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Search / Trial NCT06565104

The Sleep2BWell Trial

Launched by COLUMBIA UNIVERSITY · Aug 19, 2024

Trial Information

Current as of May 14, 2025

Active, not recruiting

Keywords

ClinConnect Summary

The Sleep2BWell Trial is a research study aimed at improving health related to blood pressure and sleep by adding a sleep health program to an existing lifestyle change program called BWell4Life. This program already focuses on healthy eating and physical activity. In Sleep2BWell, participants will receive extra support for better sleep, including educational sessions, group coaching, and tools like a Fitbit to track their sleep and activity. The study will also address common challenges to getting good sleep, such as noise and light, particularly in urban areas. Researchers will look at how these changes impact overall health, including blood pressure, diet, and physical activity.

To join the study, participants need to be at least 20 years old, speak English and/or Spanish, and have elevated blood pressure (at least 120 mmHg). Those with certain health conditions or who are pregnant cannot participate. The study is taking place in community centers in underserved neighborhoods of New York City, with about 210 people expected to take part. Throughout the trial, participants will be monitored for changes in their sleep and health behaviors, with follow-ups at 10 weeks and 24 weeks to see how effective the program has been. This trial aims to find new ways to improve health in communities and help close the gap in health disparities.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. English- and/or Spanish-speaking
  • 2. aged ≥20 years
  • 3. having at minimum SBP in the elevated or hypertension category (i.e., SBP ≥120 mmHg)
  • Exclusion Criteria:
  • 1. No known medical conditions that would prevent them from safely participating in the trial (e.g., neurological degenerative disease such as Parkinsons, severe psychiatric disorders, substance use disorder)
  • 2. History of cardiovascular disease or cancer
  • 3. Pregnant or desire to become pregnant during the study
  • 4. Less than one year postpartum

About Columbia University

Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.

Locations

New York, New York, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported