Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT05036187
• Lead Sponsor: The Miriam Hospital

Brief Summary

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Assigned female at birth and currently identify as female
• Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
• BMI>25kg/m2
• 18-70 years old
• Interested in losing weight
• Regular internet and e-mail access
• Fluent in English

Exclusion Criteria

• Significant weight loss within past 6 months (>5%)
• Unable to participate in moderate physical activity
• Currently enrolled in a weight loss program
• Currently taking weight-loss medication
• Currently pregnant or trying to get pregnant
• Participated in a previous Phase of this study
• Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability	Week 12 (post-treatment)	A measure of intervention acceptability adapted from the Acceptability of Intervention (AIM) measure will assess acceptability outcomes post-treatment. Qualitative data on intervention acceptability and cultural appropriateness will also be considered.

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center, The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States