The Sleep2BWell Trial

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Change in systolic blood pressure [Time frame: baseline to 10 weeks]

Secondary outcome measures (12)

• Change in diastolic blood pressure [Time frame: baseline, 10 weeks]
• Change in sleep health [Time frame: baseline, 10 weeks]
• Change in sleep duration [Time frame: baseline, 10 weeks]
• Change in sleep efficiency [Time frame: baseline, 10 weeks]
• Change in sleep regularity [Time frame: baseline, 10 weeks]
• Change in sleep quality [Time frame: baseline, 10 weeks]
• Change in alertness [Time frame: baseline, 10 weeks]
• Change in diet quality [Time frame: baseline, 10 weeks]
• Change in physical activity [Time frame: baseline, 10 weeks]
• Change in body weight [Time frame: baseline, 10 weeks]
• Change in waist circumference [Time frame: baseline, 10 weeks]
• Change in percent body fat [Time frame: baseline, 10 weeks]

Eligibility criteria

Inclusion criteria

• English- and/or Spanish-speaking
• aged ≥20 years
• having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 2 centers

• Weill Cornell Medicine — New York
• Columbia University Irving Medical Center, Mailman School of Public Health — New York

Identifiers

NCT: NCT06565104 · AAAU9042 · 3P50MD017341-03S2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗