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Clinical Trials/NCT05993728
NCT05993728
Active, not recruiting
Not Applicable

Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial

Oslo University Hospital1 site in 1 country441 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
Oslo University Hospital
Enrollment
441
Locations
1
Primary Endpoint
Change over time in Body dissatisfaction
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
December 31, 2029
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Line Wisting

Principal Investigator

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 16-25
  • Female identifying
  • Self-reported body image concerns

Exclusion Criteria

  • Ongoing eating disorder diagnosis requiring treatment or hospitalization

Outcomes

Primary Outcomes

Change over time in Body dissatisfaction

Time Frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years

Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction

Change over time in thin-ideal internalization

Time Frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years

Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.

Change over time in eating disorder symptoms

Time Frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years

Assessed with the 28-item self-report Eating Disorder Examination Questionnaire (EDE-Q). Responses range from 0-6, whith higher scores indicating more severe eating disorder psychopathology

Rate of eating disorder onset

Time Frame: Baseline/pretest, 1-year, and at 2-years

Assessed with the eating disorder diagnostic interview Eating Disorder Assessment-5 (EDA-5). This is a semi-structured clinician-led diagnostic interview, based on the diagnostic criteria in the diagnostic manual DSM-5, and is efficient to determine eating disorder diagnostic status. This outcome will be used to determine proportion of participants with an eating disorder diagnosis.

Negative affect

Time Frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years

20 negative items from the Positive and Negative Affect Schedule - Revised (PANAS-X) (Watson \& Clark, 1992) to measure negative affect. Higher scores indicate higher levels of negative affect. Responses range from 1-5

Secondary Outcomes

  • Change over time in appearance ideals and perceived pressures(Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years)

Study Sites (1)

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