210 Participants Needed

Sleep Health for Heart and Metabolic Health

Recruiting at 1 trial location
RP
Overseen ByResearch Project Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is the Sleep2BWell treatment generally safe for humans?

The research articles do not provide specific safety data for the Sleep2BWell treatment, but they highlight the importance of good sleep for heart and metabolic health. Poor sleep is linked to higher risks of heart disease and other health issues, suggesting that improving sleep could be beneficial.12345

How does the Sleep2BWell treatment differ from other treatments for heart and metabolic health?

Sleep2BWell is unique because it focuses on improving sleep quality and efficiency as a way to reduce cardio-metabolic risk factors, such as high blood pressure and cholesterol levels, which is different from traditional treatments that may focus directly on medication or lifestyle changes without specifically targeting sleep.678910

What data supports the effectiveness of the treatment Sleep2BWell for heart and metabolic health?

Research shows that poor sleep quality and short sleep duration are linked to heart problems and metabolic issues like diabetes and obesity. Improving sleep could help reduce these risks, suggesting that treatments like Sleep2BWell might be beneficial for heart and metabolic health.35111213

Who Is on the Research Team?

NM

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

The Sleep2BWell trial is for individuals interested in improving their sleep, diet, physical activity, and reducing high blood pressure. Participants will be from underserved NYC neighborhoods and involved with faith-based organizations or community centers. They should be willing to engage in a 6-week program involving education sessions, self-monitoring with Fitbit devices, and addressing environmental factors affecting sleep.

Inclusion Criteria

I am 20 years old or older.
Having at minimum SBP in the elevated or hypertension category (SBP ≥120 mmHg)

Exclusion Criteria

I have a history of heart disease or cancer.
No known medical conditions that would prevent them from safely participating in the trial (e.g., neurological degenerative disease such as Parkinson's, severe psychiatric disorders, substance use disorder)
Pregnant or desire to become pregnant during the study
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

BWell4Life Program

Participants engage in a 4-week community health promotion program focused on lifestyle change through diet and physical activity.

4 weeks
Weekly educational sessions

Sleep2BWell Intervention

Participants receive an enhanced 6-week intervention including sleep health education, group coaching, and addressing environmental barriers to healthy sleep.

6 weeks
Two sleep health education and group coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 10 weeks and 24 weeks.

24 weeks
Assessments at 10 weeks and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep2BWell
Trial Overview This study tests if adding sleep health components to the BWell4Life program can better improve cardiometabolic health (CMH). It compares two groups: one follows the standard BWell4Life plan focusing on diet and exercise; the other adds sessions on sleep health plus tools like Fitbits to monitor progress.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep2BWell Intervention ArmExperimental Treatment3 Interventions
Group II: BWell4Life Control ArmActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Published Research Related to This Trial

Patients with various cardiovascular diseases often experience poor sleep quality and duration, which are linked to worse cardiovascular outcomes, indicating that sleep issues should be addressed in treatment plans.
There is a complex, bidirectional relationship between sleep and cardiovascular diseases, suggesting that improving sleep could be a valuable target for treatment, although current studies show mixed results regarding survival benefits from sleep interventions.
Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing.Spiesshoefer, J., Linz, D., Skobel, E., et al.[2023]
In a study of 155,203 participants, it was found that only 69.5% reported getting at least 7 hours of sleep, and a significant 73.9% reported poor sleep quality, highlighting a widespread issue with sleep among different ethnic groups.
Filipinos and Other Asians were less likely to achieve adequate sleep compared to Whites and Chinese, while all Asian groups reported better sleep quality than Whites, indicating notable disparities in sleep patterns across these populations.
The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study.Inam, M., Kianoush, S., Sheikh, S., et al.[2023]
In a study of 21,193 individuals with coronary heart disease followed for an average of 11.1 years, maintaining a healthy sleep pattern was linked to a 12-22% lower risk of heart failure and recurrent cardiovascular events.
Participants with a higher healthy sleep score (4) had a significantly reduced risk of recurrent cardiovascular events (HR 0.86), heart failure (HR 0.71), and stroke (HR 0.72), suggesting that good sleep habits can help prevent further cardiovascular issues.
Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease.Liu, S., Wang, Y., Lu, Q., et al.[2023]

Citations

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. [2023]
The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study. [2023]
Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease. [2023]
Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. [2022]
Objective sleep structure and cardiovascular risk factors in the general population: the HypnoLaus Study. [2022]
Insomnia and heart disease: a review of epidemiologic studies. [2022]
Sleep and cardiovascular disease. [2022]
Multidimensional Sleep Health Is Associated with Cardiovascular Disease Prevalence and Cardiometabolic Health in US Adults. [2023]
Sleep and vascular disorders. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Habitual Sleep and human plasma metabolomics. [2022]
Epidemiological evidence for the links between sleep, circadian rhythms and metabolism. [2022]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Sleep-wake cycle regularity and cardiometabolic indicators]. [2021]
Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial. [2021]
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