๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-12-23

Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women (NCT05775497)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: The Miriam Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 โ‰ฅ2%) or the proportion of women achieving clinically meaningful weight loss (by โ‰ฅ10%) 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.

Who can join: Review the eligibility criteria below.

Location: Weight Control and Diabetes Research Center โ€” Providence, Rhode Island

Age range: 18 Years to 70 Years

๐Ÿงช Interventions in This Study

  • Behavioral weight loss intervention (Online; Rx Weight Loss) (BEHAVIORAL)
  • Minority stress intervention (BEHAVIORAL)
  • Social support intervention (BEHAVIORAL)
  • Negative body image intervention (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Weight Control and Diabetes Research Center โ€” Providence, Rhode Island

๐Ÿ“ž Contact the Study Coordinator

Phone: (401) 793-9714

Email: emily_panza@brown.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Obesity clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—