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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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001020370
Acronym
Real Happy
Enrollment
246
Registered
2017-07-14
Start date
2019-07-15
Completion date
2021-07-15
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research study will look at the 'real world' effectiveness of a novel approach to treating overweight/obesity with co-morbid binge eating disorder, bulimia nervosa or other specified feeding and eating disorder by way of the HAPIFED program, which combines behavioural weight loss therapy with enhanced cognitive behaviour therapy. It is hypothesised that the HAPIFED Program will result in an average weight loss of greater than or equal to 5% of body weight in the group overall and in at least 50% of participants. In addition, it will result in a global score on the Eating Disorder Examination Questionnaire (EDE-Q) of less than 1 standard deviation above Australian community norms (i.e. below 2.46) in at least 40% of participants, at 52 weeks after commencement of treatment.

Interventions

This study will look at the 'real world' effectiveness of a novel approach to treating overweight/obesity with co-morbid binge eating disorder, bulimia nervosa or other specified feeding and eating disorder by way of the HAPIFED program. HAPIFED stands for a Healthy APproach to weIght management and Food in Eating Disorders and combines multidisciplinary behavioural weight loss therapy and enhanced cognitive behaviour therapy. HAPIFED will be conducted in groups of up to 10 individuals over 30

This study will look at the 'real world' effectiveness of a novel approach to treating overweight/obesity with co-morbid binge eating disorder, bulimia nervosa or other specified feeding and eating disorder by way of the HAPIFED program. HAPIFED stands for a Healthy APproach to weIght management and Food in Eating Disorders and combines multidisciplinary behavioural weight loss therapy and enhanced cognitive behaviour therapy. HAPIFED will be conducted in groups of up to 10 individuals over 30 sessions of 90 minutes duration, on a weekly basis. The administration of HAPIFED as a treatment will not form a part of this study. Rather, this study will involve the collection of data from consenting individuals who are receiving HAPIFED treatment as recommended by their healthcare professional, regardless of this study. HAPIFED treatment will be administered by a multidisciplinary team of clinical psychologists, counsellors and dietitians. All data will be collected through the use of online questionnaires at baseline, week 30, week 52, week 104 and week 156.

Sponsors

The University of Sydney
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026