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

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obesity; Insufficient Sleep

Treatments: Behavioral: sleep extension intervention; Behavioral: contact control intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06226077

2022LS170 (B)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

sleep extension intervention arm

Experimental group

Description:

sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.

Treatment:

Behavioral: sleep extension intervention

education contact control arm

Active Comparator group

Description:

sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

Treatment:

Behavioral: contact control intervention