Clinical trial NCT06226077: Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
Official title: Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obesity
Insufficient Sleep
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is a 6-week (4-week intervention, 1- week pre/post actigraphy measurement) 2-armed randomized control trial with the sleep extension intervention in one arm, and then an education contact control in the second arm.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the sleep intervention
timeFrame: 10 weeks
measure: Satisfaction with the sleep intervention
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ivan Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: