The DREAM Study: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health

Официальное название

Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health (The DREAM Study)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Multidimensional Sleep Health Promotion Intervention
  Multi-component multidimensional sleep health promotion intervention that includes goal setting, action planning, sleep health coaching and sleep hygiene education, a fixed sleep schedule, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.

Первичные конечные точки

• Change in office systolic blood pressure [Срок оценки: Baseline, 8 weeks]

Вторичные конечные точки (12)

• Change in office systolic blood pressure (sustained effect at 24 weeks) [Срок оценки: Baseline, 24 weeks]
• Change in office diastolic blood pressure [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in daytime blood pressure (during wake) [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in nighttime blood pressure (during sleep) [Срок оценки: Baseline, 8 weeks, 24 weeks]
• Change in mean 24-hour blood pressure [Срок оценки: Baseline, 8 weeks, 24 weeks]
• Change in fasting glucose [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in body weight [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in waist circumference [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in diet quality [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in multidimensional sleep health [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Changes in sleep duration [Срок оценки: Baseline, 8 weeks, 24 weeks]
• Changes in sleep regularity [Срок оценки: Baseline, 8 weeks, 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center, Mailman School of Public Health — New York

Идентификаторы

NCT: NCT06285968 · AAAU8937 · P50MD017341

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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