Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 30 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adults aged 30-65 years - English-speaking - Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad) - Sub-optimal sleep health (at minimum 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 or high risk of sleep apnea/use of a Continuous Positive Airway Pressure (CPAP) device - Inability to provide informed consent

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Multidimensional Sleep Health Promotion Intervention
    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.

Recruiting Locations

Columbia University
New York, New York 10032
Contact:
Research Team
212-305-3317
dream@cumc.columbia.edu

More Details

Status
Recruiting
Sponsor
Columbia University

Study Contact

Research Team
212-305-3317
dream@cumc.columbia.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.