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Binge Eating DisorderHAPIFEDNCT02464345

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

A study testing HAPIFED and CBT-E in people with Binge Eating Disorder and Bulimia Nervosa, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
HAPIFED and CBT-E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteBrazil
Study dates
7 Jul 2015to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal de Sao Paulo (UNIFESP)

    São Paulo, São Paulo

Other trials in Brazil

About this study

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.

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.

Read the 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.

Being tested
HAPIFED, CBT-E
Keywords
BED, Binge Eating Disorer, BN, Bulimia Nervosa, Obesity
Medical subject headings
Binge-Eating Disorder, Bulimia Nervosa, Feeding and Eating Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAPIFEDBehavioural

    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-EBehavioural

    CBT-E therapy

Study groups in NCT02464345
Study groupRoleWhat they receive
HAPIFEDExperimentalHAPIFED therapy
Receives: Behavioral: HAPIFED
CBT-EActive comparatorCBT-E therapy
Receives: Behavioral: CBT-E

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.

Secondary outcomes (6)

  1. Change in binge eating frequency

    Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire

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

  2. Severity of loss of control over eating

    Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score

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

  3. Change in severity of binge eating

    Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire

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

  4. 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.

    Measured: Baseline, 25 weeks (end) treatment

  5. 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

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

  6. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study start7 Jul 2015
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02464345
Sponsor's protocol ID
88881.068180/2014-01
Acronym
HAPIFED
Status last verified
Jul 2019
First submitted
1 Jun 2015
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28304341

  • 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.

    PubMed 26683478

  • 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.

    PubMed 30428611

  • 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.

    PubMed 35610603

  • 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.

    PubMed 31983019

Questions about this trial

What is this clinical trial studying?

A study testing HAPIFED and CBT-E in people with Binge Eating Disorder and Bulimia Nervosa, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02464345, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.

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