Multidimensional Sleep Health Intervention for Couples
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Multidimensional Sleep Health Promotion Intervention
BehavioralStandard 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Multidimensional Sleep Health (MDSH) Promotion InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in office systolic blood pressure
The change in office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
Time frame
Baseline, 8 weeks2
Change in office diastolic blood pressure
The change in office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
Time frame
Baseline, 8 weeks3
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 \< 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.
Time frame
Baseline, 8 weeks4
Change 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 will be assessed.
Time frame
Baseline, 8 weeksSecondary outcomes
1
Change in body weight
The change in body weight (lbs) from baseline to follow-up at 8 weeks will be calculated.
Time frame
Baseline, 8 weeks2
Change in waist circumference
The change in waist circumference (inches) from baseline to follow-up at 8 weeks will be calculated.
Time frame
Baseline, 8 weeks3
Change in diet quality
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.
Time frame
Baseline, 8 weeks4
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 will be calculated.
Time frame
Baseline, 8 weeksSponsors and contacts
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Source ClinicalTrials.gov