Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED)

Bulimia Nervosa Clinical Trial

— HAPIFED  

Official title:

A Randomised Controlled Trial of a New Integrated Approach to Management of Eating and Weight Disorders, Namely a Healthy APproach to weIght Management and Food in Eating Disorders Compared to Cognitive Behaviour Therapy Enhanced.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464345
• Other study ID #: 88881.068180/2014-01
• Status: Completed
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)

• BMI between = 27 and < 40

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Behavioral:
• HAPIFED
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
CBT-E therapy

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo (UNIFESP)	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	University of Western Sydney

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Palavras MA, Hay P, Claudino A. An Investigation of the Clinical Utility of the Proposed ICD-11 and DSM-5 Diagnostic Schemes for Eating Disorders Characterized by Recurrent Binge Eating in People with a High BMI. Nutrients. 2018 Nov 13;10(11). pii: E1751. doi: 10.3390/nu10111751. — View Citation

Palavras MA, Hay P, Filho CA, Claudino A. The Efficacy of Psychological Therapies in Reducing Weight and Binge Eating in People with Bulimia Nervosa and Binge Eating Disorder Who Are Overweight or Obese-A Critical Synthesis and Meta-Analyses. Nutrients. 2017 Mar 17;9(3). pii: E299. doi: 10.3390/nu9030299. Review. — View Citation

Palavras MA, Hay P, Touyz S, Sainsbury A, da Luz F, Swinbourne J, Estella NM, Claudino A. Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial. Trials. 2015 Dec 18;16:578. doi: 10.1186/s13063-015-1079-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.
Secondary	Change in binge eating frequency	Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Secondary	Severity of loss of control over eating	Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Secondary	Change in severity of binge eating	Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Secondary	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.	Baseline, 25 weeks (end) treatment
Secondary	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	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
Secondary	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	Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.