Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
研究概览
简要总结
This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test study design will test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 40 years of age and less than or equal to 60 years of age.
- •Objectively confirmed MetS defined by three or more of the following:
- •waist circumference greater than 120cm (men) or 88cm (women),
- •blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use,
- •fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use,
- •serum triglycerides greater than or equal to 150mg/dL or hypertriglyceridia medication use,
- •HDL-c less than 40mg/dL (women) or less than 50 mg/dL (men) or medication use for low HDL-c
- •MetS was selected because individuals with MetS are at high risk for multiple chronic conditions
- •No obstructive sleep apnea.
- •Accelerometry confirmed short sleep (average work day sleep less than or equal to 6 hours/night).
- •English speaking.
排除标准
- •Pregnancy/lactation
- •Current chemotherapy treatments
- •Alcohol abuse/dependence
- •Night shift or shift work (previous 2 months)
- •trans-meridian travel (previous 4 weeks),
- •planned shift work or trans-meridian travel during intervention period
- •Moderate-severe or severe depression
- •Sleep-promoting medications
- •Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of the week.
结局指标
主要结局
Measure of acceptability Post Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
时间窗: 4 Months
Acceptable (overall acceptability survey scores greater than 21), neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey scores less than 21) at each of two time points (pre- intervention and post intervention).
Measure of acceptability Pre-Intervention evaluated by the percentage of participants rating SASI as acceptable, neutral, unacceptable
时间窗: 0 Months
Acceptable (overall acceptability survey scores greater than 21), neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey scores less than 21) at each of two time points
次要结局
未报告次要终点