Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT06565104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sleep2BWell Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in fasting glucose', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in fasting glucose (mg/dl) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in allostatic load', 'timeFrame': 'baseline, 24 weeks', 'description': 'Allostatic load will be measured by cardiovascular system, metabolic system, and inflammatory/immune system markers. Allostatic load will be computed such as that a score of 1 is assigned when a biomarker falls at or above a defined threshold (high risk) and a score of 0 is assigned when a biomarker falls below a defined threshold (low risk). High-risk thresholds are based on the following clinically defined cut points: 1) systolic blood pressure ≥140 mmHG, 2) diastolic blood pressure ≥90 mmHG, 3) total cholesterol ≥240 mg/dL, 4) HDL cholesterol \\<50 mg/dL, 5) triglycerides ≥150 mg/dL, 6) BMI \\>30.0 kg/m2, 7) waist-to-hip ratio \\>0.85, 8) HbA1c ≥5.5%, 9) CRP \\>3.0 μg/dL, and 10) IL-6 \\>6.5 pg/mL. The total score will range from 0 to 10 with greater values indicating higher allostatic load. The change in allostatic load from baseline to 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in total cholesterol', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in total cholesterol (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.'}, {'measure': 'The change in HDL cholesterol', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in HDL cholesterol (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.'}, {'measure': 'The change in triglyceride levels', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in triglyceride levels (mg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.'}, {'measure': 'The change in C-Reactive Protein (CRP) levels', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in CRP levels (μg/dL) from baseline to 24 weeks will be calculated and compared across the randomization arms.'}, {'measure': 'The change in Interleuken-6 (IL-6) levels', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in CRP levels (pg/mL) from baseline to 24 weeks will be calculated and compared across the randomization arms.'}], 'primaryOutcomes': [{'measure': 'Change in systolic blood pressure', 'timeFrame': 'baseline to 10 weeks', 'description': 'The change systolic blood pressure (mmHg) from baseline to follow-up at 10 weeks will be calculated and compared across randomization arms.'}], 'secondaryOutcomes': [{'measure': 'Change in systolic blood pressure (sustained effect at 24 weeks)', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change in systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'The change diastolic blood pressure (mmHg) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in sleep health', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': '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, 10 weeks, and 24 weeks. Changes in sleep health from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in sleep duration', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'Sleep duration (hours) will be assessed at baseline, 10 weeks, and 24 weeks. Changes in sleep duration from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in sleep efficiency', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'Sleep efficiency (%) will be assessed at baseline, 10 weeks, and 24 weeks. Changes in sleep efficiency from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in sleep regularity', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'Sleep regularity will be assessed from the standard deviation of sleep duration and timing at baseline, 10 weeks, and 24 weeks. Changes in sleep regularity from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in sleep quality', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (score range: 0-21) at baseline, 10 weeks, and 24 weeks. Changes in sleep quality from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in alertness', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'Alertness will be captured by measuring excessive daytime sleepiness using the Epworth Sleepiness Scale (range: 0-24) at baseline, 10 weeks, and 24 weeks. Changes in daytime sleepiness from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in diet quality', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': '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 and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in physical activity', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'The change in minutes/week spent in moderate-to-vigorous intensity and light intensity physical activity from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in body weight', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'The change in body weight (in lbs) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'The change in waist circumference (inches) from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Change in percent body fat', 'timeFrame': 'baseline, 10 weeks, 24 weeks', 'description': 'The change in % body fat from baseline to follow-up at 10 weeks and 24 weeks will be calculated and compared across randomization arms.'}, {'measure': 'Acceptability of Implementation', 'timeFrame': '10 weeks', 'description': '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.'}, {'measure': 'Feasibility of Implementation', 'timeFrame': '10 weeks', 'description': '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.'}, {'measure': 'Appropriateness of Implementation', 'timeFrame': '10 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure', 'Sleep Health', 'Diet, Healthy', 'Physical Activity', 'Weight Loss']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English- and/or Spanish-speaking\n2. aged ≥20 years\n3. having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)\n\nExclusion Criteria:\n\n1. 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)\n2. History of cardiovascular disease or cancer\n3. Pregnant or desire to become pregnant during the study\n4. Less than one year postpartum'}, 'identificationModule': {'nctId': 'NCT06565104', 'briefTitle': 'The Sleep2BWell Trial', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based, Cluster-Randomized Trial', 'orgStudyIdInfo': {'id': 'AAAU9042'}, 'secondaryIdInfos': [{'id': '3P50MD017341-03S2', 'link': 'https://reporter.nih.gov/quickSearch/3P50MD017341-03S2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BWell4Life Control Arm', 'description': "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.", 'interventionNames': ['Behavioral: Healthy Diet Sessions', 'Behavioral: Physical Activity Sessions']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep2BWell Intervention Arm', 'description': '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.', 'interventionNames': ['Behavioral: Multidimensional Sleep Health Sessions', 'Behavioral: Healthy Diet Sessions', 'Behavioral: Physical Activity Sessions']}], 'interventions': [{'name': 'Multidimensional Sleep Health Sessions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Sleep2BWell Intervention Arm']}, {'name': 'Healthy Diet Sessions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['BWell4Life Control Arm', 'Sleep2BWell Intervention Arm']}, {'name': 'Physical Activity Sessions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['BWell4Life Control Arm', 'Sleep2BWell Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center, Mailman School of Public Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nour Makarem, PhD, FAHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared consistent with guidance from NIMHD-funded HEAN coordinating center.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Epidemiology', 'investigatorFullName': 'Nour Makarem, PhD', 'investigatorAffiliation': 'Columbia University'}}}}