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Completed

NCT Number: NCT05794763

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

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.

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Body Project

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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