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

NCT ID: NCT02464345

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-07

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Binge Eating Disorder Bulimia Nervosa Eating Disorder

Keywords

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BED Binge Eating Disorer BN Bulimia Nervosa Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HAPIFED

HAPIFED therapy

Group Type EXPERIMENTAL

HAPIFED

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

CBT-E

Intervention Type BEHAVIORAL

CBT-E therapy

Interventions

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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).

Intervention Type BEHAVIORAL

CBT-E

CBT-E therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Sydney

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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ANGELICA CLAUDINO

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelica Claudino, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Universidade Federal de Sao Paulo (UNIFESP)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 28304341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26683478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30428611 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35610603 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31983019 (View on PubMed)

Other Identifiers

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88881.068180/2014-01

Identifier Type: -

Identifier Source: org_study_id