors
- Treatment Outcome
- Weight Loss
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