Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555627
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Embracing Morning BReakfast and Activity for Classroom Engagement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Project EMBRACE Embracing Morning BReakfast and Activity for Classroom Engagement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This experiment will test the effects of healthy breakfast and morning exercise on childrens 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 racialethnic 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 childrens 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 yesno and breakfast protein richcarb 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 childrens classroom behavior will be monitored via a recording on a camera placed in their classroom Friday afternoon childrens 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
Parents will complete a demographics survey after consent to confirm the participants age biological sex date of birth raceethnicity household incomeeducational status and any diagnosis of neuropsychological disorders such as autism spectrum disorder or Attention-Deficit HyperactivityImpulsivity Disorder ADHD
Baseline Testing For one week prior to the intervention childrens 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 Childrens height and weight will be assessed once at baseline using a scale and stadiometer
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 racialethnic 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 childrens 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 yesno and breakfast protein richcarb 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 childrens classroom behavior will be monitored via a recording on a camera placed in their classroom Friday afternoon childrens 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
Parents will complete a demographics survey after consent to confirm the participants age biological sex date of birth raceethnicity household incomeeducational status and any diagnosis of neuropsychological disorders such as autism spectrum disorder or Attention-Deficit HyperactivityImpulsivity Disorder ADHD
Baseline Testing For one week prior to the intervention childrens 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 Childrens height and weight will be assessed once at baseline using a scale and stadiometer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None