Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED)
- Conditions
- Eating DisorderBinge Eating DisorderBulimia Nervosa
- Interventions
- Behavioral: CBT-EBehavioral: HAPIFED
- Registration Number
- NCT02464345
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
The investigators have developed a new integrated therapy, namely a Healthy Approach to weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. The investigators propose a randomized controlled trial (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be conducted in Sydney and in São Paulo with a one year follow-up.
- Detailed Description
In sum, a new approach in management of the increasing numbers of obese people with BN and BED is needed. The investigators propose a RCT that will compare a novel therapy HAPIFED with the current 'gold-standard' trans diagnostic treatment, CBT-E. HAPIFED has been developed by the CIs and is based on recent developments in psychological approaches to obesity in general (as highlighted in Casazza et al.'s (2013) paper on "Myths, presumptions and facts about obesity") and in people with co-morbid obesity and BN or BED. Unlike CBT-E, it allows reduced energy intake and education around specific food choices - a necessary element in weight loss.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)
- BMI between ≥ 27 and < 40
- Diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk.
- Use of weight loss medication or medications that interfere with appetite.
- Cushing or Prader-Willi syndromes
- History of bariatric surgery
- Patients who are already in treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT-E CBT-E CBT-E therapy HAPIFED HAPIFED HAPIFED therapy
- Primary Outcome Measures
Name Time Method Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes. Baseline, 25-weeks (end) treatment, 6 and12 months follow-up. Change of 5% of body weight.
- Secondary Outcome Measures
Name Time Method Change in binge eating frequency Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire
Severity of loss of control over eating Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score
Improved metabolic indicators of weight management Baseline, 25 weeks (end) treatment Waist and Hip circumference and blood markers (Blood fasting lipid profile, fasting glucose matched with insulin, liver function tests, electrolytes, urea, uric acid and creatinine.
Change in severity of binge eating Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire
Change in the levels of depression, anxiety and stress. Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. Changed level of depression, anxiety and stress as measured on the Depression, Anxiety and Stress Scale 21 item questionnaire - subscale scores of depression, anxiety and stress
Health related quality of life Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. Improved physical and mental health related quality of life as measured by increased scores on the Short Form 12-item survey (SF-12) Physical and Mental Health Component scores
Trial Locations
- Locations (1)
Universidade Federal de Sao Paulo (UNIFESP)
🇧🇷Sao Paulo, SP, Brazil