Clinical Trials Directory

Trials / Completed

CompletedNCT02464345

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

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHAPIFEDHAPIFED 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).
BEHAVIORALCBT-ECBT-E therapy

Timeline

Start date
2015-07-07
Primary completion
2019-03-31
Completion
2019-03-31
First posted
2015-06-08
Last updated
2021-12-27

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02464345. Inclusion in this directory is not an endorsement.

Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED) (NCT02464345) · Clinical Trials Directory