Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health (The DREAM Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in office systolic blood pressure
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.
详细描述
Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the burden of multiple cardiometabolic morbidities. Despite a strong evidence base supporting the role of sleep as a major contributor to cardiometabolic health preservation, most lifestyle interventions have targeted diet or physical activity and not sleep. Sleep is amenable to intervention and can improve cardiometabolic health through complementary or synergistic biologic pathways with other lifestyle factors. Therefore, pragmatic multidimensional sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 30+ years
- •English or Spanish speaking
- •Systolic blood pressure greater than or equal to 120 mmHg
- •Sub-optimal sleep health
- •No history of overt cardiovascular disease
- •No history of cancer
排除标准
- •Optimal sleep health
- •History of cardiovascular disease or cancer
- •Non-English or non-Spanish speaking
- •Not cognitively able to complete study requirements
- •Severe psychiatric disorders
- •Inability to provide informed consent
研究组 & 干预措施
Multidimensional Sleep Health Promotion Intervention
Participants randomized to the intervention arm will receive:
- A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.
- Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.
干预措施: Multidimensional Sleep Health Promotion Intervention (Behavioral)
Standard of care
Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials, providing guidance on healthy sleep duration only.
结局指标
主要结局
Change in office systolic blood pressure
时间窗: Baseline, 8 weeks
The change office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across randomization arms.
次要结局
- Change in out-of-office blood pressure(Baseline, 8 weeks, and 24 weeks)
- Change in fasting glucose(Baseline, 8 weeks, and 24 weeks)
- Change in body weight(Baseline, 8 weeks, and 24 weeks)
- Change in waist circumference(Baseline, 8 weeks, and 24 weeks)
- Change in diet quality(Baseline, 8 weeks, and 24 weeks)
- Change in sleep health(Baseline, 8 weeks, and 24 weeks)
- Acceptability of Implementation(8 weeks and 24 weeks)
- Feasibility of Implementation(8 weeks and 24 weeks)
- Appropriateness of Implementation(8 weeks and 24 weeks)
- Change in office systolic blood pressure (sustained effect at 24 weeks)(Baseline, 24 weeks)
- Change in office diastolic blood pressure(Baseline, 8 weeks, and 24 weeks)
- Change in office systolic blood pressure (sustained effect at 24 weeks)(Baseline, 24 weeks)
- Change in office diastolic blood pressure(Baseline, 8 weeks, and 24 weeks)
- Change in out-of-office blood pressure(Baseline, 8 weeks, and 24 weeks)
- Change in fasting glucose(Baseline, 8 weeks, and 24 weeks)
- Change in body weight(Baseline, 8 weeks, and 24 weeks)
- Change in sleep health(Baseline, 8 weeks, and 24 weeks)
- Change in waist circumference(Baseline, 8 weeks, and 24 weeks)
- Acceptability of Implementation(8 weeks and 24 weeks)
- Feasibility of Implementation(8 weeks and 24 weeks)
- Appropriateness of Implementation(8 weeks and 24 weeks)
- Change in diet quality(Baseline, 8 weeks, and 24 weeks)
- Satisfaction with intervention(8 weeks and 24 weeks)
- Qualitative feedback from interviews on intervention feasibility and implementation(8 weeks and 24 weeks)
研究者
Nour Makarem, PhD
Assistant Professor of Epidemiology
Columbia University