The DREAM Study: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health
ConditionBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 30+ years
English or Spanish speaking
Systolic blood pressure greater than or equal to 120 mmHg
Sub-optimal sleep health
Disqualifiers
Optimal sleep health
History of cardiovascular disease or cancer
Non-English or non-Spanish speaking
Not cognitively able to complete study requirements
Trial design
Design model
Parallel
Treatments tested in this trial
Multidimensional Sleep Health Promotion Intervention
BehavioralMulti-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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Multidimensional Sleep Health Promotion InterventionExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline, 8 weeksSecondary outcomes
1
Change in office systolic blood pressure (sustained effect at 24 weeks)
The change office systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.
Time frame
Baseline, 24 weeks2
Change in office diastolic blood pressure
The change office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Time frame
Baseline, 8 weeks, and 24 weeks3
Change in daytime blood pressure (during wake)
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 and 24 weeks will be calculated and compared across randomization arms.
Time frame
Baseline, 8 weeks, and 24 weeks4
Change in nighttime blood pressure (during sleep)
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 out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Time frame
Baseline, 8 weeks, 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov