Sleep Health for Heart and Metabolic Health

Recruiting at 1 trial location

Overseen By Research Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

210 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{9 10 11 12 13}

Research Team

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Sleep2BWell Intervention Arm Experimental Treatment 3 Interventions

Sleep2BWell is a 6-week program, which consists of the 4-wk BWell4Life program enhanced with two sleep health education and group coaching sessions and addressing structural barriers to healthy sleep in NYC (light, noise, and indoor air pollution). The sleep health education sessions will incorporate didactic content, engaging animated videos, group coaching, and an interactive Q\&A period. These sessions will incorporate techniques to establish regular bed and wake times, learn wind-down and wake-up routines, cope with stress through muscle relaxation and mindfulness techniques, and optimize the sleep environment. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring. They will also receive a sleep mask, ear plugs, a blue light blocker, and an indoor air purifier to address barriers to healthy sleep in the sleep environment.

Group II: BWell4Life Control Arm Active Control 2 Interventions

BWell4Life is a 4-week community health promotion program focused on lifestyle change through consumption of a healthy diet and being physically active through weekly educational sessions, setting specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, and didactic content based on the American Heart Association (AHA) Life's Essential 8 framework. 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 and healthy proteins and reduce intakes of red and processed meats, sugary foods, and sugar-sweetened beverages. The two physical activity sessions provide an overview of the physical activity guidelines and include 30-60 minutes of exercise. These sessions also address achieving and maintaining a healthy body weight. Participants will receive a Fitbit for self-monitoring and collecting sleep health and physical activity data.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 36,480 Brazilian adults, those without sleep disturbances had significantly better cardiovascular health, as indicated by higher Life's Simple 7 (LS7) scores, compared to those experiencing sleep issues.

The severity of sleep disturbances was directly linked to lower cardiovascular health scores, with individuals reporting disturbances almost every day having the lowest scores, suggesting that improving sleep quality could be important for enhancing cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. Velasquez-Melendez, G., Andrade, FCD., Moreira, AD., et al.[2022]

In a study of 2,162 participants, significant associations were found between sleep structure (like total sleep time and sleep efficiency) and metabolic syndrome, hypertension, diabetes, and obesity, suggesting that sleep quality may influence these health conditions.

However, after adjusting for various factors such as age, sex, and sleep disorders, these associations diminished, indicating that normal variations in sleep may have little impact on metabolic syndrome and related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective sleep structure and cardiovascular risk factors in the general population: the HypnoLaus Study. Haba-Rubio, J., Marques-Vidal, P., Andries, D., et al.[2022]

A systematic review of 10 studies found that subjective sleep complaints, such as trouble falling asleep, are associated with an increased risk of coronary heart disease (CHD), with risk ratios ranging from 1.47 to 3.90 after adjusting for other factors.

The findings suggest that insomnia may be linked to heart problems through mechanisms like poor health, depression, stress, and reduced slow-wave sleep, indicating a need for further investigation into these connections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and heart disease: a review of epidemiologic studies. Schwartz, S., McDowell Anderson, W., Cole, SR., et al.[2022]

Sleep significantly influences cardiovascular function, affecting the autonomic nervous system and systemic hemodynamics, which can lead to serious events like cardiac arrhythmias and sudden death.

There is a causal link between sleep disorders (like sleep apnea and shift work) and cardiovascular diseases such as hypertension and heart failure, highlighting the need for better understanding and treatment strategies for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and cardiovascular disease. Wolk, R., Gami, AS., Garcia-Touchard, A., et al.[2022]

A multidimensional sleep health (MDSH) score, based on factors like sleep duration and regularity, was linked to significantly lower odds of cardiovascular disease (CVD) and type 2 diabetes among 4555 adults, indicating that better sleep health can improve cardiometabolic health.

Participants with ideal sleep health had 62% lower odds of hypertension and 73% lower odds of obesity compared to those with poor sleep health, highlighting the importance of comprehensive sleep assessments in understanding cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Sleep Health Is Associated with Cardiovascular Disease Prevalence and Cardiometabolic Health in US Adults. Makarem, N., Alcantara, C., Musick, S., et al.[2023]

Sleep impairment is not only a consequence of cardiovascular diseases but can also increase the risk of conditions like hypertension and stroke, highlighting the importance of monitoring heart rate abnormalities during sleep for early detection of cardiovascular issues.

Melatonin may play a crucial role in regulating cardiovascular function and sleep patterns, as disruptions in the circadian cycle and chronic sleep deficits are linked to increased sympathetic nervous system activity and a higher risk of obesity and cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and vascular disorders. Plante, GE.[2015]

A study of 277 Chinese participants identified 64 plasma metabolites linked to sleep timing, revealing that later sleep times are associated with higher levels of metabolites involved in amino acid and lipid metabolism.

The findings suggest that sleep timing, rather than sleep duration, may significantly impact cardiometabolic health by influencing various metabolic pathways, indicating potential areas for health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habitual Sleep and human plasma metabolomics. Xiao, Q., Derkach, A., Moore, SC., et al.[2022]

Epidemiological studies indicate that shorter sleep duration is linked to increased risks of metabolic disorders like obesity, diabetes, and hypertension, suggesting a mechanistic relationship between sleep and metabolism.

Sleep deprivation negatively affects hormones related to appetite and insulin sensitivity, which can lead to insulin resistance and hypertension, highlighting the importance of improving sleep quality and duration as potential preventive measures for these metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiological evidence for the links between sleep, circadian rhythms and metabolism. Gangwisch, JE.[2022]

In a study of 103 participants aged 25-64, a stable sleep pattern and higher daytime activity were linked to better cardiometabolic health, including lower weight, waist circumference, and blood pressure.

Higher night activity was associated with poorer sleep quality and increased levels of inflammatory markers like CRP, suggesting that maintaining a regular sleep-wake rhythm is crucial for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sleep-wake cycle regularity and cardiometabolic indicators]. Bochkarev, MV., Korostovtseva, LS., Tataraidze, AB., et al.[2021]

In a study of 121 participants aged 40-70 with multiple cardio-metabolic risk factors, those who underwent a health and lifestyle modification program showed a greater reduction in systolic blood pressure compared to the usual care group after 24 months.

Improvements in sleep quality, specifically increased sleep efficiency and total sleep time, were independently linked to lower blood pressure and improved cholesterol levels, suggesting that enhancing sleep could be an effective strategy for reducing cardio-metabolic risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial. Yiallourou, SR., Carrington, MJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Objective sleep structure and cardiovascular risk factors in the general population: the HypnoLaus Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Insomnia and heart disease: a review of epidemiologic studies. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep and cardiovascular disease. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Multidimensional Sleep Health Is Associated with Cardiovascular Disease Prevalence and Cardiometabolic Health in US Adults. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep and vascular disorders. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Habitual Sleep and human plasma metabolomics. [2022]

11. England pubmed.ncbi.nlm.nih.gov

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]

13. England pubmed.ncbi.nlm.nih.gov

Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial. [2021]