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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
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.
Columbia University Irving Medical Center, Mailman School of Public Health
New York, New York, United States
RECRUITINGChange 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.
Time frame: Baseline, 8 weeks
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.
Time frame: Baseline, 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: Baseline, 8 weeks, and 24 weeks
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.
Time frame: 8 weeks and 24 weeks
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.
Time frame: 8 weeks and 24 weeks
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.
Time frame: 8 weeks and 24 weeks
Satisfaction with intervention
Net promoter score and questions about satisfaction with various intervention components.
Time frame: 8 weeks and 24 weeks
Qualitative feedback from interviews on intervention feasibility and implementation
Qualitative feedback on satisfaction, feasibility, acceptability, appropriateness, and scalability will be gathered from participants and staff
Time frame: 8 weeks and 24 weeks
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