Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women: MOST Optimization Phase

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program. In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to: Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months. Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns). This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Assigned female at birth and currently identify as female

• Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)

• BMI=25-50kg/m2

• 18-70 years old

• Interested in losing weight

• Regular internet and e-mail access

• No significant weight loss within past 6 months (\>5%)

• Fluent in English

• Able to participate in moderate physical activity

• Not currently enrolled in a weight loss program

• Not currently taking weight-loss medication

• Not 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)).

Locations
United States
Rhode Island
Weight Control and Diabetes Research Center
RECRUITING
Providence
Contact Information
Primary
Emily Panza, PhD
emily_panza@brown.edu
401-793-9714
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-12-29
Participants
Target number of participants: 88
Treatments
Experimental: Weight Loss Program Only
Participants complete an online behavioral weight loss program.
Experimental: Weight Loss Program + Coping with Stress Program
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.
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program
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.
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program
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.
Experimental: Weight Loss Program + Body Image Program + Social Support Program
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.
Experimental: Weight Loss Program + Coping with Stress Program + Social Support Program
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.
Experimental: Weight Loss Program + Body Image Program
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.
Experimental: Weight Loss Program + Social Support Program
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: The Miriam Hospital

This content was sourced from clinicaltrials.gov