Embracing Morning BReakfast and Activity for Classroom Engagement

NCT06555627 | Recruiting

• 1 other identifier: 2024-0746
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Secondary Outcomes (6)

• 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 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.

• 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

• 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

Study Arms (4)

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

Behavioral: High Protein Breakfast; Behavioral: Morning Exercise

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.

Behavioral: High Protein Breakfast

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.

Behavioral: Morning Exercise; Behavioral: High Carb Breakfast

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.

Behavioral: High Carb Breakfast

Interventions

High Protein Breakfast BEHAVIORAL

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 and High Protein Breakfast; High Protein Breakfast Only

Morning Exercise BEHAVIORAL

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.

Exercise and High Carb Breakfast; Exercise and High Protein Breakfast

High Carb Breakfast BEHAVIORAL

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.

Exercise and High Carb Breakfast; High Carb Breakfast Only

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Enrolled at the participating school

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

Altus Academy

Chicago, Illinois, 60612, United States

RECRUITING

Study Officials

• Eduardo Bustamante

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Bustamante

CONTACT

312 371 5620; ebusta2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 15, 2024
• Study Start: February 3, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)