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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06285968
Status
Recruiting
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Conditions

  • Blood Pressure

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Multidimensional Sleep Health Promotion Intervention — 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.

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change in office systolic blood pressure [ Time Frame: Baseline, 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center, Mailman School of Public HealthNew YorkNew York10032
Nour Makarem, PhD
[email protected]

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By research site
Columbia University Irving Medical Center, Mailman School of Public Health· New York, NY

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