Blood PressureNCT06565104
The Sleep2BWell Trial
A study testing Multidimensional Sleep Health Sessions, Healthy Diet Sessions and Physical Activity Sessions in people with Blood Pressure and Sleep Health, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Sleep Health, Diet, Healthy
- What is being tested?
- Multidimensional Sleep Health Sessions, Healthy Diet Sessions and Physical Activity Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English- and/or Spanish-speaking
- aged ≥20 years
- having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Erica Phillips, MD, erp2001@med.cornell.edu
- Recruiting
Columbia University Irving Medical Center, Mailman School of Public Health
New York, New York, 10032
Nour Makarem, PhD, nm2968@cumc.columbia.edu
About this study
Official title: Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based 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.
- Conditions
- Blood Pressure, Sleep Health, Diet, Healthy, Physical Activity, Weight Loss
- Being tested
- Multidimensional Sleep Health Sessions, Healthy Diet Sessions, Physical Activity Sessions
- Medical subject headings
- Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Sleep Health SessionsBehavioural
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.
Healthy Diet SessionsBehavioural
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.
Physical Activity SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep2BWell Intervention | Experimental | 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. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring.
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 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, healthy cooking and exercise sessions. Receives: Behavioral: Multidimensional Sleep Health Sessions; Behavioral: Healthy Diet Sessions; Behavioral: Physical Activity Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 10 weeks
Secondary outcomes (16)
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.
Measured: baseline, 10 weeks
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.
Measured: baseline, 10 weeks
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.
Measured: baseline, 10 weeks
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.
Measured: baseline, 10 weeks
Change in sleep regularity
Sleep regularity will be assessed from the standard deviation of sleep duration and timing at baseline and 10 weeks. Changes in sleep regularity from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (score range: 0-21) at baseline and 10 weeks. Changes in sleep quality from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in alertness
Alertness will be captured by measuring excessive daytime sleepiness using the Epworth Sleepiness Scale (range: 0-24) at baseline and 10 weeks. Changes in daytime sleepiness from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in diet quality
The change in the Mediterranean Eating Pattern for Americans (MEPA) score (range: 0-16 with higher scores indicating more favorable diet quality) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in physical activity
The change in minutes/week spent in moderate-to-vigorous intensity and light intensity physical activity from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in body weight
The change in body weight (in lbs) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in waist circumference
The change in waist circumference (inches) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Change in percent body fat
The change in % body fat from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
Measured: baseline, 10 weeks
Acceptability of Implementation
Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.
Measured: 10 weeks
Feasibility of Implementation
Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Measured: 10 weeks
Appropriateness of Implementation
Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
Measured: 10 weeks
Satisfaction with Intervention
Net promoter score (score range: 1-10) and Program Quality Rating on Likert Scale (Excellent, Very Good, Good, Fair, Poor)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start25 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Nour Makarem, PhD, Columbia University
- Investigators
- Nour Makarem, PhD, FAHA, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565104
- Sponsor's protocol ID
- AAAU9042
- Other IDs
- 3P50MD017341-03S2
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared consistent with guidance from NIMHD-funded HEAN coordinating center.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based Trial
- ClinicalTrials.gov ID
- NCT06565104
- Acronym / sponsor ID
- AAAU9042
- Conditions
- Blood Pressure, Sleep Health, Diet, Healthy, Physical Activity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep2BWell Intervention | Experimental | Behavioral: Multidimensional Sleep Health Sessions, Behavioral: Healthy Diet Sessions, Behavioral: Physical Activity SessionsSleep2BWell 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. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring. 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 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, healthy cooking and exercise sessions. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English- and/or Spanish-speaking
- aged ≥20 years
- having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional Sleep Health SessionsThe 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. | Behavioural | Sleep2BWell Intervention |
| Healthy Diet SessionsThe 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. | Behavioural | Sleep2BWell Intervention |
| Physical Activity SessionsThe 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. | Behavioural | Sleep2BWell Intervention |
Primary outcome
Change in systolic blood pressure
Time frame: baseline to 10 weeks
The change systolic blood pressure (mmHg) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.
16 secondary outcomes
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
Acceptability of Implementation
Time frame: 10 weeks
Feasibility of Implementation
Time frame: 10 weeks
Appropriateness of Implementation
Time frame: 10 weeks
Satisfaction with Intervention
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Data will be shared consistent with guidance from NIMHD-funded HEAN coordinating center.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nour Makarem, PhD, FAHA principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Sleep Health Sessions, Healthy Diet Sessions and Physical Activity Sessions in people with Blood Pressure and Sleep Health, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Project Coordinator ((646) 962-5011, Sleep2BWell@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.