NCT05559944

Brief Summary

Sexual minority (SM; e.g., gay, lesbian, bisexual, pansexual, queer) young adults are at elevated risk for eating disorders (EDs). Researchers have used minority stress theory to understand how increased risk is due, in part, to stigma and discrimination from being part of a marginalized group. Despite this glaring inequity, limited programs exist to prevent EDs in SM populations. Critically, many SM young people live in rural regions with high anti-LGBTQ+ stigma and limited access to SM-specific resources. The proposed project will address this gap by adapting and evaluating two brief online interventions to reduce ED risk. N = 120 SM young adults in rural regions of Alabama with high LGBTQ+ stigma and low SM-specific resources will be randomized into one three brief online writing interventions: 1) expressive writing (n = 40), 2) self-affirmation (n = 40), or 3) control (n = 40). Participants will complete assessments pre-intervention, post-intervention, and 1-month post-intervention. Aim 1 will assess intervention feasibility and acceptability. Aim 2 will compare the brief online writing interventions to control in improving body image and ED symptoms. Finally, an exploratory aim will examine posited intervention mechanisms and whether the level of SM stigma and discrimination participants experience pre-intervention impacts intervention efficacy. This research will help support and benefit underserved SM young adults by filling a critical need for brief, scalable interventions that can be delivered online to help reduce ED risk. Data from this project will serve as pilot data for a subsequent R-series grant application from NIH.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

September 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 19, 2022

Last Update Submit

January 29, 2024

Conditions

Keywords

LGBTQIA+Body ImageAlabamaEating Disorders

Outcome Measures

Primary Outcomes (2)

  • Body Image

    Body Image States Scale (BISS); 7-item self-report measure about satisfaction with overall appearance. Scores range from 1-9, with higher scores reflecting more positive body image

    changes from baseline through 1-month follow-up

  • Eating Disorder Symptoms

    Eating Pathology Symptom Inventory (EPSI); 45-item measure that assesses 8 domains of eating disorder pathology, scores range from 0-32, with higher scores indicating greater pathology

    changes from baseline through 1-month follow-up

Secondary Outcomes (7)

  • Internalization of Appearance Ideals and Pressures

    changes from baseline through 1-month follow-up

  • Negative Affect

    changes from baseline through 1-month follow-up

  • Interpersonal Emotion Regulation

    changes from baseline through 1-month follow-up

  • Health-related quality of life

    changes from baseline through 1-month follow-up

  • Social Self-Esteem

    changes from baseline through 1-month follow-up

  • +2 more secondary outcomes

Other Outcomes (7)

  • Coping Self-Efficacy

    Baseline

  • Discrimination

    Baseline

  • Internalized Stigma

    Baseline

  • +4 more other outcomes

Study Arms (3)

Expressive Writing

EXPERIMENTAL

Participants will be asked to write about the biggest body image or eating-related stressor they have experienced as a member of the LGBTQ+ community. A general list of the types of stressors and contexts commonly described will be provided to participants, given that meta-analytic research supports that providing examples enhances the efficacy of expressive writing.

Behavioral: Expressive Writing

Self-Affirmation

EXPERIMENTAL

Participants will respond to one new vignette per day describing a SM young adult experiencing severe body image stress in Alabama. Participants will be asked to write to this person and provide advice based on their own experience as a SM young adult. Vignettes will be identical across participants; however, they will be matched to participants' sexual identity, gender identity, and race/ethnicity.

Behavioral: Self-Affirmation

Control

PLACEBO COMPARATOR

Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.

Behavioral: Control

Interventions

Participants will be asked to write about the biggest body image or eating-related stressor they have experienced as a member of the LGBTQ+ community.

Expressive Writing

Participants will receive one new vignette per day describing a SM young adult experiencing severe body image stress in Alabama. Participants will be asked to write to this person and provide advice based on their own experience as a SM young adult. Vignettes will be identical across participants; however, they will be matched to participants' sexual identity, gender identity, and race/ethnicity.

Self-Affirmation
ControlBEHAVIORAL

Consistent with prior research participants will write about their routine daily activities since waking up for 20 minutes each day, sans emotional content.

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-30
  • identify as SM (gay, lesbian, bisexual, pansexual, or queer)
  • endorse body dissatisfaction
  • currently living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
  • have internet access (either via computer/tablet, mobile phone, or community center\[e.g., library\])

You may not qualify if:

  • meet criteria for an ED, based on self-report screener
  • non-English speaking
  • Lack of internet access
  • Not living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
  • Younger than 18, older than 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jordan Merriweather

    Auburn University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 29, 2022

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Data will be maintained for 5 years following the close of the study. Those interested in learning more about the data can contact the Principal Investigator (tab0110@auburn.edu)