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The Sleep2BWell Trial

Columbia University · with Weill Medical College of Cornell University, National Institute on Minority Health and Health Disparities (NIMHD) · NCT06565104

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 20+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
2
Study start
January 25, 2025
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Multidimensional Sleep Health Sessions; Healthy Diet Sessions; Physical Activity Sessions

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Recruiting US locations

  • Weill Cornell Medicine

    New York, NY 10021

    Site contact: Erica Phillips, MD · erp2001@med.cornell.edu

  • Columbia University Irving Medical Center, Mailman School of Public Health

    New York, NY 10032

    Site contact: Nour Makarem, PhD · nm2968@cumc.columbia.edu

Study contacts (from the official record)

  • Research Project Coordinator · (646) 962-5011 · Sleep2BWell@med.cornell.edu
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The Sleep2BWell Trial (NCT06565104) | Bored Studies