The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities

Columbia University

Status: Active, not recruiting

Conditions: Blood Pressure

Treatments: Behavioral: Multidimensional Sleep Health Promotion Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06285968

P50MD017341 (U.S. NIH Grant/Contract)

AAAU8937

Details and patient eligibility

About

The purpose of this randomized controlled 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 Hispanic/Latina/o/x 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.

Full description

Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the disparate burden of multiple cardiometabolic morbidities in the Hispanic/Latina/o/x population. 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. Sleep health inequities have been shown to account for a large portion of racial and ethnic disparities in cardiometabolic risk. Therefore, culturally adapted sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.

Enrollment: 250 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 30-65 years
• Hispanic/Latina/o/x ethnicity
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Multidimensional Sleep Health Promotion Intervention

Experimental group

Description:

Participants randomized to the intervention arm will receive: 1. A multi-component multidimensional sleep health promotion intervention that includes virtual sleep health and sleep hygiene education, personalized feedback and establishment of a sleep health plan, behavioral coaching, self-monitoring, supportive accountability, and addressing light and noise in the sleep environment. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Treatment:

Behavioral: Multidimensional Sleep Health Promotion Intervention

Standard of care

No Intervention group

Description:

Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials.