The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Blood Pressure

Clinical Trial Details

NCT number	NCT06285968
Study type	Interventional
Source	Columbia University
Contact	Research Project Coordinator
Phone	212-305-3317
Email	dream@cumc.columbia.edu
Status	Recruiting
Phase	N/A
Start date	March 12, 2024
Completion date	March 31, 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms