Randomized Controlled Trial of Project Body Neutrality

Not Applicable

Recruiting

• Conditions: Body Image; Depression; Eating Disorders

• Registration Number: NCT06172452
• Lead Sponsor: Northwestern University

Brief Summary

This study tests a single-session intervention (SSI) targeting risk factors for depression and eating disorders among sexual and gender minority (SGM) adolescents. Youth ages 13-17 who identify as sexual or gender minorities will be randomized to the intervention condition (Project Body Neutrality SSI) or a control (supportive therapy SSI). Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project Body Neutrality leads to reductions in depression and eating disorder symptoms compared to the control.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Identify as a sexual or gender minority individual per self-report
• 13-17 years old at the time of enrollment
• English proficiency per self-report
• Report having body image concerns per self-report
• Score of ≥ 2 on the Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003), - indicating elevated depressive symptoms
• Did not participate in a past study involving Project Body Neutrality per self-report
• Residing within the United States per IP address
• Passes comprehension of consent language assessment

Exclusion Criteria

• Fail to meet the above-listed inclusion criteria
• Exit the study prior to condition randomization
• Failure to pass the data integrity measures
• Duplicate responses from the same individual in baseline or follow-up surveys

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)	Pre-Intervention to 3-month follow-up	A 10-item questionnaire designed to assess the range and severity of features associated with a diagnosis of eating disorder. The original measure's factor structure has failed to replicate across many samples, especially for diverse populations. This version has achieved strict invariance by gender and race/ethnicity. Higher global scores indicate greater eating disorder severity (primary outcome). Outcomes for the three subscales (Dietary Restaurant, Preoccupation with Eating Concern, and Shape/Weight Overvaluation) will also be reported. Each item is on a 0 to 6 scale and the scores are computed as means.
Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)	Pre-Intervention to 3-month follow-up	A 13-item questionnaire designed to assess depressive symptoms in youth. Total scores range from 0 to 26, with higher scores indicating greater depression severity (primary outcome).

Secondary Outcome Measures

Name	Time	Method
State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996)	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up	Asks respondents to rate three statements from 1 (Definitely False) to 8 (Definitely True). Total score ranges from 3 to 24, with higher scores reflecting greater perceived ability to identify goal-oriented routes.
Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013)	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up	Asks respondents to rate four statements reflecting their sense of hopelessness from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total scores range from 0 to 12, with higher scores indicating greater levels of hopelessness.
Body Image States Scale (BISS; Cash et al., 2002)	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up	Asks respondents to rate six items from 1 (poor body image state) to 9 (favorable body image state). Total scores range from 6 to 54, where higher scores indicate a more favorable body image state.
Functionality Appreciation Scale (FAS; Alleva et al., 2017)	Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up	Asks respondents to rate seven statements from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 7 to 35, where higher scores indicate greater appreciation for body functionality.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States