The Sleep2BWell Cluster-Randomized Trial
NCT Number: NCT06565104
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure|Sleep Health|Diet, Healthy|Physical Activity|Weight Loss
Interventions: BEHAVIORAL: Multidimensional Sleep Health Sessions|BEHAVIORAL: Healthy Diet Sessions|BEHAVIORAL: Physical Activity Sessions
Sponsor: Columbia University
Collaborators: Weill Medical College of Cornell University|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-03
Locations: Weill Cornell Medicine, New York, New York, 10021, United States|Columbia University Irving Medical Center, Mailman School of Public Health, New York, New York, 10032, United States

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. We 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). We 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, we 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. Our 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.

Primary Outcome Measures: 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: Change in systolic blood pressure (sustained effect at 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., baseline, 24 weeks|Change in diastolic blood pressure, 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., baseline, 10 weeks, 24 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, 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., baseline, 10 weeks, 24 weeks|Change in sleep duration, 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., baseline, 10 weeks, 24 weeks|Change in sleep efficiency, 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., baseline, 10 weeks, 24 weeks|Change in sleep regularity, 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., baseline, 10 weeks, 24 weeks|Change in sleep quality, 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., baseline, 10 weeks, 24 weeks|Change in alertness, 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., baseline, 10 weeks, 24 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 and 24 weeks will be calculated and compared across randomization arms., baseline, 10 weeks, 24 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 and 24 weeks will be calculated and compared across randomization arms., baseline, 10 weeks, 24 weeks|Change in body weight, 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., baseline, 10 weeks, 24 weeks|Change in waist circumference, 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., baseline, 10 weeks, 24 weeks|Change in percent body fat, The change in % body fat from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms., baseline, 10 weeks, 24 weeks|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
Other Outcome Measures: 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