The Sleep2BWell Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Weight Loss; Blood Pressure; Diet, Healthy; Sleep Health
• Intervention / Treatment: Behavioral: Healthy Diet Sessions; Behavioral: Physical Activity Sessions; Behavioral: Multidimensional Sleep Health Sessions

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Project Coordinator; Phone Number: (646) 962-5011; Email: Sleep2BWell@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Erica Phillips, MD; Email: erp2001@med.cornell.edu
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center, Mailman School of Public Health
      • Contact: Nour Makarem, PhD; Email: nm2968@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Implementation	Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.	10 weeks
Feasibility of Implementation	Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.	10 weeks
Appropriateness of Implementation	Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.	10 weeks
Change in diastolic blood pressure	The change diastolic blood pressure (mmHg) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in sleep health	Sleep health will be assessed using sleep duration, regularity, efficiency, and timing from the Fitbit and self-reported sleep satisfaction and alertness (measured by daytime sleepiness). Optimal sleep health will be defined as having an average sleep duration (hours/night) ≥7 hours and <9 hours, regular sleep duration and timing (standard deviation of sleep duration and timing variables <90 minutes), sleep efficiency (%) ≥85%, an earlier sleep period (sleep midpoint earlier than 4:00 AM), normal daytime sleepiness (Epworth Sleepiness Scale ≤10), and good self-rated sleep satisfaction and quality. Sleep health will be assessed at baseline and 10 weeks. Changes in sleep health from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in sleep duration	Sleep duration (hours) will be assessed at baseline and 10 weeks. Changes in sleep duration from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in sleep efficiency	Sleep efficiency (%) will be assessed at baseline and 10 weeks. Changes in sleep efficiency from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in sleep regularity	Sleep regularity will be assessed from the standard deviation of sleep duration and timing at baseline and 10 weeks. Changes in sleep regularity from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in sleep quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (score range: 0-21) at baseline and 10 weeks. Changes in sleep quality from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in alertness	Alertness will be captured by measuring excessive daytime sleepiness using the Epworth Sleepiness Scale (range: 0-24) at baseline and 10 weeks. Changes in daytime sleepiness from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in diet quality	The change in the Mediterranean Eating Pattern for Americans (MEPA) score (range: 0-16 with higher scores indicating more favorable diet quality) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in physical activity	The change in minutes/week spent in moderate-to-vigorous intensity and light intensity physical activity from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in body weight	The change in body weight (in lbs) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in waist circumference	The change in waist circumference (inches) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Change in percent body fat	The change in % body fat from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.	baseline, 10 weeks
Satisfaction with Intervention	Net promoter score (score range: 1-10) and Program Quality Rating on Likert Scale (Excellent, Very Good, Good, Fair, Poor)	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose	The change in fasting glucose (mg/dl) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.	baseline, 24 weeks
Change in allostatic load	Allostatic load will be measured by cardiovascular system, metabolic system, and inflammatory/immune system markers. Allostatic load will be computed such as that a score of 1 is assigned when a biomarker falls at or above a defined threshold (high risk) and a score of 0 is assigned when a biomarker falls below a defined threshold (low risk). High-risk thresholds are based on the following clinically defined cut points: 1) systolic blood pressure ≥140 mmHG, 2) diastolic blood pressure ≥90 mmHG, 3) total cholesterol ≥240 mg/dL, 4) HDL cholesterol <50 mg/dL, 5) triglycerides ≥150 mg/dL, 6) BMI >30.0 kg/m2, 7) waist-to-hip ratio >0.85, 8) HbA1c ≥5.5%, 9) CRP >3.0 μg/dL, and 10) IL-6 >6.5 pg/mL. The total score will range from 0 to 10 with greater values indicating higher allostatic load. The change in allostatic load from baseline to 24 weeks will be calculated and compared across randomization arms.	baseline, 24 weeks
Change in total cholesterol	The change in total cholesterol (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.	baseline, 24 weeks
The change in HDL cholesterol	The change in HDL cholesterol (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.	baseline, 24 weeks
The change in triglyceride levels	The change in triglyceride levels (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.	baseline, 24 weeks
The change in C-Reactive Protein (CRP) levels	The change in CRP levels (μg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.	baseline, 24 weeks
The change in Interleuken-6 (IL-6) levels	The change in CRP levels (pg/mL) from baseline to 24 weeks will be calculated and compared across the randomization arms.	baseline, 24 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Weill Medical College of Cornell University
• Investigators: Principal Investigator: Nour Makarem, PhD, FAHA, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Weight Loss; Motor Activity
• Other Study ID Numbers: AAAU9042; 3P50MD017341-03S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared consistent with guidance from NIMHD-funded HEAN coordinating center.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No