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NCT Number: NCT02464345

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

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.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Body Weight Bulimia Nervosa Eating Disorder Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Sao Paulo (UNIFESP)

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAPIFED

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

Behavioral

CBT-E therapy

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.

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

    Change of 5% of body weight.

Secondary outcomes

  1. Change in binge eating frequency

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

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

  2. 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.

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

  3. Change in severity of binge eating

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

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

  4. Improved metabolic indicators of weight management

    Time frame: Baseline, 25 weeks (end) treatment

    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.

  5. 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.

    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

  6. Health related quality of life

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

    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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • University of Western Sydney

Registry information

Official study 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.

Acronym: HAPIFED

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2015
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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