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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: Recruiting NA study of Obesity, sponsored by The Miriam Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
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 |
What NCT05775497 shows while recruiting
NCT05775497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05775497's enrollment target sits among peer trials
88 530th of 1053 higher than 522 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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