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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of Minnesota

About this trial

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

Qualifiers

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

Disqualifiers

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

Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)

Trial design

Treatments tested in this trial

  • sleep extension intervention
  • contact control intervention

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators