Increasing Childhood Sleep Duration in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Actigraphy Estimated Weeknight Sleep Duration
研究概览
简要总结
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.
详细描述
Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 9 to 12 years.
- •Speak, read and write in English.
- •Parental/guardian permission (informed consent) and child assent.
- •Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- •Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm & get out of bed at 6am).
排除标准
- •Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- •Diagnosed with a psychiatric disorder [e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety].
- •Diagnosed with an eating disorder.
- •Musculoskeletal or neurological disorder that limits physical movement and activity.
- •Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
研究组 & 干预措施
9h 15m Goal | Incentive A | Texts B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive B | Texts A&B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A | Texts A
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A | Texts A&B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A&B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A&B | Texts B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive A&B | Texts A
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentives A&B | Texts A&B
干预措施: Sleep Extension (Behavioral)
Personal Goal
干预措施: Sleep Extension (Behavioral)
Personal Goal | Texts B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Texts A
干预措施: Sleep Extension (Behavioral)
Personal Goal | Texts A&B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive B | Texts B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive B | Text A
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive B | Texts A&B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A | Texts B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A&B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A | Texts A
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A | Texts A&B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A&B | Texts B
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentive A&B | Texts A
干预措施: Sleep Extension (Behavioral)
Personal Goal | Incentives A&B | Texts A&B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive B | Texts B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Texts B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Texts A
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Texts A&B
干预措施: Sleep Extension (Behavioral)
9h 15m Goal | Incentive B | Texts A
干预措施: Sleep Extension (Behavioral)
结局指标
主要结局
Actigraphy Estimated Weeknight Sleep Duration
时间窗: 10 weeks
The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.
次要结局
- Sleep Disturbance Score(15 minutes)
- Sleep Related Impairment Score(15 minutes)