A Behavioral Intervention to Improve the Sleep Health of Adults With Obesity: A Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Completeness of questionnaire responses
研究概览
简要总结
This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.
详细描述
Aim 1 (Primary): Examine the feasibility and acceptability of TranS-C among adults with poor sleep health and excess weight.
Aim 2 (Exploratory): Explore the effect of TranS-C on the sleep health of adults with poor sleep and excess weight.
Aim 3 (Exploratory): Explore the effect of TranS-C on the cardiometabolic health of adults with poor sleep and excess weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently own and regularly use a smart phone
- •Body mass index >27 and ≤ 43
- •Poor sleep health on one or more of the sleep health dimensions
排除标准
- •Presence of an unstable condition requiring physician-supervised diet and exercise
- •Physical limitations precluding ability to engage in moderate-intensity physical activity
- •Pregnant or intention to become pregnant during study
- •Current treatment for a serious mental illness
- •Being a current shift worker
- •Reported alcohol intake > 4 drinks/day for males and > 3 drinks/day for females
- •Current participation in a formal weight loss program, loss of ≥ 5% weight in past 6 months, or current use of weight loss medication
- •History of bariatric surgery
- •Planned extended vacations, absences, or relocation during study
- •Another member of household is a participant in the study
- •Score > 32 on the Eating Habits Checklist, an eating disorder scale
结局指标
主要结局
Completeness of questionnaire responses
时间窗: 6-months
Percentage of completed responses
Recruitment rate
时间窗: 6-months
Percentage of potential participants screened in order to enroll 10 participants
Attrition rate
时间窗: 6-months
Percentage of enrolled participants completing the 8-week intervention
次要结局
- Change in body mass index(8-weeks (baseline to post-intervention))
- Change in sleep timing(8-weeks (baseline to post-intervention))
- Change in sleep efficiency(8-weeks (baseline to post-intervention))
- Change in sleep duration(8-weeks (baseline to post-intervention))
- Change in composite sleep health score(8-weeks (baseline to post-intervention))
- Change in sleep regularity(8-weeks (baseline to post-intervention))
- Change in sleep satisfaction(8-weeks (baseline to post-intervention))
- Change in alertness(8-weeks (baseline to post-intervention))
- Change in systolic and diastolic blood pressure (BP)(8-weeks (baseline to post-intervention))
- Change in waist circumference(8-weeks (baseline to post-intervention))
研究者
Christopher Imes
Assistant Professor
University of Pittsburgh