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Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
NCT05775497 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- BEHAVIORAL Behavioral weight loss intervention (Online; Rx Weight Loss)
- BEHAVIORAL Minority stress intervention
- BEHAVIORAL Social support intervention
- BEHAVIORAL Negative body image intervention
Study Locations (1)
Rhode Island
- Weight Control and Diabetes Research Center — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2025-12-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05775497
The ClinicalTrials.gov registry entry for NCT05775497 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Miriam Hospital, which has 139 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 4 interventions — of which Behavioral weight loss intervention (Online; Rx Weight Loss) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05775497 reports 1 study location spanning 1 distinct geographic area — top geographies include Rhode Island. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05775497 about?
NCT05775497 is a clinical study titled "Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women". 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 resear...
What is the current status of trial NCT05775497?
This trial is currently recruiting. It is a NA study. The enrollment target is 88 participants. The study started on 2024-05-01. Estimated completion is 2025-12-29.
What conditions does trial NCT05775497 study?
This clinical trial studies the following conditions: Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05775497?
The interventions under investigation include: Behavioral weight loss intervention (Online; Rx Weight Loss) (BEHAVIORAL), Minority stress intervention (BEHAVIORAL), Social support intervention (BEHAVIORAL), Negative body image intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05775497?
This trial is sponsored by The Miriam Hospital, which has 139 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05775497 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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