A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Number of Enrollments in the Study Over One Year
研究概览
简要总结
The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. The study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. The intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.
详细描述
Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.
Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.
Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age must be 18-25 years old
- •Self-report short sleep
- •BMI ≥ 30 (the World Health Organization's classification of being obese)
- •Insulin Resistance determined by serum analysis
- •Be willing to extend time in bed by one hour total per night
- •Read and speak English.
排除标准
- •Night shift worker;
- •Sleep disorder diagnosis;
- •Medical diagnosis of diabetes or pre-diabetes;
- •Currently pregnant or lactating or with history of gestational diabetes;
- •Actively participating in a weight loss program;
- •Hospitalization in past 3 months for any medical or psychiatric condition;
- •Having a major chronic illness (e.g. cancer, Lupus)
结局指标
主要结局
Number of Enrollments in the Study Over One Year
时间窗: Up to 12 months
Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.
Number of Participants Enrolled in the Intervention Arm Who Complete the Study
时间窗: Week 4
Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.
次要结局
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores(Baseline, Week 4)
- Hours of Sleep(Over a 1 week period at Baseline, and over a 1 week period at Week 4)
- Number of Participants Extending Sleep(Over a 1 week period at Baseline, and over a 1 week period at Week 4)
研究者
Ashley Coombe
Assistant Professor
Emory University