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Randomized Controlled Trial of Project Body Neutrality

Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06172452
Enrollment
220
Registered
2023-12-15
Start date
2023-12-07
Completion date
2024-07-18
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Image, Depression, Eating Disorders

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.

Interventions

BEHAVIORALProject Body Neutrality SSI

Online, 30-minute self-guided intervention for youth ages 13-17

Online, 30-minute self-guided activity for youth ages 13-17

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Participants will be randomized to either the intervention condition or the supportive therapy control.

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)Pre-Intervention to 3-month follow-upA 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-upA 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

MeasureTime frameDescription
Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks 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.
State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks 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.
Functionality Appreciation Scale (FAS; Alleva et al., 2017)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks 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.
Body Image States Scale (BISS; Cash et al., 2002)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks 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.

Other

MeasureTime frameDescription
Comprehensive Inventory of Mindfulness Experiences for Adolescents - Accepting with Nonjudgmental Orientation Subscale (CHIME-A; Johnson et al., 2017)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks respondents to rate three items from 1 (Almost Never) to 6 (Almost Always). Total scores range from 3 to 18 with higher scores indicating greater nonjudgmental acceptance. We adapted the items of this subscale to ask specifically about nonjudgmental acceptance of one's physical appearance.
Muscle Dysmorphic Disorder Inventory (MDDI; Hildebrandt et al., 2004)Pre-Intervention to 3-month follow-upAsks respondents to rate thirteen items from 1 (Never) to 5 (Always). Total scores range from 13 to 65 with higher scores reflecting a greater severity of muscle dysphoria symptoms.
Program Feedback Scale (PFS; Schleider et al., 2019)Immediately Post-InterventionAsks respondents to rate seven statements regarding intervention acceptability and feasibility; it also includes open-ended items that invite respondents to share what they liked and/or would change about the intervention. The seven statements are rated from 1 (Really Disagree) to 5 (Really Agree). Total score ranges from 5 to 35, with higher scores indicating a more positive evaluation.
Treatment seeking questions3-month follow-upRespondents are asked two questions about mental health treatment seeking in the past three months: In the past 3 months (since completing the first survey for this study), did you seek out any new support for depression or mood problems? and In the past 3 months (since completing the first survey for this study), did you seek out any new support for an eating disorder or body image problems?
Body Image Acceptance and Action Questionnaire (BI-AAQ; Sandoz et al., 2013)Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-upAsks respondents to rate twelve items from 1 (Never True) to 7 (Always True). Total scores range from 12 to 84, with higher scores indicating greater body image flexibility.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026