An interventional study of HAPIFED and CBT-E in Binge Eating Disorder, Bulimia Nervosa and Eating Disorder, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
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.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's enrollment of 98 is above the median of 61 across 249 interventional studies indexed under Bulimia.
Browse Bulimia studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
HAPIFED therapy
Behavioral: HAPIFED
CBT-E therapy
Behavioral: CBT-E
HAPIFED is adapted from CBT to promote a positive relationship with food, eating and activity, appetite awareness, and weight loss to be achieved over a longer and more intensive period of therapy, thus recognizing the importance of longer-term therapy in weight loss (Casazza et al., 2013). Notably, HAPIFED is also multidisciplinary. Clinical practice and consensus views are to utilize the special expertise of dietitians and other allied health professionals (Robinson, 2009).
CBT-E therapy
Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes.
Change of 5% of body weight.
Time frame: Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.
Change in binge eating frequency
Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire
Time frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Severity of loss of control over eating
Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score
Time frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Change in severity of binge eating
Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire
Time frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Improved metabolic indicators of weight management
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.
Time frame: Baseline, 25 weeks (end) treatment
Change in the levels of depression, anxiety and stress.
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
Time frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Health related quality of life
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
Time frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo