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

Federal University of São Paulo

Status: Completed

Conditions: Eating Disorder; Bulimia Nervosa; Binge Eating Disorder

Treatments: Behavioral: HAPIFED; Behavioral: CBT-E

Study type: Interventional

Funder types: Other

Identifiers

NCT02464345

88881.068180/2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

HAPIFED

Experimental group

Description:

HAPIFED therapy

Treatment:

Behavioral: HAPIFED

CBT-E

Active Comparator group

Description:

CBT-E therapy

Treatment:

Behavioral: CBT-E