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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05993728
Other study ID # 609734
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date December 31, 2027

Study information

Verified date April 2024
Source Oslo University Hospital
Contact Line Wisting, PhD
Phone +4793495268
Email uxwili@ous-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 441
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 25 Years
Eligibility Inclusion Criteria: - Age 16-25 - Female identifying - Self-reported body image concerns Exclusion Criteria: - Ongoing eating disorder diagnosis requiring treatment or hospitalization

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Body Project
The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.
Psychoeducational control
Participants randomized to the educational control condition will receive videos addressing body image and eating disorders

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (4)

Lead Sponsor Collaborator
Oslo University Hospital Karolinska Institutet, Oslo New University College, Norway, Stanford University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change over time in eating disorder symptoms 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 Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Primary Rate of eating disorder onset 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. Baseline/pretest, 1-year, and at 2-years
Primary Change over time in Body dissatisfaction 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 Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Primary Change over time in thin-ideal internalization 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. Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Primary Negative affect 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 Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Secondary Change over time in appearance ideals and perceived pressures Assessed with the Attitudes Towards Appearance Questionnaire (SATAQ-4R) (Schaefer et al., 2017). A total of 31 items are included, and responses range from 1-5. Higher scores indicate higher levels of internalization/pressures Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
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