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NCT Number: NCT06226077

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

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Dyssomnias Insufficient Sleep Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Rachel Price, MPH

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase 1:

  • Not meeting Physical Activity Guidelines
  • age range: 21 to 75 years
  • body mass index: ≥25.0 kg/m2
  • average self-reported habitual sleep duration of ≤6 hours
  • self-identify as Black or African American

Phase 2:

  • Not meeting Physical Activity Guidelines
  • age range: 21 to 75 years
  • body mass index: ≥25.0 kg/m2
  • average self-reported habitual sleep duration of ≤6 hours
  • self-identify as Black or African American

Exclusion criteria

Phase 1:

  • Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  • pregnant or less than 4 months postpartum
  • infant living in household less than 1 year old

Phase 2:

  • Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
  • pregnant or less than 4 months postpartum
  • infant living in household less than 1 year old

Treatment and study plan

sleep extension intervention

Behavioral

The sleep intervention aims to increase sleep duration by one-hour (15 minutes/week) over the course of 4-weeks using components from Cognitive Behavioral Therapy for Insomnia. More specifically, the intervention consists of psychoeducation, sleep extension, sleep hygiene, and stimulus control. Participants will meet with Dr. Wu or a trained staff member once a week over the course of 4-weeks via Zoom. The intervention will be adapted based on feedback from the community, knowledge gained during previous interviews.

contact control intervention

Behavioral

The control condition is a contact-control intervention whereby participants will meet with Dr. Wu or a trained staff member once-week over the course of 4-weeks to receive education materials from the Healthy Homes intervention developed by the UT School of Public Health.

Primary outcomes

  1. Feasibility of the sleep intervention

    Time frame: 10 weeks

    feasibility is defined as 75% intervention attendance (3/4 sessions)

  2. Satisfaction with the sleep intervention

    Time frame: 10 weeks

    satisfaction is defined as Client Satisfaction Questionaire score >=20, range 8-32, with higher scores indicating higher satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Price, MPH

CONTACT

[email protected]

612-624-2254

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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