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临床试验/NCT06555627
NCT06555627已完成不适用

Project EMBRACE: Embracing Morning BReakfast and Activity for Classroom Engagement

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Behavioral Observation of Students in Schools (BOSS) - Classroom Engagement (Shapiro et al., 2003)

研究概览

简要总结

This experiment will test the effects of healthy breakfast and morning exercise on children's focus and classroom behavior. Food and exercise each influence child focus, but little is known about their effects on classroom behavior and less about their combined effects. For one week (Monday-Friday), 10 children will be randomly assigned to receive healthy breakfast and morning exercise, 10 assigned to only healthy breakfast, 10 to only exercise, and 10 to neither. After exercise and breakfast, study staff will assess how focused children are during class-time, ask them to complete puzzle-like tasks, and wear a helmet that measures brain blood flow

详细描述

Specific Aims:

Specific Aim 1: Determine the independent and convergent effects of breakfast and exercise on child classroom behavior using systematic classroom observations.

Hypothesis 1: Groups assigned to receive protein-rich breakfast (1 & 3) will demonstrate greater engagement and reduced off-task behavior compared with those receiving high carb breakfast (groups 2 & 4) (the main effect of high-protein breakfast). Groups receiving morning exercise (2 & 3) will demonstrate great engagement and reduced off-task behavior compared with groups not receiving exercise (1 & 4) (main effect of exercise). Children receiving both exercise and breakfast (group 3), will demonstrate greater improvements than those receiving just one (1 vs. 3 & 2 vs. 3), the interaction effect.

Specific Aim 2: Determine the independent and convergent effects of breakfast and physical activity on inhibitory control and attention using computerized executive function tasks.

Hypothesis 2: It is hypothesized that our data will show a main effect of protein rich breakfast on neuropsychological task performance (groups 1 & 3 vs. groups 2 & 4), a main effect of morning exercise (2 & 3 vs. 1 & 4), and an interaction effect favoring the combination of breakfast and exercise beyond either in isolation (3 vs. 1, 3 vs. 2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •6-11 years old
  • •Enrolled at the participating school

排除标准

  • •Younger than 5 years old
  • •Older than 12 years old
  • •Not enrolled in a participating school
  • •Allergic to dairy or gluten

研究组 & 干预措施

Exercise and High Protein Breakfast

Experimental

Children in this group will be given given breakfast each morning at 7:30 am and participate in a 30-minute bout of physically active games of moderate to vigorous intensity at 8 am.

Nutrition Intervention. For 5 days children will receive a high protein breakfast comprised of baked items (i.e. waffles with syrup) and Greek yogurt. The high protein meal will aim for 40% protein, 40% carbohydrates, and 20% fat. Meals will be served with a cup of water.

Exercise Intervention. For 5 days, a 30-min physical activity bout including a 5-minute warm up and cool down will be provided to participants in this group. The aim is for students to achieve an average heart rate above 150 for the session, not including warm up or cool down. To monitor intensity, the participant will wear heart rate monitors around their chest and waist-worn accelerometers

干预措施: High Protein Breakfast (Behavioral)

Exercise and High Protein Breakfast

Experimental

Children in this group will be given given breakfast each morning at 7:30 am and participate in a 30-minute bout of physically active games of moderate to vigorous intensity at 8 am.

Nutrition Intervention. For 5 days children will receive a high protein breakfast comprised of baked items (i.e. waffles with syrup) and Greek yogurt. The high protein meal will aim for 40% protein, 40% carbohydrates, and 20% fat. Meals will be served with a cup of water.

Exercise Intervention. For 5 days, a 30-min physical activity bout including a 5-minute warm up and cool down will be provided to participants in this group. The aim is for students to achieve an average heart rate above 150 for the session, not including warm up or cool down. To monitor intensity, the participant will wear heart rate monitors around their chest and waist-worn accelerometers

干预措施: Morning Exercise (Behavioral)

High Protein Breakfast Only

Active Comparator

Nutrition Intervention. For 5 days children will receive a high protein breakfast comprised of baked items (i.e. waffles with syrup) and Greek yogurt. The high protein meal will aim for 40% protein, 40% carbohydrates, and 20% fat. Meals will be served with a cup of water.

干预措施: High Protein Breakfast (Behavioral)

Exercise and High Carb Breakfast

Active Comparator

Exercise Intervention. For 5 days, a 30-min physical activity bout including a 5-minute warm up and cool down will be provided to participants in this group. The aim is for students to achieve an average heart rate above 150 for the session, not including warm up or cool down. To monitor intensity, the participant will wear heart rate monitors around their chest and waist-worn accelerometers.

For 5 days children will receive a high carb breakfast that will be comprised of 15% protein, 65% carbohydrates and 20% fat. Total energy content, fat, sugar, fiber, energy density, are similar between the breakfast meals.

干预措施: Morning Exercise (Behavioral)

Exercise and High Carb Breakfast

Active Comparator

Exercise Intervention. For 5 days, a 30-min physical activity bout including a 5-minute warm up and cool down will be provided to participants in this group. The aim is for students to achieve an average heart rate above 150 for the session, not including warm up or cool down. To monitor intensity, the participant will wear heart rate monitors around their chest and waist-worn accelerometers.

For 5 days children will receive a high carb breakfast that will be comprised of 15% protein, 65% carbohydrates and 20% fat. Total energy content, fat, sugar, fiber, energy density, are similar between the breakfast meals.

干预措施: High Carb Breakfast (Behavioral)

High Carb Breakfast Only

Placebo Comparator

For 5 days children will receive a high carb breakfast that will be comprised of 15% protein, 65% carbohydrates and 20% fat. Total energy content, fat, sugar, fiber, energy density, are similar between the breakfast meals.

干预措施: High Carb Breakfast (Behavioral)

结局指标

主要结局

Behavioral Observation of Students in Schools (BOSS) - Classroom Engagement (Shapiro et al., 2003)

时间窗: Classroom observations will occur between 9:00am and 11:30am on 3 days during the baseline week and on 3 days during the intervention week.

The Behavioral Observation of Students in Schools (BOSS) (Shapiro et al., 2003) is a systematic observation tool that assesses children's classroom behavior, including active and passive engagement, and the frequency of three kinds of off-task behavior: motor, verbal, and passive. The primary outcome in this study will be engaged time during instruction this will add up actively and passively engaged time and be represented by the percentage of time during instruction that students are engaged in instruction. The BOSS provides the percentage of observation intervals during which children are engaged in instruction (0%-100%) and a higher percentage is better.

次要结局

  • Neurocognitive inhibition test - Go/No-go(Neurocognitive testing will occur on Friday morning between 9am and 11:30am during the baseline testing week and then again the following Friday at the same time during the intervention week)
  • Behavioral Observation of Students in Schools (BOSS) - Off-Task Verbal (Shapiro et al., 2003)(Classroom observations will occur between 9:00am and 11:30am on 3 days during the baseline week and on 3 days during the intervention week.)
  • Brain blood flow as assessed by functional near infrared spectroscopy (fNIRS)(Neurocognitive testing, including fNIRS will occur on Friday morning between 9am and 11:30am during the baseline testing week and then again the following Friday at the same time during the intervention week)
  • Behavioral Observation of Students in Schools (BOSS) - Off-Task Motor (Shapiro et al., 2003)(Classroom observations will occur between 9:00am and 11:30am on 3 days during the baseline week and on 3 days during the intervention week.)
  • Behavioral Observation of Students in Schools (BOSS) - Off-Task Passive (Shapiro et al., 2003)(Classroom observations will occur between 9:00am and 11:30am on 3 days during the baseline week and on 3 days during the intervention week.)
  • Neurocognitive inhibition test - Fishy Flanker Test(Neurocognitive testing will occur on Friday morning between 9am and 11:30am during the baseline testing week and then again the following Friday at the same time during the intervention week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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