Multidimensional Sleep Health Intervention for Couples

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07603245
Status
Not Yet Recruiting

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Conditions

  • Blood Pressure
  • Cardiovascular Health
  • Sleep

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Multidimensional Sleep Health Promotion Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Multidimensional Sleep Health (MDSH) Promotion Intervention
    Dyads will receive: 1. An 8-week multi-component multidimensional sleep health promotion intervention that includes: 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 and a participant manual, and inexpensive place-based solutions for light and noise as key upstream barriers to healthy sleep in urban settings. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Primary Outcome Measure

Change in office systolic blood pressure [ Time Frame: Baseline, 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032
Research Team
[email protected]
212-305-3317

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By research site
Columbia University· New York, NY

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