- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464345
Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED) (HAPIFED)
December 23, 2021 updated by: ANGELICA CLAUDINO, Federal University of São Paulo
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Sao Paulo, SP, Brazil
- Universidade Federal de São Paulo (UNIFESP)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HAPIFED
HAPIFED therapy
|
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).
|
Active Comparator: CBT-E
CBT-E therapy
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CBT-E therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes.
Time Frame: Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.
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Change of 5% of body weight.
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Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in binge eating frequency
Time Frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire
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Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Severity of loss of control over eating
Time Frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score
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Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Change in severity of binge eating
Time Frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire
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Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Improved metabolic indicators of weight management
Time Frame: Baseline, 25 weeks (end) treatment
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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.
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Baseline, 25 weeks (end) treatment
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Change in the levels of depression, anxiety and stress.
Time Frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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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
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Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Health related quality of life
Time Frame: Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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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
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Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Angelica Claudino, MD, Ph.D, Federal University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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):299. doi: 10.3390/nu9030299.
- 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.
- 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):1751. doi: 10.3390/nu10111751.
- Hay P, Palavras MA, da Luz FQ, Dos Anjos Garnes S, Sainsbury A, Touyz S, Appolinario JC, Claudino AM. Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index: a randomized controlled trial. BMC Psychiatry. 2022 May 24;22(1):355. doi: 10.1186/s12888-022-04005-y.
- Palavras MA, Hay P, Mannan H, da Luz FQ, Sainsbury A, Touyz S, Claudino AM. Integrated weight loss and cognitive behavioural therapy (CBT) for the treatment of recurrent binge eating and high body mass index: a randomized controlled trial. Eat Weight Disord. 2021 Feb;26(1):249-262. doi: 10.1007/s40519-020-00846-2. Epub 2020 Jan 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2015
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
June 1, 2015
First Submitted That Met QC Criteria
June 3, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
December 27, 2021
Last Update Submitted That Met QC Criteria
December 23, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 88881.068180/2014-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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