Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000650493
Ethics application status
Approved
Date submitted
4/05/2016
Date registered
19/05/2016
Date last updated
19/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention Across the Spectrum: A randomized-controlled trial of three programs to reduce risk factors for both eating disorders and obesity
Scientific title
Prevention Across the Spectrum: A randomized-controlled trial of three programs to reduce risk factors for both eating disorders and obesity
Secondary ID [1] 289132 0
Nil known
Universal Trial Number (UTN)
Nil Known
Trial acronym
PAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 298618 0
obesity 298619 0
Condition category
Condition code
Mental Health 298694 298694 0 0
Eating disorders
Diet and Nutrition 298695 298695 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three school-based programs for students in Grades 7 and 8, where classes were randomly assigned to receive either 1 of the 3 programs or attend their usual classes (control condition). Each program was 8 X 45-minute lessons in duration and was delivered at the rate of 2 lessons per week (i.e., 4-weeks total). Programs were presented by postgraduate clinical psychology students who attended a 6 hour training workshop delivered by the Chief Investigator. Presenters received training in all three programs and were required to deliver each program in order to reduce the likelihood of presenter effects contaminating program outcomes. Each program involved interactive classroom learning activities (e.g., role plays, small group presentations) and involved an accompanying student workbook. The three programs were: 1) Media Smart; 2) Life Smart; and, 3) the Helping, Encouraging, Listening and Protecting Peers Initiative (HELPP). Media Smart targeted media internalisation, a prospectively identified eating disorder risk factor; Life Smart targeted a range of contributors to health including nutrition, physical activity, emotional and social well being. HELPP targeted appearance-based conversations, another identified risk factor for disordered eating.
Intervention code [1] 294644 0
Prevention
Intervention code [2] 294645 0
Behaviour
Comparator / control treatment
Control group is students participating in normal school lessons.
Control group
Active

Outcomes
Primary outcome [1] 298180 0
Weight and shape concern - a 12-item composite scale from the Eating Disorder Examination - Questionnaire.
Timepoint [1] 298180 0
baseline, post-program, 6-month follow-up, 12-month follow-up
Primary outcome [2] 298181 0
Change in body mass index from baseline to 12-month follow-up. Students had health assessments (height, weight and blood pressure) completed in private by two research assistants. Care was taken to ensure that participants were not able to view their measurements in order to protect against any possible iatrogenic effects.
Timepoint [2] 298181 0
baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [1] 323403 0
Body dissatisfaction - Eating Disorder Inventory (EDI: Garner et al., 1983)
Timepoint [1] 323403 0
baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [2] 323650 0
Dieting - Dutch Eating Behaviour Questionnaire – Restraint (Van Strien et al., 1986), 10 items
Timepoint [2] 323650 0
baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [3] 323651 0
Depression - Child Depression Inventory –Short Form (Kovacs, 1992)
Timepoint [3] 323651 0
baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [4] 323652 0
Weight-related peer teasing - McKnight Risk Factor Survey (Shisslak et al., 1999), 8 items
Timepoint [4] 323652 0
Baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [5] 323653 0
Screen time - Growing Up Today Study (GUTS) - Screen time (Field et al., 2003) (Mean weekday and weekend hours: TV, DVD, Internet/Computer, Nintendo/ Playstation), 8 items.
Timepoint [5] 323653 0
Baseline, post-program, 6-month follow-up, 12-month follow-up
Secondary outcome [6] 323654 0
Physical activity - GUTS - Physical activity (Field et al., 2003) (Mean weekday and weekend hours of playing outside, competitive sport, bike riding) 6 items.
Timepoint [6] 323654 0
Baseline, post-program, 6-month follow-up, 12-month follow-up

Eligibility
Key inclusion criteria
No inclusion criteria other than: being a student in Grades 7 or 8 at participating schools and parental consent
Minimum age
11 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Student not wishing to participate or parental consent not received

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models for change in risk factor scores by condition, gender and time, with baseline scores entered as covariate values. Power analysis was based upon the procedures described by Hedeker and colleagues for determining power for longitudinal designs with attrition. The analyses assume a two-tailed alpha of .05, 4 assessment points (baseline, post-program, 6-month follow-up, 12-month follow-up), attrition (or missing data) rates of approximately 5-10% at each time point, and a fixed autoregressive coefficient of .50. An enrolled sample size of 476 per group would provide sufficient power (.80) for detecting an effect size of .17 for group differences and interaction effects on eating disorder and obesity risk factors between the conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2011
Date of last participant enrolment
Anticipated
Actual
4/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1316
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC

Funding & Sponsors
Funding source category [1] 293502 0
Government body
Name [1] 293502 0
SA Health
Country [1] 293502 0
Australia
Funding source category [2] 293562 0
Charities/Societies/Foundations
Name [2] 293562 0
The Butterfly Research Institute
Country [2] 293562 0
Australia
Primary sponsor type
Individual
Name
Dr Simon Wilksch
Address
Research Fellow
School of Psychology, Flinders University
PO Box 2100, Adelaide, SA, 5001.
Country
Australia
Secondary sponsor category [1] 292331 0
None
Name [1] 292331 0
N/A
Address [1] 292331 0
N/A
Country [1] 292331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294946 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 294946 0
Ethics committee country [1] 294946 0
Date submitted for ethics approval [1] 294946 0
04/02/2010
Approval date [1] 294946 0
09/03/2010
Ethics approval number [1] 294946 0
Project 4744

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65594 0
Dr Simon Wilksch
Address 65594 0
School of Psychology, Flinders University
PO Box 2100, Adelaide, SA, 5001.
Country 65594 0
Australia
Phone 65594 0
+61 8 8201 7996
Fax 65594 0
Email 65594 0
[email protected]
Contact person for public queries
Name 65595 0
Simon Wilksch
Address 65595 0
School of Psychology, Flinders University
PO Box 2100, Adelaide, SA, 5001.
Country 65595 0
Australia
Phone 65595 0
+61 8 8201 7996
Fax 65595 0
Email 65595 0
[email protected]
Contact person for scientific queries
Name 65596 0
Simon Wilksch
Address 65596 0
School of Psychology, Flinders University
PO Box 2100, Adelaide, SA, 5001.
Country 65596 0
Australia
Phone 65596 0
+61 8 8201 7996
Fax 65596 0
Email 65596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOutcomes of three universal eating disorder risk reduction programs by participants with higher and lower baseline shape and weight concern.2017https://dx.doi.org/10.1002/eat.22642
N.B. These documents automatically identified may not have been verified by the study sponsor.