Clinical trial NCT06565104: The Sleep2BWell Trial
Official title: Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based, Cluster-Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Sleep Health
Diet, Healthy
Physical Activity
Weight Loss
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-08-21
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: baseline to 10 weeks
Secondary outcomes:
measure: Change in systolic blood pressure (sustained effect at 24 weeks)
timeFrame: baseline, 24 weeks
measure: Change in diastolic blood pressure
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in sleep health
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in sleep duration
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in sleep efficiency
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in sleep regularity
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in sleep quality
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in alertness
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in diet quality
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in physical activity
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in body weight
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in waist circumference
timeFrame: baseline, 10 weeks, 24 weeks
measure: Change in percent body fat
timeFrame: baseline, 10 weeks, 24 weeks
measure: Acceptability of Implementation
timeFrame: 10 weeks
measure: Feasibility of Implementation
timeFrame: 10 weeks
measure: Appropriateness of Implementation
timeFrame: 10 weeks
Other outcomes:
measure: Change in fasting glucose
timeFrame: baseline, 24 weeks
measure: Change in allostatic load
timeFrame: baseline, 24 weeks
measure: Change in total cholesterol
timeFrame: baseline, 24 weeks
measure: The change in HDL cholesterol
timeFrame: baseline, 24 weeks
measure: The change in triglyceride levels
timeFrame: baseline, 24 weeks
measure: The change in C-Reactive Protein (CRP) levels
timeFrame: baseline, 24 weeks
measure: The change in Interleuken-6 (IL-6) levels
timeFrame: baseline, 24 weeks
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center, Mailman School of Public Health
state: New York
Study officials:
affiliation: Columbia University
name: Nour Makarem, PhD, FAHA
role: PRINCIPAL_INVESTIGATOR
References: