The Sleep2BWell Trial

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06565104
• Lead Sponsor: Columbia University

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 14 community sites will be randomized into the intervention (Sleep2BWell) or control (BWell4Life) group, enrolling an average of 15 participants per site for an expected sample of 210. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline, 10 weeks (primary endpoint), and 24 weeks (long-term follow-up to assess sustainability of the intervention's effect). The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes), as well as better glycemic control and inflammatory and allostatic load indicators (exploratory 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2025-01-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in sleep quality	baseline, 10 weeks, 24 weeks	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (score range: 0-21) at baseline, 10 weeks, and 24 weeks. Changes in sleep quality from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in alertness	baseline, 10 weeks, 24 weeks	Alertness will be captured by measuring excessive daytime sleepiness using the Epworth Sleepiness Scale (range: 0-24) at baseline, 10 weeks, and 24 weeks. Changes in daytime sleepiness from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in physical activity	baseline, 10 weeks, 24 weeks	The change in minutes/week spent in moderate-to-vigorous intensity and light intensity physical activity from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in body weight	baseline, 10 weeks, 24 weeks	The change in body weight (in lbs) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in systolic blood pressure (sustained effect at 24 weeks)	baseline, 24 weeks	The change in systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.
Change in diastolic blood pressure	baseline, 10 weeks, 24 weeks	The change diastolic blood pressure (mmHg) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in sleep health	baseline, 10 weeks, 24 weeks	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, 10 weeks, and 24 weeks. Changes in sleep health from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in diet quality	baseline, 10 weeks, 24 weeks	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 and 24 weeks will be calculated and compared across randomization arms.
Change in percent body fat	baseline, 10 weeks, 24 weeks	The change in % body fat from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Appropriateness of Implementation	10 weeks	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.
Change in sleep duration	baseline, 10 weeks, 24 weeks	Sleep duration (hours) will be assessed at baseline, 10 weeks, and 24 weeks. Changes in sleep duration from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Feasibility of Implementation	10 weeks	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.
Change in sleep efficiency	baseline, 10 weeks, 24 weeks	Sleep efficiency (%) will be assessed at baseline, 10 weeks, and 24 weeks. Changes in sleep efficiency from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Change in waist circumference	baseline, 10 weeks, 24 weeks	The change in waist circumference (inches) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.
Acceptability of Implementation	10 weeks	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.
Change in sleep regularity	baseline, 10 weeks, 24 weeks	Sleep regularity will be assessed from the standard deviation of sleep duration and timing at baseline, 10 weeks, and 24 weeks. Changes in sleep regularity from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.

Trial Locations

Locations (2)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center, Mailman School of Public Health; 🇺🇸 New York, New York, United States