The Sleep2BWell Trial

Recruiting now · Not applicable

Conditions studied: Blood Pressure, Sleep Health, Diet, Healthy, Physical Activity, Weight Loss

In brief

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.

Key facts

Study ID

NCT06565104

Run by

Columbia University

People needed

150

Starts

2025-01-25

Expected to finish

2027-06-01

Last updated by the study team

2026-04-14

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• English- and/or Spanish-speaking
• aged ≥20 years
• having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)

You may not qualify if…

• 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)
• History of cardiovascular disease or cancer
• Pregnant or desire to become pregnant during the study
• Less than one year postpartum

Where it is running

• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center, Mailman School of Public Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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