Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Behavioral: Behavioral Weight Loss InterventionBehavioral: Minority Stress InterventionBehavioral: Negative Body Image InterventionBehavioral: Social Support Intervention
- 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
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
- Arm && Interventions
Group Intervention Description Weight Loss Program + Coping with Stress Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Social Support Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program Minority Stress Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Minority Stress Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program + Social Support Program Minority Stress Intervention Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Weight Loss Program + Coping with Stress Program + Body Image Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program + Body Image Program Minority Stress Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program + Body Image Program Negative Body Image Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program Only Behavioral Weight Loss Intervention Participants complete an online behavioral weight loss program. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Negative Body Image Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Body Image Program + Social Support Program Social Support Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Body Image Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Body Image Program + Social Support Program Negative Body Image Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Body Image Program + Social Support Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Body Image Program Negative Body Image Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Weight Loss Program + Coping with Stress Program + Social Support Program Behavioral Weight Loss Intervention Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Weight Loss Program + Social Support Program Social Support Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Weight Loss Program + Coping with Stress Program + Social Support Program Social Support Intervention Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Weight Loss Program + Social Support Program Behavioral Weight Loss Intervention Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Weight Control and Diabetes Research Center, The Miriam Hospital
🇺🇸Providence, Rhode Island, United States