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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: sleep extension intervention armExperimental treatment 1 intervention
Group B: education contact control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the sleep intervention

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

Time frame
10 weeks
2

Satisfaction with the sleep intervention

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

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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