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

Blood Pressure Clinical Trial

Official title:

Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Reducing Ethnic Disparities in Cardiometabolic Health (The DREAM Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285968
• Other study ID #: AAAU8937
• Secondary ID: P50MD017341
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Research Project Coordinator
• Phone: 212-305-3317
• Email: dream[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Multidimensional Sleep Health Promotion Intervention
Multi-component multidimensional sleep health promotion intervention that includes sleep health and sleep hygiene education, behavioral coaching, personalized feedback, goal setting and establishment of a sleep health plan, self-monitoring, supportive accountability, and addressing light and noise in the sleep environment.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center, Mailman School of Public Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in office systolic blood pressure	The change office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks
Secondary	Change in office systolic blood pressure (sustained effect at 24 weeks)	The change office systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.	Baseline, 24 weeks
Secondary	Change in office diastolic blood pressure	The change office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in out-of-office blood pressure	Mean daytime blood pressure (mean of blood pressure readings during the awake period), nighttime blood pressure (mean of blood pressure readings during the asleep period) and mean 24-h blood pressure (mean of the awake and asleep blood pressure values, weighted by the relative amounts of time spent awake and asleep) will be computed using valid readings from ambulatory blood pressure monitoring. Changes in these out-of-office blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in fasting glucose	The change in fasting glucose (mg/dl) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in body weight	The change in body weight (lbs) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in waist circumference	The change in waist circumference (inches) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in diet quality	The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Change in sleep health	Sleep health will be assessed using sleep duration, regularity, efficiency, and timing from wrist actigraphy and self-reported sleep satisfaction and alertness (measured by daytime sleepiness). Optimal sleep health will be defined as having an average sleep duration (hours/night) =7 hours and <9 hours, regular sleep duration and timing (standard deviation of sleep duration and timing variables <90 minutes), sleep efficiency (%) =85%, an earlier sleep period (sleep midpoint earlier than 4:00 AM), normal daytime sleepiness (Epworth Sleepiness Scale =10), and good self-rated sleep satisfaction and quality. Sleep health will be assessed at baseline, 8 weeks, and 24 weeks. Changes in sleep health from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.	Baseline, 8 weeks, and 24 weeks
Secondary	Acceptability of Implementation	Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.	8 weeks and 24 weeks
Secondary	Feasibility of Implementation	Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.	8 weeks and 24 weeks
Secondary	Appropriateness of Implementation	Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.	8 weeks and 24 weeks