- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07621081
Brief Single-Session Body Neutrality Program for LGBTQ+ Adults in Central Alabama
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eating disorders (EDs) kill one person in the United States every 52 minutes, cost over $65 billion annually ($966 million annually in Alabama (AL) alone), have numerous barriers to treatment access, and are notoriously difficult to treat. Thus, scalable interventions that can target high-risk groups prior to ED onset are critical to reducing both the public health burden and number of people suffering from EDs. Researchers have found that LGBTQ+ adults are at a significantly increased risk for EDs. Further, LGBTQ+ adults who live in rural areas with high levels of anti-LGBTQ+ structural stigma and limited access to LGBTQ+-specific resources may have compounded risk for ED development and reduced access to care. Despite this glaring inequity, few scalable programs exist to prevent EDs in LGBTQ+ populations. Thus, the present study proposes a pilot digital single-session intervention to reduce ED risk for LGBTQ+ adults in a high-stigma, low-resource region of AL.
LGBTQ+ people represent a high-risk group for EDs due to minority stressors. LGBTQ+ individuals have a 2-3 fold increased risk for developing an ED compared to their cisgender heterosexual peers. LGBTQ+ young adults also exhibit higher rates of overall ED symptoms, binge eating, dieting, vomiting, laxative, or diet pill use, muscle-building supplement use, and fasting compared to their non-LGBTQ+ peers. Researchers, using minority stress theory, have identified that increased risk is due, in part, to chronic stressors (e.g., prejudice, victimization, discrimination, internalized homophobia and/or transphobia, sexual identity concealment) due to being part of a marginalized group. These stressors are exacerbated for LGBTQ+ people of Color and those living in poverty. Additionally, LGBTQ+ individuals living in rural areas have increased vulnerability for mental health concerns and EDs. LGBTQ+ adults living in rural areas that have high prevalence of anti-LGBTQ+ structural stigma (e.g., discriminatory laws, policies, and community attitudes that promote unequal treatment) and low access to LGBTQ+-specific coping resources (e.g., LGBTQ+ centers, specialized healthcare) have increased risk for mental health problems compared to their urban peers. Further, individuals living in rural areas of AL, especially rural people of Color, often experience high degrees of medical mistrust due to lack of culturally competent care and history of medical abuse, which further increases disparities in broader health care access and utilization. Given the commonality of EDs in rural areas, high LGBTQ-stigma, and limited resources, LGBTQ+ adults living in rural regions of AL may represent a particularly vulnerable and underserved group for EDs.
Despite consistent research supporting increased ED risk among LGBTQ+ individuals, no ED prevention efforts have targeted minority stressors in rural LGBTQ+ adults, who need these interventions the most. Brief digital single-session intervention that incorporates psychoeducation about minority stress and body neutrality may be efficacious in reducing ED risk and improve positive body image among LGBTQ+ adults in rural areas. A recent randomized controlled trial developed a similar single-session intervention among LGBTQ+ adolescents (13-17 years old) in the United States. This Project Body Neutrality study indicated immediate positive changes in participants' body satisfaction, functionality appreciation, hopelessness, and perceived agency. This study supports the potential of online single-session intervention in addressing LGBTQ+ populations' eating pathology and body image concerns. Importantly, research suggests that the use of community-engaged research methodologies, where members of the community are actively engaged in research study design, development, and implementation, are critical for addressing the needs of minoritized communities and mitigating medical mistrust. Indeed, community-engaged research is a common approach to help reduce health disparities in diverse LGBTQ+ populations and our team has successfully adapted multi-session body image interventions for LGBTQ+ populations (e.g., the PRIDE Body Project) using a community-engaged approach in both rural and urban settings.
The present project evaluates and adapts Project Body Neutrality for LGBTQ+ adults in a rural high-stigma, low-resource region. The proposed study will recruit N = 40 LGBTQ+ adults in central AL to complete our program and pre-intervention and post-intervention assessments. The investigators hypothesize that this intervention program will effectively address LGBTQ+ adults' eating pathology, as well as their experience of minority stress, and improve their positive body image, especially their functionality appreciation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiaoyin Liu Liu
- Phone Number: 334-844-6687
- Email: xil0001@auburn.edu
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36830
- Auburn University
-
Contact:
- Xiaoyin Liu
- Phone Number: 334-844-6687
- Email: xil0001@auburn.edu
-
Principal Investigator:
- Tiffany A Brown, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years old,
- Identify as LGBTQ+,
- 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])
Exclusion Criteria:
- Being less than 18 years old,
- Identifying as cisgender and heterosexual,
- Not living in central AL,
- Not having internet access.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single session body neutrality program
Single session body neutrality program is a brief, 30-minute digital intervention program.
Participants will at first be given a brief introduction to body neutrality and minority stress.
Then, they will be given fictional vignettes of based on common regional examples of body image stressors for LGBTQ+ individuals and practice giving advice to them.
Finally, participants are provided with their customized body neutrality action plan based on their responses during the intervention program.
|
Single session body neutrality program is a brief, 30-minute digital intervention program.
Participants will at first be given a brief introduction to body neutrality and minority stress.
Then, they will be given fictional vignettes of based on common regional examples of body image stressors for LGBTQ+ individuals and practice giving advice to them.
Finally, participants are provided with their customized body neutrality action plan based on their responses during the intervention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functionality Appreciation Scale
Time Frame: baseline and immediately after the intervention
|
Assesses changes in functionality appreciation (7 items, 7-point scale), with higher scores indicating higher levels of functionality appreciation.
|
baseline and immediately after the intervention
|
|
Body Image State Scale
Time Frame: baseline and immediately after the intervention
|
Assesses changes in one's evaluative/affective body image states (6 items, 9-point scale), with higher scores indicating more favorable body image states.
|
baseline and immediately after the intervention
|
|
Positive and Negative Affect Schedule-Negative Affect
Time Frame: baseline and immediately after the intervention
|
Assesses changes in one's negative affect (20 items, 5-point scale), with higher scores indicating higher levels of negative affect.
|
baseline and immediately after the intervention
|
|
Internalized stigma among LGBTQ+ people scale
Time Frame: baseline and immediately after the intervention
|
Assesses changes in one's internalized LGBTQ+ stigma (5 items, 5-point scale), with higher scores indicating higher levels of internalized LGBTQ+ stigma.
|
baseline and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objectified Body Consciousness Scale- Surveillance scale
Time Frame: baseline
|
Assesses the extent to which one monitors one's physical appearance (8 items, 7-point scale), with higher scores indicating higher levels of body monitoring.
|
baseline
|
|
Eating Disorder Examination Questionnaire-10 item, 3 factor
Time Frame: baseline
|
Assesses the extent to which one endorses Dietary Restraint, Preoccupation and Eating Concern, and Shape/Weight Overvaluation (10 items, 7-point scale), with higher scores indicating higher levels of body monitoring.
|
baseline
|
|
Everyday Discrimination Scale
Time Frame: baseline
|
Assesses the frequency one experience day-to-day discrimination (9 items, 6-point scale), with higher scores indicating higher frequency of everyday discrimination.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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