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
About this trial
This is an interventional prevention trial for Eating Disorders focused on measuring Prevention, Body acceptance
Eligibility Criteria
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
NCT ID
NCT05993728
First Posted
July 31, 2023
Last Updated
August 8, 2023
Sponsor
Oslo University Hospital
Collaborators
Karolinska Institutet, Stanford University, Oslo New University College, Norway
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
Learn more about this trial
Virtual Body Project Groups Led by Peers Versus Clinicians
We'll reach out to this number within 24 hrs