Insufficient Sleep, Obesity
Conditions
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.
Interventions
BEHAVIORALsleep extension intervention
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.
BEHAVIORALcontact control intervention
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the sleep intervention | 10 weeks | feasibility is defined as 75% intervention attendance (3/4 sessions) |
| 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. |
Countries
United States
Contacts
Primary ContactRachel Price, MPH
Outcome results
None listed