Virtual Body Project Groups Led by Peers Versus Clinicians

NCT05993728 | Active Not Recruiting DMC

• 1 other identifier: 609734
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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).

Conditions

Body Image; Eating Disorders

Keywords

Prevention; Body acceptance

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• 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 Arms (3)

Clinician-led Body Project

EXPERIMENTAL

Participants randomized to this condition will take part in virtual Body Project groups led by clinicians.

Behavioral: Body Project

Peer-led Body Project

EXPERIMENTAL

Participants randomized to this condition will take part in virtual Body Project groups led by peers.

Behavioral: Body Project

Educational control

ACTIVE COMPARATOR

Participants randomized to the educational control group will receive educational videos on body image and eating disorders

Behavioral: Psychoeducational control

Interventions

Body Project BEHAVIORAL

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

Clinician-led Body Project; Peer-led Body Project

Psychoeducational control BEHAVIORAL

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

Educational control

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Female-identifying
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Ongoing eating disorder diagnosis requiring treatment or hospitalization

Sponsors & Collaborators

• Karolinska Institutet: collaborator
• Stanford University: collaborator
• Oslo New University College, Norway: collaborator
• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Wisting L, Stice E, Ghaderi A, Dahlgren CL. Effectiveness of virtually delivered Body Project groups to prevent eating disorders in young women at risk: a protocol for a randomized controlled trial. J Eat Disord. 2023 Nov 24;11(1):209. doi: 10.1186/s40337-023-00932-7.

  PMID: 38001544 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Line Wisting, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 15, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)