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

Study Overview
=================
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.

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.

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.

Conditions
-----------------
Binge Eating Disorder, Bulimia Nervosa, Eating Disorder

Intervention / Treatment
-----------------
* Behavioral: HAPIFED
* Behavioral: CBT-E


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAPIFED<br>HAPIFED therapy | Behavioral: HAPIFED<br>* 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).<br>|
| Active Comparator: CBT-E<br>CBT-E therapy | Behavioral: CBT-E<br>* CBT-E therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in binge eating frequency | Change (for less) in binge eating frequency as measured on the Eating Disorder Examintaion Questionnaire | Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. | 
| Severity of loss of control over eating | Change (for less) in the Global (total) Loss of Control over Eating Scale (LOCES) score | Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. | 
| Change in severity of binge eating | Binge eating severity as measured by a reduced total score on the Binge Eating Scale questionnaire | Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. | 
| 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. | Baseline, 25 weeks (end) treatment | 
| 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 | Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. | 
| 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 | Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Binge Eating Disorer, Bulimia Nervosa, Obesity, BED, BN