Eating DisordersNCT05794763
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
A study testing Peer Led Group Intervention in people with Eating Disorders, run by Stanford University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Peer Led Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2022to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University
Palo Alto, California, 94306
St. Mary's College of Maryland
Saint Marys City, Maryland, 20686
About this study
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.
Read the 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.
- Conditions
- Eating Disorders
- Being tested
- Peer Led Group Intervention
- Keywords
- Prevention, Peer Leader, Feeding and Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Led Group InterventionBehavioural
Also called Body Project
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
| Study group | Role | What they receive |
|---|---|---|
| Body Project: In Person Delivery | Experimental | 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. Receives: Behavioral: Peer Led Group Intervention |
| Body Project: Virtual Delivery | Experimental | 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. Receives: Behavioral: Peer Led Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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.
Measured: 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
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.
Measured: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Secondary outcomes (9)
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. 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.
Measured: 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
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.
Measured: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
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. 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.
Measured: 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
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.
Measured: Pre intervention obtained on intake, and immediately post intervention.
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.
Measured: Pre intervention obtained on intake, and immediately post intervention.
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.
Measured: 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
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.
Measured: Pre intervention and 3 months after the end of the intervention.
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.
Measured: Pre intervention obtained on intake, and immediately post intervention.
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.
Measured: Pre intervention obtained on intake, and immediately post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start31 Mar 2022
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Stice, Stanford University
- Investigators
- Eric Stice, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794763
- Sponsor's protocol ID
- 64138
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2023
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
- ClinicalTrials.gov ID
- NCT05794763
- Acronym / sponsor ID
- 64138
- Conditions
- Eating Disorders
- Keywords
- Prevention, Peer Leader, Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Project: In Person Delivery | Experimental | Behavioral: Peer Led Group InterventionIn 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. |
| Body Project: Virtual Delivery | Experimental | Behavioral: Peer Led Group InterventionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Led Group InterventionAlso: Body ProjectA 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 | Behavioural | Body Project: In Person Delivery, Body Project: Virtual Delivery |
Primary outcome
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.
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.
9 secondary outcomes
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)
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)
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)
Change Over Time in Social Appearance Anxiety
Time frame: 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.
Change Over Time in Self-Stigma of Seeking Help Scale
Time frame: 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.
Body Project Specific Attitude Measures
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Stice, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Led Group Intervention in people with Eating Disorders, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.