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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sleep extension intervention arm | Experimental | sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention. |
|
| education contact control arm | Active Comparator | sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the sleep intervention | feasibility is defined as 75% intervention attendance (3/4 sessions) | 10 weeks |
| Satisfaction with the sleep intervention | satisfaction is defined as Client Satisfaction Questionaire score >=20, range 8-32, with higher scores indicating higher satisfaction. | 10 weeks |
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Inclusion Criteria:
Phase 1:
Phase 2:
Exclusion Criteria:
Phase 1:
Phase 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Price, MPH | Contact | 612-624-2254 | price919@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ivan Wu, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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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.
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|
| 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. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
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