NCT02464345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

July 7, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

December 27, 2021

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

June 1, 2015

Last Update Submit

December 23, 2021

Conditions

Binge Eating DisorderBulimia NervosaEating Disorder

Keywords

BEDBinge Eating DisorerBNBulimia NervosaObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in binge eating frequency

    Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.

  • Severity of loss of control over eating

    Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.

  • Change in severity of binge eating

    Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.

  • Improved metabolic indicators of weight management

    Baseline, 25 weeks (end) treatment

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

HAPIFED

EXPERIMENTAL

HAPIFED therapy

Behavioral: HAPIFED

CBT-E

ACTIVE COMPARATOR

CBT-E therapy

Behavioral: CBT-E

Interventions

HAPIFEDBEHAVIORAL

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).

HAPIFED
CBT-EBEHAVIORAL

CBT-E therapy

CBT-E

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)
  • BMI between ≥ 27 and \< 40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo (UNIFESP)

São Paulo, São Paulo, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 28304341BACKGROUND

  • 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.

    PMID: 26683478BACKGROUND

  • 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.

    PMID: 30428611BACKGROUND

  • 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.

    PMID: 35610603DERIVED

  • 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.

    PMID: 31983019DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderBulimia NervosaFeeding and Eating DisordersObesity

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Angelica Claudino, MD, Ph.D

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

July 7, 2015

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

December 27, 2021

Record last verified: 2019-07

Locations

BR(1)