Child DevelopmentNCT06555627
Embracing Morning BReakfast and Activity for Classroom Engagement
A study testing High Protein Breakfast, Morning Exercise and High Carb Breakfast in people with Child Development, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- High Protein Breakfast, Morning Exercise and High Carb Breakfast
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-11 years old
- Enrolled at the participating school
Who cannot join
- Younger than 5 years old
- Older than 12 years old
- Not enrolled in a participating school
- Allergic to dairy or gluten
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project EMBRACE: Embracing Morning BReakfast and Activity for Classroom Engagement
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
Read the detailed description
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).
Specific Aim 3: Explore potential changes in brain activity by assessing blood flow via functional near-infrared spectroscopy (fNIRS) in the prefrontal cortex, while completing the computerized cognitive tasks.
Hypothesis 3: Results are expected to evidence similar patterns as aims 1 and 2, such that blood flow in the prefrontal cortex, will increase more in groups receiving both, relative to those receiving just one, and those receiving neither. Relationships between cerebral blood flow, task performance, and classroom behavior will be assessed.
Background:
Strong experimental and observational evidence supports connections between nutrition, physical activity, and neurocognitive development. In fact, one of the first interventions to show that exercise improves cognitive abilities in elementary-aged children was conducted at the University of Illinois Urbana Champaign, and several subsequent studies have replicated these results. Many studies assessing diet quality indicate a clear link between diet quality and cognition in children. While these outcomes are important for researchers, their perceived importance to parents and teachers lies in their promise to influence academic outcomes. For example, exercise improves cognitive inhibition on lab-based tasks, but teachers want to see that the benefit generalizes to raising their hands before speaking. Here, there is surprisingly little data, limiting adoption of interventions.
Another consideration regarding health behaviors is socioeconomic status, as individuals from low income neighborhoods as well as racial/ethnic minorities have shown to have poorer dietary patterns, lower rates of physical activity, and higher rates of obesity, making children in these groups particularly vulnerable to falling behind in academic achievement and cognitive development. Thus, interventions to improve such health behaviors ought to target children representing these populations as they likely have the most gain from healthy lifestyle changes.
Finally, interventions conducted in schools are particularly advantageous as children spend most of their day in schools not only during instruction but also before and after school as childcare while parents are working. Lastly, while many observational and experimental studies show clear diet-cognition and exercise-cognition interactions, these are almost always studied in isolation without examining combined effects. Which is most important? How much benefit does the combination of diet and exercise provide above and beyond either in isolation?
The outcomes of interest include children's classroom behavior, specifically time spent on and off task, behavioral cognitive skills such as accuracy and reaction time on computerized tasks assessing attention and inhibitory control, and blood flow to specific areas of the brain associated with attention and classroom behavior. This pilot study will implement a 1-week (Monday-Friday) school-based intervention using a 2 x 2 factorial design with 2 factors, morning exercise (yes/no) and breakfast (protein rich/carb rich) and 2 levels of each factor (yes or no). Children will be randomized into one of four intervention groups, 1) protein rich breakfast only, 2) exercise and carb rich breakfast, 3) both protein rich breakfast and exercise, and 4) carb rich breakfast only. Monday, Wednesday, and Friday of that week, children's classroom behavior will be monitored via a recording on a camera placed in their classroom. Friday afternoon children's cognitive function and brain blood flow will be assessed. Randomization will be conducted post baseline by a study co-investigator, Dr. Naiman Kahn using a block randomization scheme which will be applied during each wave. Waves will be in sizes that are divisible by four. Data collectors will be blind to condition. Interventions will not collect data.
The current study is a school based intervention. Children will be monitored for one week prior to intervention implementation in order to provide baseline assessments of classroom behavior, cognition, and brain blood flow. The intervention will be implemented the following week and post testing will occur during the same week on Monday, Wednesday, and Friday. Following completion of the study, all participants will be offered five days of breakfast and five days of morning exercise regardless of group assignment.
The following procedure will be followed:
Parent's will complete a demographics survey after consent to confirm the participants, age, biological sex, date of birth, race/ethnicity, household income/educational status, and any diagnosis of neuropsychological disorders such as autism spectrum disorder or Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD).
Baseline Testing: For one week prior to the intervention, children's classroom behavior will be observed three times during the week (Monday-Friday) using the Behavioral Observation of Students in Schools (BOSS) systematic observation tool. Further, baseline brain function via Functional Near Infrared Spectroscopy (fNIRS) and cognitive testing via performance on computerized tasks will be assessed at the end of the week on Friday along with height and weight.
Aerobic fitness will be assessed via a shuttle run. This test allows for a group assessment of aerobic fitness by instructing children to run in sync with a series of beeps for 20 meters. The frequency of the beeps gradually increases, requiring participants to run faster each round. Once a child cannot keep up with the pace, the test is completed. This assessment will only be completed once at baseline.
During morning physical activity sessions hart rate will be recorded using the first beat heart rate system, which includes chest straps. For the entire baseline week, children will be asked to wear an accelerometer on their hip to assess their physical activity level throughout the day. Children's height and weight will be assessed once at baseline using a scale and stadiometer.
- Conditions
- Child Development
- Being tested
- High Protein Breakfast, Morning Exercise, High Carb Breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein BreakfastBehavioural
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.
Morning ExerciseBehavioural
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.
High Carb BreakfastBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: High Carb Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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 observed intervals during which children are off-task motor during instruction (0%-100%) and a lower percentage is better.
Measured: 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)
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 observed intervals during which children are off-task verbal during instruction (0%-100%) and a lower percentage is better.
Measured: 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)
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 observed intervals during which children are off-task passive during instruction (0%-100%) and a lower percentage is better.
Measured: 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
The Fishy Flanker test requires the participant to focus on a given stimulus while inhibiting attention to stimuli flanking it. In this version of the task, younger participants see a picture of a fish flanked by two other fish on either side. On congruent trials, all the fish are pointing in the same direction. The flanker provides both an accuracy score (0%-100%) and a reaction time score in milliseconds. Higher accuracy and lower time in ms are considered better.
Measured: 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
The Go/No-go task is a simple experimental paradigm that requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behavior measured with this experiment is the participants' ability to withhold a response on No-go trials. The Go/No-Go provides both an accuracy score (0%-100%) and a reaction time score in milliseconds. Higher accuracy and lower time in ms are considered better.
Measured: 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
Brain blood flow as assessed by functional near infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is an emerging hemodynamic neuroimaging brain-computer interface (BCI) technology that indirectly measures neuronal activity in the brain's cortex via neuro-vascular coupling. The fNIRS outcomes include levels of oxyhemoglobin and deoxyhemoglobin. These measurements approximately equate to the blood-oxygen-level dependent (BOLD) signal measured in functional magnetic resonance imaging (fMRI). The results are interpreted together with the cognitive performance on task.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start3 Feb 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
- Investigators
- Eduardo Bustamante, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555627
- Sponsor's protocol ID
- 2024-0746
- Status last verified
- May 2025
- First submitted
- 29 Jul 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EMBRACE: Embracing Morning BReakfast and Activity for Classroom Engagement
- ClinicalTrials.gov ID
- NCT06555627
- Acronym / sponsor ID
- 2024-0746
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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).
Specific Aim 3: Explore potential changes in brain activity by assessing blood flow via functional near-infrared spectroscopy (fNIRS) in the prefrontal cortex, while completing the computerized cognitive tasks.
Hypothesis 3: Results are expected to evidence similar patterns as aims 1 and 2, such that blood flow in the prefrontal cortex, will increase more in groups receiving both, relative to those receiving just one, and those receiving neither. Relationships between cerebral blood flow, task performance, and classroom behavior will be assessed.
Background:
Strong experimental and observational evidence supports connections between nutrition, physical activity, and neurocognitive development. In fact, one of the first interventions to show that exercise improves cognitive abilities in elementary-aged children was conducted at the University of Illinois Urbana Champaign, and several subsequent studies have replicated these results. Many studies assessing diet quality indicate a clear link between diet quality and cognition in children. While these outcomes are important for researchers, their perceived importance to parents and teachers lies in their promise to influence academic outcomes. For example, exercise improves cognitive inhibition on lab-based tasks, but teachers want to see that the benefit generalizes to raising their hands before speaking. Here, there is surprisingly little data, limiting adoption of interventions.
Another consideration regarding health behaviors is socioeconomic status, as individuals from low income neighborhoods as well as racial/ethnic minorities have shown to have poorer dietary patterns, lower rates of physical activity, and higher rates of obesity, making children in these groups particularly vulnerable to falling behind in academic achievement and cognitive development. Thus, interventions to improve such health behaviors ought to target children representing these populations as they likely have the most gain from healthy lifestyle changes.
Finally, interventions conducted in schools are particularly advantageous as children spend most of their day in schools not only during instruction but also before and after school as childcare while parents are working. Lastly, while many observational and experimental studies show clear diet-cognition and exercise-cognition interactions, these are almost always studied in isolation without examining combined effects. Which is most important? How much benefit does the combination of diet and exercise provide above and beyond either in isolation?
The outcomes of interest include children's classroom behavior, specifically time spent on and off task, behavioral cognitive skills such as accuracy and reaction time on computerized tasks assessing attention and inhibitory control, and blood flow to specific areas of the brain associated with attention and classroom behavior. This pilot study will implement a 1-week (Monday-Friday) school-based intervention using a 2 x 2 factorial design with 2 factors, morning exercise (yes/no) and breakfast (protein rich/carb rich) and 2 levels of each factor (yes or no). Children will be randomized into one of four intervention groups, 1) protein rich breakfast only, 2) exercise and carb rich breakfast, 3) both protein rich breakfast and exercise, and 4) carb rich breakfast only. Monday, Wednesday, and Friday of that week, children's classroom behavior will be monitored via a recording on a camera placed in their classroom. Friday afternoon children's cognitive function and brain blood flow will be assessed. Randomization will be conducted post baseline by a study co-investigator, Dr. Naiman Kahn using a block randomization scheme which will be applied during each wave. Waves will be in sizes that are divisible by four. Data collectors will be blind to condition. Interventions will not collect data.
The current study is a school based intervention. Children will be monitored for one week prior to intervention implementation in order to provide baseline assessments of classroom behavior, cognition, and brain blood flow. The intervention will be implemented the following week and post testing will occur during the same week on Monday, Wednesday, and Friday. Following completion of the study, all participants will be offered five days of breakfast and five days of morning exercise regardless of group assignment.
The following procedure will be followed:
Parent's will complete a demographics survey after consent to confirm the participants, age, biological sex, date of birth, race/ethnicity, household income/educational status, and any diagnosis of neuropsychological disorders such as autism spectrum disorder or Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD).
Baseline Testing: For one week prior to the intervention, children's classroom behavior will be observed three times during the week (Monday-Friday) using the Behavioral Observation of Students in Schools (BOSS) systematic observation tool. Further, baseline brain function via Functional Near Infrared Spectroscopy (fNIRS) and cognitive testing via performance on computerized tasks will be assessed at the end of the week on Friday along with height and weight.
Aerobic fitness will be assessed via a shuttle run. This test allows for a group assessment of aerobic fitness by instructing children to run in sync with a series of beeps for 20 meters. The frequency of the beeps gradually increases, requiring participants to run faster each round. Once a child cannot keep up with the pace, the test is completed. This assessment will only be completed once at baseline.
During morning physical activity sessions hart rate will be recorded using the first beat heart rate system, which includes chest straps. For the entire baseline week, children will be asked to wear an accelerometer on their hip to assess their physical activity level throughout the day. Children's height and weight will be assessed once at baseline using a scale and stadiometer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial
| Arm | Type | Receives |
|---|---|---|
| Exercise and High Protein Breakfast | Experimental | Behavioral: High Protein Breakfast, Behavioral: Morning ExerciseChildren 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 |
| High Protein Breakfast Only | Active comparator | Behavioral: High Protein BreakfastNutrition 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 and High Carb Breakfast | Active comparator | Behavioral: Morning Exercise, Behavioral: High Carb BreakfastExercise 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. |
| High Carb Breakfast Only | Placebo comparator | Behavioral: High Carb BreakfastFor 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-11 years old
- Enrolled at the participating school
Key exclusion criteria (4 listed)
- Younger than 5 years old
- Older than 12 years old
- Not enrolled in a participating school
- Allergic to dairy or gluten
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein BreakfastFor 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. | Behavioural | Exercise and High Protein Breakfast, High Protein Breakfast Only |
| Morning ExerciseExercise 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. | Behavioural | Exercise and High Carb Breakfast, Exercise and High Protein Breakfast |
| High Carb BreakfastFor 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. | Behavioural | Exercise and High Carb Breakfast, High Carb Breakfast Only |
Primary outcome
Behavioral Observation of Students in Schools (BOSS) - Classroom Engagement (Shapiro et al., 2003)
Time frame: 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.
6 secondary outcomes
Behavioral Observation of Students in Schools (BOSS) - Off-Task Motor (Shapiro et al., 2003)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Brain blood flow as assessed by functional near infrared spectroscopy (fNIRS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bustamante principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Breakfast, Morning Exercise and High Carb Breakfast in people with Child Development, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Observation of Students in Schools (BOSS) - Classroom Engagement (Shapiro et al., 2003) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.