Sleep2BWell: adding sleep health to diet and activity for better blood pressure
Official title: Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based Trial
Run by Columbia University · NCT06565104 · Data updated 2026-11-12
This program will try adding a sleep-health module to a community diet-and-exercise program to see if it helps adults with elevated blood pressure in underserved New York City neighborhoods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Status | Recruiting |
| Started | January 25, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT06565104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 or older who speak English or Spanish, have systolic blood pressure ≥120 mmHg, live in or can attend participating NYC community sites, and do not have major medical conditions that preclude participation are ideal candidates.
✕Probably not a fit
People with a history of cardiovascular disease or cancer, severe psychiatric or substance use disorders, those who are pregnant or planning pregnancy, or less than one year postpartum are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Sleep2BWell is a community-based cluster randomized trial that adds multidimensional sleep health content to the existing BWell4Life healthy diet and physical activity program, extending the intervention from 4 to 6 weeks. Peer health educators deliver the program at faith-based organizations and community centers in underserved NYC neighborhoods. Adult participants aged 20 or older with systolic blood pressure ≥120 mmHg are enrolled, and sites are randomized to deliver either the enhanced sleep-plus program or the standard program. Outcomes focus on cardiometabolic health measures and feasibility of integrating sleep interventions into real-world community settings.
Why it matters
Potential benefit: If successful, adding sleep health could lower blood pressure and improve overall cardiometabolic health for participants beyond diet and exercise alone.
How similar studies have gone: Prior clinical research suggests improving sleep can benefit cardiometabolic health, but few cluster-randomized community programs have tested integrating sleep with diet and physical activity, so this approach is only partially tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. English- and/or Spanish-speaking 2. aged ≥20 years 3. having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg) Exclusion Criteria: 1. No known medical conditions that would prevent them from safely participating in the trial (e.g., neurological degenerative disease such as Parkinsons, severe psychiatric disorders, substance use disorder) 2. History of cardiovascular disease or cancer 3. Pregnant or desire to become pregnant during the study 4. Less than one year postpartum
Where it's running
-
Weill Cornell Medicine
New York, New York, United States Recruiting -
Columbia University Irving Medical Center, Mailman School of Public Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Nour Makarem, PhD, FAHA — Columbia University
- Study coordinator: Research Project Coordinator
- Email: Sleep2BWell@med.cornell.edu
- Phone: (646) 962-5011
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.