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

NCT ID: NCT06285968

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2027-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multidimensional Sleep Health Promotion Intervention

Participants randomized to the intervention arm will receive:

1. 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.

2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Group Type: EXPERIMENTAL

Multidimensional Sleep Health Promotion Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults aged 30-65 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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nour Makarem, PhD

Assistant Professor of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nour Makarem, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center, Mailman School of Public Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Project Coordinator

Role: CONTACT

dream@cumc.columbia.edu

212-305-3317

Nour Makarem, PhD

Role: CONTACT

nm2968@cumc.columbia.edu

Facility Contacts

Nour Makarem, PhD

Role: primary

nm2968@cumc.columbia.edu

Other Identifiers

P50MD017341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU8937

Identifier Type: -

Identifier Source: org_study_id