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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Led Group Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: Participants had to express body image concerns and all gender identities besides cisgender and transgender men were eligible.
Exclusion Criteria:
All gender identities besides cisgender and transgender men were eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Stice, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94306 | United States | ||
| St. Mary's College of Maryland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
|
4-week intervention period plus 3-month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Stice | Stanford University | 6507237885 | estice@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2022 | Aug 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2023 | Jul 25, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2022 | Jul 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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The outcomes assessor at the 3-month follow-up is blind to participant randomization.
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Pre intervention obtained on intake, and immediately post intervention. |
| Saint Marys City |
| Maryland |
| 20686 |
| United States |
| BG001 | 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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 |
|
|
| 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. 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. | Posted | Mean | 95% Confidence Interval | scale | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
|
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| 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. 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. | Posted | Mean | 95% Confidence Interval | scale score | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
|
|
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| 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. 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. | Posted | Mean | 95% Confidence Interval | scale score | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
|
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| 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. 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. | Posted | Mean | 95% Confidence Interval | scale score | Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week) |
|
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|
| 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. | Not Posted | Pre intervention obtained on intake, and immediately post intervention. | Participants |
| 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. | Not Posted | Pre intervention obtained on intake, and immediately post intervention. | Participants |
| 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. | Not Posted | Pre intervention obtained on intake, and immediately post intervention. | Participants |
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | events | Pre intervention and 3 months after the end of the intervention. |
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| 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. | Not Posted | Pre intervention obtained on intake, and immediately post intervention. | Participants |
| 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. | Not Posted | Pre intervention obtained on intake, and immediately post intervention. | Participants |
| 0 |
| 33 |
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| 33 |
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| 33 |
| EG001 | 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. 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 | 0 | 36 | 0 | 36 | 0 | 36 |
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