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Behavioural Intervention

Sleep Health for Heart and Metabolic Health

N/A

Waitlist Available

Led By Nour Makarem, PhD, FAHA

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 20 years or older

Be older than 18 years old

Must not have

History of cardiovascular disease or cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10 weeks, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve heart and metabolic health by focusing on sleep along with diet and exercise. The study, called Sleep2BWell, will add sleep education sessions, Fitbit monitoring, and addressing

Who is the study for?

The Sleep2BWell trial is for individuals interested in improving their sleep, diet, physical activity, and reducing high blood pressure. Participants will be from underserved NYC neighborhoods and involved with faith-based organizations or community centers. They should be willing to engage in a 6-week program involving education sessions, self-monitoring with Fitbit devices, and addressing environmental factors affecting sleep.

What is being tested?

This study tests if adding sleep health components to the BWell4Life program can better improve cardiometabolic health (CMH). It compares two groups: one follows the standard BWell4Life plan focusing on diet and exercise; the other adds sessions on sleep health plus tools like Fitbits to monitor progress.

What are the potential side effects?

Since this trial involves non-medical interventions such as lifestyle coaching and monitoring via Fitbit, side effects are minimal but may include discomfort due to changes in diet or increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 20 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in systolic blood pressure

Secondary study objectives

Acceptability of Implementation

Appropriateness of Implementation

Change in alertness

+13 more

Other study objectives

Change in allostatic load

Change in fasting glucose

Change in total cholesterol

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep2BWell Intervention ArmExperimental Treatment3 Interventions

Sleep2BWell is a 6-week program, which consists of the 4-wk BWell4Life program enhanced with two sleep health education and group coaching sessions and addressing structural barriers to healthy sleep in NYC (light, noise, and indoor air pollution). The sleep health education sessions will incorporate didactic content, engaging animated videos, group coaching, and an interactive Q\&A period. These sessions will incorporate techniques to establish regular bed and wake times, learn wind-down and wake-up routines, cope with stress through muscle relaxation and mindfulness techniques, and optimize the sleep environment. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring. They will also receive a sleep mask, ear plugs, a blue light blocker, and an indoor air purifier to address barriers to healthy sleep in the sleep environment.

Group II: BWell4Life Control ArmActive Control2 Interventions

BWell4Life is a 4-week community health promotion program focused on lifestyle change through consumption of a healthy diet and being physically active through weekly educational sessions, setting specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, and didactic content based on the American Heart Association (AHA) Life's Essential 8 framework. The two diet sessions include an overview of nutrition basics, examples of healthy dietary patterns and cooking methods to increase consumption of plant-based foods and healthy proteins and reduce intakes of red and processed meats, sugary foods, and sugar-sweetened beverages. The two physical activity sessions provide an overview of the physical activity guidelines and include 30-60 minutes of exercise. These sessions also address achieving and maintaining a healthy body weight. Participants will receive a Fitbit for self-monitoring and collecting sleep health and physical activity data.

0 / 2Eligibility criteria met