RECRUITING

Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial. The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention. There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.

Official Title

Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

Quick Facts

Study Start:2023-10-01
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06226077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Not meeting Physical Activity Guidelines
  2. * age range: 21 to 75 years
  3. * body mass index: ≥25.0 kg/m2
  4. * average self-reported habitual sleep duration of ≤6 hours
  5. * self-identify as Black or African American
  6. * Not meeting Physical Activity Guidelines
  7. * age range: 21 to 75 years
  8. * body mass index: ≥25.0 kg/m2
  9. * average self-reported habitual sleep duration of ≤6 hours
  10. * self-identify as Black or African American
  1. * Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  2. * pregnant or less than 4 months postpartum
  3. * infant living in household less than 1 year old
  4. * Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  5. * pregnant or less than 4 months postpartum
  6. * infant living in household less than 1 year old

Contacts and Locations

Study Contact

Rachel Price, MPH
CONTACT
612-624-2254
price919@umn.edu

Principal Investigator

Ivan Wu, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Ivan Wu, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Insufficient Sleep