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Behavioral Intervention

Morning Exercise and Breakfast for Child Development

N/A

Waitlist Available

Led By Eduardo Bustamante

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6-11 years old

Be younger than 18 years old

Must not have

Older than 12 years old

Younger than 5 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

This trial will study how eating a healthy breakfast and doing morning exercise can impact children's focus and behavior in the classroom. The researchers are interested in understanding how food and exercise separately affect focus, as well

Who is the study for?

This trial is for children to explore how a healthy breakfast and morning exercise might affect their focus and behavior in the classroom. Kids must be able to eat both high-protein and high-carb meals, participate in physical activity, and commit to a one-week study period.

What is being tested?

The study tests the combined effect of a nutritious breakfast and morning exercise on child development. It randomly assigns kids into four groups: both interventions, just breakfast, just exercise, or neither. Their attention during class and brain blood flow are monitored.

What are the potential side effects?

Since this trial involves common activities like eating breakfast and exercising, side effects are minimal but could include typical reactions such as food sensitivities or minor injuries from physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am older than 12 years.

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I am under 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Behavioral Observation of Students in Schools (BOSS) - Off-Task Motor (Shapiro et al., 2003)

Behavioral Observation of Students in Schools (BOSS) - Off-Task Passive (Shapiro et al., 2003)

Behavioral Observation of Students in Schools (BOSS) - Off-Task Verbal (Shapiro et al., 2003)

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Exercise and High Protein BreakfastExperimental Treatment2 Interventions

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

Group II: High Protein Breakfast OnlyActive Control1 Intervention

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.

Group III: Exercise and High Carb BreakfastActive Control2 Interventions

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.

Group IV: High Carb Breakfast OnlyPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Protein Breakfast

2013

N/A

~40

Morning Exercise

2017

N/A

~70