NCT06285968

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

February 13, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

March 12, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

February 13, 2024

Last Update Submit

November 20, 2025

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (13)

  • Change in office systolic blood pressure (sustained effect at 24 weeks)

    Baseline, 24 weeks

  • Change in office diastolic blood pressure

    Baseline, 8 weeks, and 24 weeks

  • Change in out-of-office blood pressure

    Baseline, 8 weeks, and 24 weeks

  • Change in fasting glucose

    Baseline, 8 weeks, and 24 weeks

  • Change in body weight

    Baseline, 8 weeks, and 24 weeks

  • +8 more secondary outcomes

Study Arms (2)

Multidimensional Sleep Health Promotion Intervention

EXPERIMENTAL

Participants randomized to the intervention arm will receive: 1. A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Behavioral: Multidimensional Sleep Health Promotion Intervention

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.

Interventions

Multidimensional Sleep Health Promotion InterventionBEHAVIORAL

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.

Multidimensional Sleep Health Promotion Intervention

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 30-65 years
  • English or Spanish speaking
  • Systolic blood pressure greater than or equal to 120 mmHg
  • Sub-optimal sleep health
  • No history of overt cardiovascular disease
  • No history of cancer

You may not qualify if:

  • Optimal sleep health
  • History of cardiovascular disease or cancer
  • Non-English or non-Spanish speaking
  • Not cognitively able to complete study requirements
  • Severe psychiatric disorders
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center, Mailman School of Public Health

New York, New York, 10032, United States

RECRUITING

Study Officials

  • Nour Makarem, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Project Coordinator

CONTACT

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

Nour Makarem, PhD

CONTACT

nm2968@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Epidemiology

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 29, 2024

Study Start

March 12, 2024

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

US(1)