The Sleep2BWell Trial

NCT06565104 | Recruiting

• 2 other identifiers: AAAU90423P50MD017341-03S2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

  The change systolic blood pressure (mmHg) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.

  baseline to 10 weeks

Secondary Outcomes (16)

• Change in diastolic blood pressure

  baseline, 10 weeks

• Change in sleep health

  baseline, 10 weeks

• Change in sleep duration

  baseline, 10 weeks

• Change in sleep efficiency

  baseline, 10 weeks

• Change in sleep regularity

  baseline, 10 weeks

Study Arms (1)

Sleep2BWell Intervention

EXPERIMENTAL

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.

Behavioral: Multidimensional Sleep Health Sessions; Behavioral: Healthy Diet Sessions; Behavioral: Physical Activity Sessions

Interventions

Multidimensional Sleep Health Sessions BEHAVIORAL

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.

Sleep2BWell Intervention

Healthy Diet Sessions BEHAVIORAL

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.

Sleep2BWell Intervention

Physical Activity Sessions BEHAVIORAL

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.

Sleep2BWell Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Columbia University: lead
• Weill Medical College of Cornell University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Columbia University Irving Medical Center, Mailman School of Public Health

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nour Makarem, PhD, FAHA

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Project Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: January 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)