Blood Pressure, Cardiovascular Health, Sleep
Conditions
Keywords
Blood Pressure, Sleep, Cardiovascular Health, Couples, Dyads
Brief summary
The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects. Can a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners? Can a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners? As this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.
Detailed description
Sleep is a critical determinant of cardiometabolic health (CMH), yet most lifestyle interventions have focused exclusively on diet and physical activity, ignoring sleep as a modifiable behavioral target. There are limited behavioral sleep health interventions for improving CMH. To address this, the investigators developed the DREAM intervention, a multilevel multi-component intervention leveraging evidence-based behavior change techniques and addressing both individual behaviors and the sleep environment. To extend this work, the investigators are adapting the DREAM intervention to cohabitating couples, recognizing the critical role of dyadic dynamics in shaping sleep health and the importance of relationship partners in influencing each other's health behaviors. This study will investigate whether a dyadic multidimensional sleep health (MDSH) intervention delivered to cohabitating relationship partners can improve objectively measured sleep health and cardiometabolic outcomes, including office and out-of-office blood pressure (BP) and anthropometric markers of adiposity. This study will also examine the intervention's effects on stress, psychosocial indicators, dyadic adjustment and coping, and self-rated health. The hypothesis is that targeting multiple interrelated sleep dimensions and leveraging health-promoting dyadic dynamics as a sustainable social support mechanism will improve MDSH and CMH. This is a single arm, pre-post design intervention study. There is no randomization or control arm, and all eligible couples will receive the MDSH intervention. The study consists of three phases: Screening Phase: Online/phone questionnaire screening followed by an in-person blood pressure assessment and 7-day sleep assessment (actigraphy and sleep diary) to confirm eligibility. Intervention Phase (8 weeks): Eligible couples receive the full MDSH intervention, and complete two in-person visits at baseline and 8-weeks (endpoint). Follow-Up Phase (16 weeks): A follow-up phone call is conducted at 16 weeks post-enrollment to collect sleep health information and assess sustainability of intervention effects.
Interventions
Standard American Heart Association (AHA) Life's Essential 8 (LE8) cardiovascular health educational materials and the 8-week MDSH intervention using evidence-based sleep hygiene education and established behavior change techniques that include: report back of objectively-assessed sleep health profiles, goal setting and dyadic MDSH planning, behavioral coaching (enhancing dyadic coping, communication, collaborative support) and sleep health education sessions, self-monitoring and motivational enhancement using a Fitbit, weekly check-in calls, and a participant sleep health manual, and inexpensive place-based solutions for light, and noise as key upstream barriers to healthy sleep in urban settings.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 30-65 years * English-speaking * Sub-optimal sleep health (at minimum one individual has to meet: short/long sleep duration and/or irregular sleep patterns)
Exclusion criteria
* Optimal sleep health * History of cardiovascular disease or cancer * Not cognitively able to complete study requirements * Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse/dependence) * History of severe depression * High risk of sleep apnea or use of a Continuous Positive Airway Pressure (CPAP) device * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in office systolic blood pressure | Baseline, 8 weeks | The change in office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads. |
| Change in office diastolic blood pressure | Baseline, 8 weeks | The change in office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads. |
| Change in multidimensional sleep health | Baseline, 8 weeks | 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 \< 60 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 or quality. Each individual component will receive a score of 1 if it meets the optimal sleep health definition or a score of 0 if it does not. Scores will range from 0-6, where higher scores (closer to 6) are defined as healthier sleep. Changes in the sleep health score (cumulative dimensions) from baseline to 8 weeks will be assessed. |
| Change in sleep duration | Baseline, 8 weeks | 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 will be assessed. |
| Change in sleep regularity | Baseline, 8 weeks | 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 standard deviation (SD) and sleep timing SD (continuous variable) from baseline to 8 weeks will be assessed. |
| Changes in sleep efficiency | Baseline, 8 weeks | 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 will be assessed. |
| Changes in sleep timing | Baseline, 8 weeks | 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 will be assessed. |
| Changes in sleep alertness | Baseline, 8 weeks | 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 will be assessed. |
| Change in sleep satisfaction | Baseline, 8 weeks | Sleep satisfaction will be assessed from the consensus sleep diary. Sleep satisfaction is measured on a Likert scale (1 = very poor; 2 = poo; 3 = fair; 4 = good; 5 = very good). Change in sleep satisfaction from baseline and 8 weeks will be assessed. |
| Change in subjective sleep quality | Baseline, 8 weeks, 16 weeks | 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 will be computed. |
| Change in daytime blood pressure (during wake) | Baseline, 8 weeks | 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 will be calculated. |
| Change in nighttime blood pressure (during sleep) | Baseline, 8 weeks | 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 these out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks will be calculated. |
| Change in mean 24-hour blood pressure | Baseline, 8 weeks | 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 will be calculated and compared across dyads. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, 8 weeks | The change in body weight (lbs) from baseline to follow-up at 8 weeks will be calculated. |
| Change in waist circumference | Baseline, 8 weeks | The change in waist circumference (inches) from baseline to follow-up at 8 weeks will be calculated. |
| Change in diet quality | Baseline, 8 weeks | The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to 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 will be calculated. |
| Change in perceived stress | Baseline, 8 weeks | 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 will be calculated. |
| Change in anxiety severity | Baseline, 8 weeks | 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 will be calculated. |
| Change in depression severity | Baseline, 8 weeks | 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 will be calculated. |
| Change in dyadic coping | Baseline, 8 weeks | The Dyadic Coping Inventory (DCI) is a self-report measure of stress communication and positive and negative forms of dyadic coping. This will be used to assess how couples manage stress together. DCI scores range from 35 to 145, with a higher score indicates higher dyadic coping, and DCI \< 111 indicating low dyadic coping. The change in DCI scores from baseline to 8 weeks will be calculated. |
| Change in dyadic adjustment | Baseline, 8 weeks | The Dyadic Adjustment Scale (DAS) measures relationship quality covering 4 subscales consensus, satisfaction, cohesion, and affectional. This will be used to measure the quality of marriage and similar intimate relationships. The DAS score ranges from 0 to 151, where a higher DAS score indicates better adjustment, and DAS \< 98 indicating significant relationship distress/discord. The change in DAS scores from baseline to 8 weeks will be calculated. |
| Change in self-rated health | Baseline, 8 weeks | Self-rated health will be measured using self-reported health on a Likert scale (excellent, very good, good, fair, poor) where 1 = Excellent and 5 = Poor. The change in self-rated health from baseline to 8 weeks will be calculated. |
| Acceptability of Intervention | Baseline, 8 weeks | 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. |
| Feasibility of Implementation | Baseline, 8 weeks | 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 total score. |
| Appropriateness of Implementation | Baseline, 8 weeks | 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 "Complete disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score. |
| Satisfaction with Intervention | Baseline, 8 weeks | Participants' satisfaction with the study intervention will be assessed using the net promoter score, measured on a scale of 0 to 10. A higher score indicates greater satisfaction. |
Countries
United States
Contacts
CONTACTResearch Team
PRINCIPAL_INVESTIGATORNour Makarem, PhD
Columbia University
Outcome results
None listed