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

December 12, 2024 updated by: Eric Stice, Stanford University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94306
        • Stanford University
    • Maryland
      • Saint Marys City, Maryland, United States, 20686
        • St. Mary's College of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change Over Time in Body Dissatisfaction
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. The mean score across the items is reported. Overall scores can range from 1 to 6 and a higher score indicate a greater level of body satisfaction.
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Change Over Time in Thin Ideal Internalization
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates a greater level of thin ideal internalization.
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Project Specific Attitude Measures
Time Frame: 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.
Pre intervention obtained on intake, and immediately post intervention.
Body Project Specific Outcome Measures
Time Frame: 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.
Pre intervention obtained on intake, and immediately post intervention.
Change Over Time in Negative Affect
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates a greater level of negative affect.
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Change Over Time in Dieting
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates greater frequency of dieting behaviors.
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Body Comparison Orientation
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates greater frequency of body comparison.
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Change Over Time in Social Appearance Anxiety
Time Frame: 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.
Pre intervention obtained on intake, and immediately post intervention.
Change Over Time in Body Compassion
Time Frame: 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.
Pre intervention obtained on intake, and immediately post intervention.
Change Over Time in Self-Stigma of Seeking Help Scale
Time Frame: 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.
Pre intervention obtained on intake, and immediately post intervention.
Number of Eating Disorder Behaviors (Events) as a Measure of Change Over Time in Eating Disorder Symptoms
Time Frame: Pre intervention and 3 months after the end of the intervention.
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.
Pre intervention and 3 months after the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Stice, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 64138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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