Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
- Conditions
- ObesityInsufficient Sleep
- Interventions
- Behavioral: contact control interventionBehavioral: sleep extension intervention
- Registration Number
- NCT06226077
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description education contact control arm contact control intervention sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention. sleep extension intervention arm sleep extension intervention sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.
- Primary Outcome Measures
Name Time Method Satisfaction with the sleep intervention 10 weeks satisfaction is defined as Client Satisfaction Questionaire score \>=20, range 8-32, with higher scores indicating higher satisfaction.
Feasibility of the sleep intervention 10 weeks feasibility is defined as 75% intervention attendance (3/4 sessions)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States