Virtual Body Project Groups Led by Peers Versus Clinicians

NCT ID: NCT05993728

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2029-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Eating Disorders Body Image

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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Clinician-led Body Project

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

Group Type EXPERIMENTAL

Body Project

Intervention Type BEHAVIORAL

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

Peer-led Body Project

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

Group Type EXPERIMENTAL

Body Project

Intervention Type BEHAVIORAL

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

Educational control

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

Group Type ACTIVE_COMPARATOR

Psychoeducational control

Intervention Type BEHAVIORAL

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

Interventions

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Body Project

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

Intervention Type BEHAVIORAL

Psychoeducational control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Ongoing eating disorder diagnosis requiring treatment or hospitalization
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Oslo New University College, Norway

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Line Wisting

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Line Wisting, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 38001544 (View on PubMed)

Other Identifiers

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609734

Identifier Type: -

Identifier Source: org_study_id

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