The Real Happy Study: a prospective assessment of the real-world effectiveness of the HAPIFED program: a Healthy APproach to weIght management and Food in Eating Disorders
- Conditions
- ObesityBinge Eating DisorderBulimia NervosaDiet and Nutrition - ObesityMental Health - Eating disorders
- Registration Number
- ACTRN12617001020370
- Lead Sponsor
- The University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 246
Males and females aged 18 years and over with a BMI of greater than or equal to 25 kg/m2
Must have a global score on the Eating Disorder Examination Questionnaire that is greater than 1 standard deviation (1.25) above the Australian community norm of 1.52 (i.e. above 2.77).
Pregnant or breast-feeding, or having a desire to become pregnant during the first 52 weeks of the study.
Receiving current treatment with a weight loss medication. eg: orlistat, phentermine, liraglutide, or treatment in the 5 weeks prior to screening.
Undergone bariatric surgery or intragastric balloon insertion in the 24 months prior to screening.
No greater than 3kg weight change in the 5 weeks preceding screening.
Received psychotherapy for treatment of an eating disorder in the 5 weeks preceding screening.
Diagnosis of a clinical condition that interferes with appetite regulation. eg: Prader-Willi or Cushing's syndrome.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of participants who have lost greater than or equal to 5% of their baseline body weight.[At 52 weeks following the commencement of treatment.];The proportion of participants who have a global score on the EDE-Q that is less than 1 standard deviation above Australian community norms (i.e. below 2.77).[At 52 weeks following the commencement of treatment.]
- Secondary Outcome Measures
Name Time Method