Recruiting

Sleep2BWell

Sponsor:

Columbia University

Code:

NCT06565104

Conditions

Blood Pressure

Sleep Health

Diet, Healthy

Physical Activity

Weight Loss

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

Multidimensional Sleep Health Sessions

Healthy Diet Sessions

Physical Activity Sessions

Study Details

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.

Conditions

Blood Pressure

Sleep Health

Diet, Healthy

Physical Activity

Weight Loss

Study ID

NCT06565104

Start date

Jan 25, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sleep2BWell Intervention

Sleep2BWell is a 6-week program, which consists of the 4-wk BWell4Life program enhanced with two sleep health education and group coaching sessions and addressing structural barriers to healthy sleep in NYC (light, noise, and indoor air pollution). The sleep health education sessions will incorporate didactic content, engaging animated videos, group coaching, and an interactive Q\&A period. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring.

BWell4Life is a 4-week community health promotion program focused on lifestyle change through consumption of a healthy diet and being physically active through weekly educational sessions, setting S.M.A.R.T. goals for health behavior modification, and didactic content based on the American Heart Association (AHA) Life's Essential 8 framework, healthy cooking and exercise sessions.

Interventions

Multidimensional Sleep Health Sessions

The two sleep health educational sessions will include didactic content on defining sleep health, reviewing sleep recommendations, outlining the role of sleep in preserving cardiometabolic health, and correcting unhelpful sleep-related beliefs and debunking myths. Participants will learn to maximize the benefits of self-monitoring using a Fitbit and will receive a sleep mask, ear plugs, a blue light blocker, and an indoor air purifier to improve their sleep environment.

Healthy Diet Sessions

The two diet sessions include an overview of nutrition basics, examples of healthy dietary patterns and cooking methods to increase consumption of plant-based foods such as fruits, vegetables, and whole grains, promote choosing more lean proteins such as fish, and reduce intakes of red and processed meats, sugary foods, and sugar-sweetened beverages.

Physical Activity Sessions

The two physical activity sessions provide an overview of the physical activity guidelines and include 30-60 minutes of exercise and a healthy living community resource mapping exercise. These sessions also address achieving and maintaining a healthy body weight.

Primary outcome measure

  • Change in systolic blood pressure [ Time Frame: baseline to 10 weeks ]

Central Contacts and Locations

Central contacts

Research Project Coordinator

(646) 962-5011Sleep2BWell@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Erica Phillips, MD

erp2001@med.cornell.edu

Columbia University Irving Medical Center, Mailman School of Public Health

Recruiting

New York, New York, United States, 10032

Contacts

Nour Makarem, PhD

nm2968@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-14.