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Trial registered on ANZCTR


Registration number
ACTRN12617001020370
Ethics application status
Approved
Date submitted
29/06/2017
Date registered
14/07/2017
Date last updated
15/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 292160 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Real Happy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 303601 0
Binge Eating Disorder 303602 0
Bulimia Nervosa 303953 0
Condition category
Condition code
Diet and Nutrition 303011 303011 0 0
Obesity
Mental Health 303012 303012 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 298312 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302608 0
The proportion of participants who have lost greater than or equal to 5% of their baseline body weight.
Timepoint [1] 302608 0
At 52 weeks following the commencement of treatment.
Primary outcome [2] 302609 0
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).
Timepoint [2] 302609 0
At 52 weeks following the commencement of treatment.
Secondary outcome [1] 336482 0
The change in absolute weight.
Timepoint [1] 336482 0
Baseline and at weeks 30, 52, 104 and 156 following the commencement of treatment.
Secondary outcome [2] 336483 0
The proportion of participants who achieve greater than or equal to 5% loss of baseline body weight.
Timepoint [2] 336483 0
Baseline and at weeks 30, 104 and 156 following the commencement of treatment.
Secondary outcome [3] 336484 0
The difference in the effect of HAPIFED in relation to the classification of obesity (Class 1,2,3) at baseline.
Timepoint [3] 336484 0
Baseline and at weeks 30, 52, 104 and 156 following the commencement of treatment.
Secondary outcome [4] 336485 0
The proportion of participants who no longer have binge eating disorder, bulimia nervosa or other specified feeding and eating disorder, as assessed using the EDE-Q.
Timepoint [4] 336485 0
Baseline and at weeks 30, 52, 104 and 156 following the commencement of treatment.
Secondary outcome [5] 336486 0
Severity of Eating Disorder using the EDE-Q.
Timepoint [5] 336486 0
At baseline and at weeks 30, 52, 104 and 156 following commencement of treatment.
Secondary outcome [6] 336487 0
Nutritional quality of food choices, including the intake of vegetables, fruit and dairy products, as assessed using the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Healthy Diet Score Survey.
Timepoint [6] 336487 0
At baseline and at weeks 30, 52, 104 and 156 following commencement of treatment.
Secondary outcome [7] 336488 0
Depression, anxiety and stress, as assessed using the 21-item Depression, Anxiety and Stress Scale.
Timepoint [7] 336488 0
At baseline and at weeks 30, 52, 104 and 156 following commencement of treatment.
Secondary outcome [8] 336489 0
Quality of Life using the 12-Item Short Form Health Survey (SF12).
Timepoint [8] 336489 0
At baseline and at weeks 30, 52, 104 and 156 following commencement of treatment.
Secondary outcome [9] 336490 0
Cost Effectiveness of treatment through the use of a specifically designed cost effectiveness and health care utilisation questionnaire.
Timepoint [9] 336490 0
At baseline and at weeks 30, 52, 104 and 156 following commencement of treatment.
Secondary outcome [10] 336762 0
The change in weight as a percentage of body weight.
Timepoint [10] 336762 0
Baseline and at weeks 30, 52, 104 and 156 following the commencement of treatment.
Secondary outcome [11] 336763 0
The change in BMI.
Timepoint [11] 336763 0
Baseline and at weeks 30, 52, 104 and 156 following the commencement of treatment.

Eligibility
Key inclusion criteria
Males and females aged 18 years and over with a BMI of greater than or equal to 25 kg/m2.
Must meet the diagnostic criteria for binge eating disorder, bulimia nervosa or other specified feeding and eating disorder according to the DSM-5.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size was selected based on a published study of a similar design. Attrition is expected to be approximately 50% at study end (156 weeks).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296694 0
Self funded/Unfunded
Name [1] 296694 0
Address [1] 296694 0
Country [1] 296694 0
Primary sponsor type
University
Name
The University of Sydney
Address
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders,
Level 2, Charles Perkins Centre,
John Hopkins Drive,
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 295655 0
Hospital
Name [1] 295655 0
Royal Prince Alfred Hospital
Address [1] 295655 0
Metabolism & Obesity Services
Camperdown, NSW 2050
Country [1] 295655 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297922 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 297922 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
Newtown NSW 2042
Ethics committee country [1] 297922 0
Australia
Date submitted for ethics approval [1] 297922 0
08/06/2017
Approval date [1] 297922 0
11/07/2017
Ethics approval number [1] 297922 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
This study will now be conducted online and participants will be recruited from wherever the HAPIFED program is being implemented.

Contacts
Principal investigator
Name 75470 0
Ms Andrea Pattinson
Address 75470 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders,
Level 2, Charles Perkins Centre,
John Hopkins Drive,
The University of Sydney, NSW 2006
Country 75470 0
Australia
Phone 75470 0
+61 2 8627 1933
Fax 75470 0
Email 75470 0
andrea.pattinson@sydney.edu.au
Contact person for public queries
Name 75471 0
Ms Andrea Pattinson
Address 75471 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders,
Level 2, Charles Perkins Centre,
John Hopkins Drive,
The University of Sydney, NSW 2006
Country 75471 0
Australia
Phone 75471 0
+61 2 8627 1933
Fax 75471 0
Email 75471 0
andrea.pattinson@sydney.edu.au
Contact person for scientific queries
Name 75472 0
Ms Andrea Pattinson
Address 75472 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders,
Level 2, Charles Perkins Centre,
John Hopkins Drive,
The University of Sydney, NSW 2006
Country 75472 0
Australia
Phone 75472 0
+61 2 8627 1933
Fax 75472 0
Email 75472 0
andrea.pattinson@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable