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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017341 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidimensional Sleep Health Promotion Intervention | Experimental | Participants randomized to the intervention arm will receive:
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| Standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in office diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Project Coordinator | Contact | 212-305-3317 | dream@cumc.columbia.edu | |
| Nour Makarem, PhD | Contact | nm2968@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nour Makarem, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center, Mailman School of Public Health | Recruiting | New York | New York | 10032 | United States |
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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 |
| Change in daytime blood pressure (during wake) | 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. | Baseline, 8 weeks, and 24 weeks |
| Change in nighttime blood pressure (during sleep) | 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. | Baseline, 8 weeks, 24 weeks |
| Change in mean 24-hour blood pressure | 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. | Baseline, 8 weeks, 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. | 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. | 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. | 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. | Baseline, 8 weeks, and 24 weeks |
| Change in multidimensional 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 |
| Changes in sleep duration | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in sleep regularity | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in sleep efficiency | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in sleep timing | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in sleep alertness | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in sleep satisfaction | 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. | Baseline, 8 weeks, 24 weeks |
| Changes in subjective sleep quality | 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. | Baseline, 8 weeks, 24 weeks |
| Change in depression severity | 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. | Baseline, 8 weeks, 24 weeks |
| Change in anxiety severity | 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. | Baseline, 8 weeks, 24 weeks |
| Change in perceived stress | 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. | Baseline, 8 weeks, 24 weeks |
| Change in perceived social support | 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. | Baseline, 8 weeks, 24 weeks |
| Self-rated health | 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. | Baseline, 8 weeks, 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. | 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. | 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. | 8 weeks and 24 weeks |
| Satisfaction with intervention | Net promoter score and questions about satisfaction with various intervention components. | 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 | 8 weeks and 24 weeks |