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

Primary Purpose

Eating Disorders, Body Image

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Body Project
Psychoeducational control
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Prevention, Body acceptance

Eligibility Criteria

16 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age 16-25 Female identifying Self-reported body image concerns Exclusion Criteria: Ongoing eating disorder diagnosis requiring treatment or hospitalization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Clinician-led Body Project

    Peer-led Body Project

    Educational control

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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
    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.
    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
    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.
    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Oslo University Hospital
    Collaborators
    Karolinska Institutet, Stanford University, Oslo New University College, Norway
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05993728
    Brief Title
    Virtual Body Project Groups Led by Peers Versus Clinicians
    Acronym
    v-BP
    Official Title
    Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    Karolinska Institutet, Stanford University, Oslo New University College, Norway

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders, Body Image
    Keywords
    Prevention, Body acceptance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)
    Allocation
    Randomized
    Enrollment
    441 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinician-led Body Project
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this condition will take part in virtual Body Project groups led by clinicians.
    Arm Title
    Peer-led Body Project
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this condition will take part in virtual Body Project groups led by peers.
    Arm Title
    Educational control
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to the educational control group will receive educational videos on body image and eating disorders
    Intervention Type
    Behavioral
    Intervention Name(s)
    Body Project
    Intervention Description
    The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducational control
    Intervention Description
    Participants randomized to the educational control condition will receive videos addressing body image and eating disorders
    Primary Outcome Measure Information:
    Title
    Change over time in eating disorder symptoms
    Description
    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
    Time Frame
    Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
    Title
    Rate of eating disorder onset
    Description
    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.
    Time Frame
    Baseline/pretest, 1-year, and at 2-years
    Title
    Change over time in Body dissatisfaction
    Description
    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
    Time Frame
    Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
    Title
    Change over time in thin-ideal internalization
    Description
    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.
    Time Frame
    Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
    Title
    Negative affect
    Description
    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
    Time Frame
    Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
    Secondary Outcome Measure Information:
    Title
    Change over time in appearance ideals and perceived pressures
    Description
    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
    Time Frame
    Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female-identifying
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 16-25 Female identifying Self-reported body image concerns Exclusion Criteria: Ongoing eating disorder diagnosis requiring treatment or hospitalization
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Line Wisting, PhD
    Phone
    +4793495268
    Email
    uxwili@ous-hf.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Line Wisting, PhD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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