v-BP: Virtual Body Project Groups Led by Peers Versus Clinicians

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05993728
Collaborator
Karolinska Institutet (Other), Stanford University (Other), Oslo New University College, Norway (Other)
441
3
52

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Body Project
  • Behavioral: Psychoeducational control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
441 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)
Primary Purpose:
Prevention
Official Title:
Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clinician-led Body Project

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

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

Experimental: Peer-led Body Project

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

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

Active Comparator: Educational control

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

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

Outcome Measures

Primary Outcome Measures

  1. Change over time in eating disorder symptoms [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

  2. Rate of eating disorder onset [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.

  3. Change over time in 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]

    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

  4. Change over time in thin-ideal internalization [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.

  5. Negative affect [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 Outcome Measures

  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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oslo University Hospital
  • Karolinska Institutet
  • Stanford University
  • Oslo New University College, Norway

Investigators

  • Principal Investigator: Line Wisting, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Line Wisting, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05993728
Other Study ID Numbers:
  • 609734
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Line Wisting, Principal Investigator, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023