Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 4
- 主要终点
- Change in Sleep Duration
研究概览
简要总结
The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-11 years old
- •BMI for age and gender > 10th percentile (but no greater than 100% overweight)
- •Sleep 9.5 hours or less nightly
- •Attend elementary school
- •Like at least 1 food used in the reinforcement paradigm
- •Able to understand and complete the reinforcement paradigm
排除标准
- •Existence of a diagnosable parasomnia, sleep disordered breathing
- •Medical or psychiatric condition that could influence sleep or weight
- •Inability to complete study materials, including diagnosed disabilities
- •Dietary restrictions/allergies to foods used in the study that preclude them from study participation
结局指标
主要结局
Change in Sleep Duration
时间窗: Baseline, 2-weeks, and 2-months
Measured with actigraphy
Change in Dietary Intake
时间窗: Baseline, 2-weeks, and 2-months
Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)
次要结局
- Change in zBMI(Baseline, 2-week, and 2-month)
- Change in activity(Baseline, 2-week, and 2-month)
- Change in the Reinforcing Value of Food(Baseline, 2-weeks, and 2-months)