NCT06565104

The Sleep2BWell Trial

Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-01-25
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-08-21
• Last updated: 2026-04-14

Locations

2 sites across 1 country: United States