Adding Sleep to the BWell4Life Diet and Physical Activity Intervention for Cardiometabolic Health Promotion: The Sleep2BWell Community-Based Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English- and/or Spanish-speaking
- •aged ≥20 years
- •having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)
排除标准
- •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
研究组 & 干预措施
Sleep2BWell Intervention
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.
干预措施: Multidimensional Sleep Health Sessions (Behavioral)
Sleep2BWell Intervention
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.
干预措施: Healthy Diet Sessions (Behavioral)
Sleep2BWell Intervention
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.
干预措施: Physical Activity Sessions (Behavioral)
结局指标
主要结局
Change in systolic blood pressure
时间窗: 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.
次要结局
- Change in sleep quality(baseline, 10 weeks, 24 weeks)
- Change in alertness(baseline, 10 weeks, 24 weeks)
- Change in physical activity(baseline, 10 weeks, 24 weeks)
- Change in body weight(baseline, 10 weeks, 24 weeks)
- Change in systolic blood pressure (sustained effect at 24 weeks)(baseline, 24 weeks)
- Change in diastolic blood pressure(baseline, 10 weeks, 24 weeks)
- Change in sleep health(baseline, 10 weeks, 24 weeks)
- Change in diet quality(baseline, 10 weeks, 24 weeks)
- Change in percent body fat(baseline, 10 weeks, 24 weeks)
- Appropriateness of Implementation(10 weeks)
- Change in sleep duration(baseline, 10 weeks, 24 weeks)
- Feasibility of Implementation(10 weeks)
- Change in sleep efficiency(baseline, 10 weeks, 24 weeks)
- Change in waist circumference(baseline, 10 weeks, 24 weeks)
- Acceptability of Implementation(10 weeks)
- Change in sleep regularity(baseline, 10 weeks, 24 weeks)
- Change in sleep quality(baseline, 10 weeks)
- Change in alertness(baseline, 10 weeks)
- Change in diet quality(baseline, 10 weeks)
- Change in physical activity(baseline, 10 weeks)
- Change in body weight(baseline, 10 weeks)
- Change in waist circumference(baseline, 10 weeks)
- Change in percent body fat(baseline, 10 weeks)
- Satisfaction with Intervention(10 weeks)
- Change in diastolic blood pressure(baseline, 10 weeks)
- Change in sleep health(baseline, 10 weeks)
- Change in sleep duration(baseline, 10 weeks)
- Change in sleep efficiency(baseline, 10 weeks)
- Change in sleep regularity(baseline, 10 weeks)
研究者
Nour Makarem, PhD
Assistant Professor of Epidemiology
Columbia University