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临床试验/NCT05698693
NCT05698693已完成1 期

Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults

University of Minnesota2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
80
试验地点
2
主要终点
Feasibility

研究概览

简要总结

African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not meeting Physical Activity Guidelines
  • age range: 21 to 65 years
  • body mass index range: 25.0 to 40 kg/m2
  • average self-reported habitual sleep duration of ≤6 hours
  • self-identify as Black or African American.

排除标准

  • 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

研究组 & 干预措施

Sleep intervention

Experimental

The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends.

干预措施: Sleep intervention (Behavioral)

Contact control

Active Comparator

The content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion.

干预措施: Contact Control (Behavioral)

结局指标

主要结局

Feasibility

时间窗: 4 weeks

Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.

Satisfaction

时间窗: 4 weeks post-intervention

Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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