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NCT05775497 · ClinicalTrials.gov registry record · NA
Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
A NA study of Obesity, sponsored by The Miriam Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT05775497 is a NA study of Obesity that is actively recruiting participants, run by The Miriam Hospital. The registered enrollment target is 88 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05775497, a NA study of Obesity, is actively recruiting participants, sponsored by The Miriam Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The listed sponsor is The Miriam Hospital, which has 136 total studies on file at ClinicalTrials.gov.
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.
NCT05775497 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
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.
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).
Who is sponsoring clinical trial NCT05775497?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
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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Related
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