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

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05794763
• Other study ID #: 64138
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California
United States	St. Mary's College of Maryland	Saint Marys City	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre intervention obtained on intake, and immediately post intervention.
Primary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	Change over time in Eating Disorder symptoms	Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.	Pre intervention and 3 months after the end of the intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.
Secondary	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.	Pre intervention obtained on intake, and immediately post intervention.