The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05794763
Collaborator
(none)
80
2
2
16
40
2.5

Study Details

Study Description

Brief Summary

This present study will compare the efficacy of in-person versus virtually-delivered Body Project groups. It will also evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population. It will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Led Group Intervention
N/A

Detailed Description

Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. The proposed study will evaluate the effectiveness of a peer-implemented, virtually delivered, body acceptance class compared to a peer-implemented, in-person delivery of the same class. Participation in the intervention will last four weeks. Participants will be randomly assigned to the in-person or virtual body acceptance class. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcomes assessor at the 3-month follow-up is blind to participant randomization.
Primary Purpose:
Prevention
Official Title:
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
Actual Study Start Date :
Mar 31, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Body Project: In Person Delivery

In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.

Behavioral: Peer Led Group Intervention
A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
Other Names:
  • Body Project
  • Experimental: Body Project: Virtual Delivery

    In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.

    Behavioral: Peer Led Group Intervention
    A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
    Other Names:
  • Body Project
  • Outcome Measures

    Primary Outcome Measures

    1. Change over time in Body Dissatisfaction [Pre intervention obtained on intake, and immediately post intervention.]

      Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied.

    2. Change over time in Thin Ideal Internalization [Pre intervention obtained on intake, and immediately post intervention.]

      The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.

    Secondary Outcome Measures

    1. Change over time in Negative Affect [Pre intervention obtained on intake, and immediately post intervention.]

      Twenty items from the sadness, guilt, and fear/anxiety subscales from the Positive Affect and Negative Affect Scale-Revised will assess negative affect. Participants reported the extent to which they had felt negative emotions on scales ranging from 1 = very slightly or not at all to 5 = extremely.

    2. Change over time in Dieting [Pre intervention obtained on intake, and immediately post intervention.]

      The 10-item Dutch Restrained Eating Scale will assess the frequency of dieting behaviors using a response scale ranging from 1 = never to 5 = always.

    3. Body Comparison Orientation [Pre intervention obtained on intake, and immediately post intervention.]

      The six selected items from the Body, Eating, and Exercise Comparison Orientation Scale will assess the frequency of body comparisons using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.

    4. Change over time in Social Appearance Anxiety [Pre intervention obtained on intake, and immediately post intervention.]

      The 16-item Social Appearance Anxiety Scale will assess levels of social appearance anxiety using a response scale ranging from 1 = not at all to 5 = extremely.

    5. Change over time in Body Compassion [Pre intervention obtained on intake, and immediately post intervention.]

      The 10-item Body Appreciation Scale-2 will assess levels of body compassion using a response scale ranging from 1 = never to 5 = always.

    6. Change over time in Self-Stigma of Seeking Help Scale [Pre intervention obtained on intake, and immediately post intervention.]

      The 10-item Self-Stigma of Seeking Help Scale will assess participants' views towards seeking help using a scale ranging from 1 = strongly disagree to 5 = strongly agree.

    7. Change over time in Eating Disorder symptoms [Pre intervention and 3 months after the end of the intervention.]

      Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.

    8. Body Project Specific Attitude Measures [Pre intervention obtained on intake, and immediately post intervention.]

      7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.

    9. Body Project Specific Outcome Measures [Pre intervention obtained on intake, and immediately post intervention.]

      7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria: Participants had to express body image concerns and all gender identities besides cisgender and transgender men were eligible.

    Exclusion Criteria:
    • Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Palo Alto California United States 94306
    2 St. Mary's College of Maryland Saint Marys City Maryland United States 20686

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Eric Stice, PhD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric Stice, Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05794763
    Other Study ID Numbers:
    • 64138
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 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 Eric Stice, Professor, Stanford University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 3, 2023