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

The change office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across randomization arms.

The change office systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.

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.

Mean daytime blood pressure (mean of blood pressure readings during the wake period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office daytime blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.

Mean nighttime blood pressure (mean of blood pressure readings during the sleep period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.

Mean 24-h blood pressure (mean of the wake and sleep blood pressure values, weighted by the relative amounts of time spent awake and asleep) will be computed using valid readings from 24-h 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.

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.

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.

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.

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.

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.

Sleep duration will be assessed from wrist actigraphy. Optimal sleep duration will be defined as having an average sleep duration (hours/night) ≥ 7 hours and < 9 hours, given a score of 1 if met or 0 if not. Changes in sleep duration (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep regularity will be assessed from wrist actigraphy. Optimal sleep regularity will be defined as having a standard deviation of sleep duration and timing variables < 60 minutes, given a score of 1 if met or 0 if not. Changes in sleep duration SD and sleep timing SD (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep efficiency will be assessed from wrist actigraphy. Optimal sleep efficiency will be defined as having an average sleep efficiency (%) ≥ 85%, given a score of 1 if met or 0 if not. Changes in sleep efficiency (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep timing will be assessed from wrist actigraphy. Optimal sleep timing will be defined as having an earlier sleep period (sleep midpoint earlier than 4:00 AM), given a score of 1 if met or 0 if not. Changes in sleep timing (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep alertness will be assessed from the self reported Epworth Sleepiness Scale (ESS). Optimal sleep alertness will be defined as having normal daytime sleepiness (ESS ≤ 10). Scores range from 0-24, where a score ≥ 11 indicated excessive daytime sleepiness. Changes in the ESS score (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep satisfaction will be assessed from the consensus sleep diary. Sleep satisfaction is measured on a Likert scale (1 = very poor; 2 = poor; 3 = fair; 4 = good; 5 = very good). Change in sleep satisfaction from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which captures seven clinical components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction) over the past month. The PSQI score ranges from 0-21 with higher scores suggesting significant sleep difficulties. The change in PSQI scores from baseline to follow-up at 8 weeks and 24 weeks will be assessed and compared across randomization arms.

The Patient Health Questionnaire-8 (PHQ-8) measures depression symptom severity over the past two weeks, will be used to measure the severity of depression and screen for depressive disorders. The PHQ-8 scores range from 0-24 with higher scores indicating higher depression severity. The change in PHQ-8 scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.

The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity over the past two weeks, will be used to screen for generalized anxiety disorder and measure the severity of anxiety. The GAD-7 scores range from 0-21 with higher scores indicating higher levels of anxiety. The change in GAD-7 scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.

The Perceived Stress Scale (PSS-10), which helps identify if individuals feel their lives are overloaded, unpredictable, or uncontrollable will be used to measure subjective perception of stress. The PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. The change in PSS-10 scores from baseline to 8 weeks and 24 weeks will be calculated.

The ENRICHD Social Support Instrument (ESSI) measures perceived emotional and instrumental support. The ESSI scores range from 8 to 34 with higher scores indicating higher levels of support and low support is generally defined as total score ≤ 18 and a score of ≤ 3 on two or more items. The change in ESSI scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.

Participant will rate their health as excellent, very good, good, fair, or poor at baseline to 8 weeks and 24 weeks. Changes in self-rated health from baseline to 8 weeks and 24 weeks as well as the differences in mean self-rated health will be compared across the randomization arms.

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.

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.

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.

Net promoter score and questions about satisfaction with various intervention components.

Qualitative feedback on satisfaction, feasibility, acceptability, appropriateness, and scalability will be gathered from participants and staff