Clinical trial NCT06285968: The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities
Official title: Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Reducing Ethnic Disparities in Cardiometabolic Health (The DREAM Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-02-29
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in office systolic blood pressure
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in office systolic blood pressure (sustained effect at 24 weeks)
timeFrame: Baseline, 24 weeks
measure: Change in office diastolic blood pressure
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in out-of-office blood pressure
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in fasting glucose
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in body weight
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in waist circumference
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in diet quality
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Change in sleep health
timeFrame: Baseline, 8 weeks, and 24 weeks
measure: Acceptability of Implementation
timeFrame: 8 weeks and 24 weeks
measure: Feasibility of Implementation
timeFrame: 8 weeks and 24 weeks
measure: Appropriateness of Implementation
timeFrame: 8 weeks and 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center, Mailman School of Public Health
state: New York
Study officials:
affiliation: Columbia University
name: Nour Makarem, PhD
role: PRINCIPAL_INVESTIGATOR
References: