search
Back to results

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

Primary Purpose

Eating Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Led Group Intervention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Prevention, Peer Leader, Feeding and Eating Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University
  • St. Mary's College of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Body Project: In Person Delivery

Body Project: Virtual Delivery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change over time in Body Dissatisfaction
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.
Change over time in Thin Ideal Internalization
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

Change over time in Negative Affect
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.
Change over time in Dieting
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.
Body Comparison Orientation
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.
Change over time in Social Appearance Anxiety
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.
Change over time in Body Compassion
The 10-item Body Appreciation Scale-2 will assess levels of body compassion using a response scale ranging from 1 = never to 5 = always.
Change over time in Self-Stigma of Seeking Help Scale
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.
Change over time in Eating Disorder symptoms
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.
Body Project Specific Attitude Measures
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.
Body Project Specific Outcome Measures
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.

Full Information

First Posted
March 20, 2023
Last Updated
March 20, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT05794763
Brief Title
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
Official Title
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Prevention, Peer Leader, Feeding and Eating Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor at the 3-month follow-up is blind to participant randomization.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body Project: In Person Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Body Project: Virtual Delivery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Led Group Intervention
Other Intervention Name(s)
Body Project
Intervention Description
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
Primary Outcome Measure Information:
Title
Change over time in Body Dissatisfaction
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Thin Ideal Internalization
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Secondary Outcome Measure Information:
Title
Change over time in Negative Affect
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Dieting
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Body Comparison Orientation
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Social Appearance Anxiety
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Body Compassion
Description
The 10-item Body Appreciation Scale-2 will assess levels of body compassion using a response scale ranging from 1 = never to 5 = always.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Self-Stigma of Seeking Help Scale
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Change over time in Eating Disorder symptoms
Description
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.
Time Frame
Pre intervention and 3 months after the end of the intervention.
Title
Body Project Specific Attitude Measures
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.
Title
Body Project Specific Outcome Measures
Description
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.
Time Frame
Pre intervention obtained on intake, and immediately post intervention.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All gender identities besides cisgender and transgender men were eligible.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
St. Mary's College of Maryland
City
Saint Marys City
State/Province
Maryland
ZIP/Postal Code
20686
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs