A Randomized Controlled Trial of Sleep Extension to Regulate Body Weight and Improve Learning in School-aged Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- BMI Z-score
研究概览
简要总结
More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 142 school-aged children (6-12 years) who have a BMI above average, defined as age- and sex-specific BMI Z-score above zero using WHO reference standards, and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=142).
The primary objective is to assess the effects of sleep extension by ~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who have a BMI for age and sex above average, and sleep less than recommended for their age.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 6-12 years old (inclusive range).
- •Weight status: having a BMI above average, defined as an age- and sex-specific BMI Z-score above zero using reference standards from the WHO.
- •Sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by the children's parents, based on recommendations by the American Academy of Sleep Medicine and the Sleep Health Foundation.
排除标准
- •Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, head trauma, β-thalassemia, hypothyroid-ism, hyperthyroidism, type I diabetes).
- •Any sleep-related disorder (for example: obstructive sleep apnea, parasomnias, narcolepsy, restless leg syndrome).
- •Regular use of prescribed or over-the-counter medications that influence study outcomes.
- •Irregular school schedule.
- •If a child's parents live separately, the child is allowed to sleep at both households. How-ever, if one of the parents does not wish to carry out the sleep intervention and follow given instructions, then the child should only sleep at their household Friday, Saturday and/or Sunday night.
- •In the circumstance where the child does not speak or understand Danish, the child's parents do not have to speak or understand Danish, as long as both parties can speak and understand English.
- •Participation in other research studies.
- •Metal implants and claustrophobia (only for substudy-II).
结局指标
主要结局
BMI Z-score
时间窗: Assessed at months 0, 3 and 9
BMI (in kg/m\^2) will be calculated from weight and height (secondary outcomes), and the age- and sex-specific BMI Z-score (in units of standard deviation from the reference population mean) will be computed using international (WHO) data
Learning ability: Explicit memory
时间窗: Assessed at months 0 and 3
Explicit memory assessed as 24h retention after word list memory encoding - I.e. total within and between session effect. Number of correctly recalled words in a 2-minute standardized task (range: from 0 to 20)
Learning ability: skill learning
时间窗: Assessed at months 0 and 3
Skill learning ability will be measured as motor memory assessed as 24h retention after skill practice - I.e. total within and between session effect (range: from "low" = 0 to "high" = 100, unitless)
次要结局
- Body fat percent(Assessed at months 0, 3 and 9)
- Total fat mass (FM)(Assessed at months 0, 3 and 9)
- Total lean mass (LM)(Assessed at months 0, 3 and 9)
- Bone mineral content (BMC)(Assessed at months 0, 3 and 9)
- Bone mineral density (BMD)(Assessed at months 0, 3 and 9)
- Dietary energy intake(Assessed at months 0, 3 and 9)
- Dietary protein, carbohydrate, fiber, and fat intakes(Assessed at months 0, 3 and 9)
- Subjective hunger(Assessed at months 0 and 3)
- Physical activity (PA) time: total PA and MVPA(Assessed at months 0, 1.5,3 and 9)
- Resting metabolic rate (RMR)(Assessed at months 0 and 3)
- Thermic effect of food (TEF)(Assessed at months 0 and 3)
- Weight(Assessed at months 0, 3 and 9)
- Height(Assessed at months 0, 3 and 9)
- Total energy expenditure (TEE)(Assessed at months 0 and 3)
- Cognitive functions: Sustained attention(Assessed at months 0, 3 and 9)
- Cognitive functions: Spatial working memory(Assessed at months 0, 3 and 9)
- Cognitive functions: Inhibitory control(Assessed at months 0, 3 and 9)
- Cognitive functions: Cognitive flexibility(Assessed at months 0, 3 and 9)
- School performance: mathematics performance(Assessed at months 0, 3 and 9)
- School performance: reading comprehension(Assessed at months 0, 3 and 9)
- Neurophysiological Measurement 1 - ERP Amplitude(Assessed at months 0 and 3)
- Neurophysiological Measurement 2 - Cortical activity during skill learning(Assessed at months 0 and 3)
- Neurophysiological Measurement 3 - Muscle activity during skill learning(Assessed at months 0 and 3)
- Neurophysiological Measurement 4 - corticocortical functional connectivity(Assessed at months 0 and 3)
- Neurophysiological Measurement 5 - corticomuscular connectivity(Assessed at months 0 and 3)
- Cognitive functions: Spatial working memory(Assessed at months 0, 3 and 9)
- Thermic effect of food (TEF)(Assessed at months 0 and 3)
- Body fat percent(Assessed at months 0, 3 and 9)
- Total fat mass (FM)(Assessed at months 0, 3 and 9)
- Total lean mass (LM)(Assessed at months 0, 3 and 9)
- Bone mineral content (BMC)(Assessed at months 0, 3 and 9)
- Bone mineral density (BMD)(Assessed at months 0, 3 and 9)
- Dietary energy intake(Assessed at months 0, 3 and 9)
- Dietary protein, carbohydrate, fiber, and fat intakes(Assessed at months 0, 3 and 9)
- Subjective hunger(Assessed at months 0 and 3)
- Physical activity (PA) time: total PA and MVPA(Assessed at months 0, 1.5,3 and 9)
- Resting metabolic rate (RMR)(Assessed at months 0 and 3)
- Weight(Assessed at months 0, 3 and 9)
- Height(Assessed at months 0, 3 and 9)
- Total energy expenditure (TEE)(Assessed at months 0 and 3)
- Cognitive functions: Sustained attention(Assessed at months 0, 3 and 9)
- Cognitive functions: Inhibitory control(Assessed at months 0, 3 and 9)
- Cognitive functions: Cognitive flexibility(Assessed at months 0, 3 and 9)
- School performance: mathematics performance(Assessed at months 0, 3 and 9)
- School performance: reading comprehension(Assessed at months 0, 3 and 9)
- Neurophysiological Measurement 1 - ERP Amplitude(Assessed at months 0 and 3)
- Neurophysiological Measurement 2 - Cortical activity during skill learning(Assessed at months 0 and 3)
- Neurophysiological Measurement 3 - Muscle activity during skill learning(Assessed at months 0 and 3)
- Neurophysiological Measurement 4 - corticocortical functional connectivity(Assessed at months 0 and 3)
- Neurophysiological Measurement 5 - corticomuscular connectivity(Assessed at months 0 and 3)
- Eating window(Assessed at months 0, 3 and 9.)