Projekt SHINE (Sleep Health Initiative for Equity): Kulturellt informera om en sömnförlängningsintervention för afroamerikanska vuxna
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55414
- University of Minnesota
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: sleep extension intervention arm
sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to the sleep 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. |
|
Aktiv komparator: education contact control arm
sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to contact 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of the sleep intervention
Tidsram: 10 weeks
|
feasibility is defined as 75% intervention attendance (3/4 sessions) |
10 weeks
|
|
Satisfaction with the sleep intervention
Tidsram: 10 weeks
|
satisfaction is defined as Client Satisfaction Questionaire score >=20, range 8-32, with higher scores indicating higher satisfaction. |
10 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ivan Wu, PhD, University of Minnesota
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2022LS170 (B)
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