| NCT ID | NCT06565104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-01-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 10 community sites will receive the intervention enrolling an average of 15 participants per site for an expected sample of 150. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline and 10 weeks (primary endpoint). The investigators hypothesize that Sleep2BWell will improve CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions.
Eligibility 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
Contact & Investigator
Nour Makarem, PhD, FAHA
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06565104 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565104 currently recruiting?
Yes, NCT06565104 is actively recruiting participants. Contact the research team at Sleep2BWell@med.cornell.edu for enrollment information.
Where is the NCT06565104 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT06565104 clinical trial?
NCT06565104 is sponsored by Columbia University. The principal investigator is Nour Makarem, PhD, FAHA at Columbia University. The trial plans to enroll 150 participants.