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NCT06565104 · ClinicalTrials.gov registry record · NA
The Sleep2BWell Trial
A NA study of Physical Activity and Weight Loss, sponsored by Columbia University.
- Active
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 2
- Study locations
NCT06565104 is a NA study of Physical Activity and Weight Loss that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 210 participants, below the 357-participant average among 131 other Physical Activity trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06565104, a NA study of Physical Activity and Weight Loss, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 2
- Study locations
Study Summary
Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 14 community sites will be randomized into the intervention (Sleep2BWell) or control (BWell4Life) group, enrolling an average of 15 participants per site for an expected sample of 210. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline, 10 weeks (primary endpoint), and 24 weeks (long-term follow-up to assess sustainability of the intervention's effect). The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity
Conditions Studied
Interventions
- BEHAVIORAL Multidimensional Sleep Health Sessions
- BEHAVIORAL Healthy Diet Sessions
- BEHAVIORAL Physical Activity Sessions
Study Locations (2)
New York
- Weill Cornell Medicine - New York
- Columbia University Irving Medical Center, Mailman School of Public Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2025-01-25 |
| Est. Completion | 2026-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06565104
The ClinicalTrials.gov registry entry for NCT06565104 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 357-participant average among 131 other Physical Activity trials with a reported enrollment target (41% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Physical Activity appearing as the primary indexed condition, and to 3 interventions - of which Multidimensional Sleep Health Sessions is the first listed.
NCT06565104 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06565104 about?
NCT06565104 is a clinical study titled "The Sleep2BWell Trial". Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health,...
What is the current status of trial NCT06565104?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2025-01-25. Estimated completion is 2026-03.
What conditions does trial NCT06565104 study?
This clinical trial studies the following conditions: Physical Activity, Weight Loss, Blood Pressure, Diet, Healthy, Sleep Health.
What interventions are being tested in trial NCT06565104?
The interventions under investigation include: Multidimensional Sleep Health Sessions (BEHAVIORAL), Healthy Diet Sessions (BEHAVIORAL), Physical Activity Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT06565104?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06565104 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.