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Virtual Body Project Groups Led by Peers Versus Clinicians

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05993728
Acronym
v-BP
Enrollment
441
Registered
2023-08-15
Start date
2024-02-15
Completion date
2029-12-31
Last updated
2025-12-12

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

Conditions

Body Image, Eating Disorders

Keywords

Prevention, Body acceptance

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).

Interventions

BEHAVIORALBody Project

The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.

Participants randomized to the educational control condition will receive videos addressing body image and eating disorders

Sponsors

Karolinska Institutet
CollaboratorOTHER
Stanford University
CollaboratorOTHER
Oslo New University College, Norway
CollaboratorUNKNOWN
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Ongoing eating disorder diagnosis requiring treatment or hospitalization

Design outcomes

Primary

MeasureTime frameDescription
Change over time in eating disorder symptomsBaseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-yearsAssessed 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 onsetBaseline/pretest, 1-year, and at 2-yearsAssessed 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.
Change over time in Body dissatisfactionBaseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-yearsAssessed 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 internalizationBaseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-yearsAssessed 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.
Negative affectBaseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years20 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

MeasureTime frameDescription
Change over time in appearance ideals and perceived pressuresBaseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-yearsAssessed 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026