The Sleep2BWell Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorColumbia University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English- and/or Spanish-speaking
aged ≥20 years
having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Multidimensional Sleep Health Sessions
BehavioralThe 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.
Healthy Diet Sessions
BehavioralThe 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.
Physical Activity Sessions
BehavioralThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Sleep2BWell InterventionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline to 10 weeksSecondary outcomes
1
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.
Time frame
baseline, 10 weeks2
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.
Time frame
baseline, 10 weeks3
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.
Time frame
baseline, 10 weeks4
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.
Time frame
baseline, 10 weeksSponsors and contacts
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Columbia University
Lead sponsor
Weill Medical College of Cornell University
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov