Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom

Study Overview
=================
Brief Summary
-----------------
This study will test whether whether the implementation of and Egg-cellent 'Breakfast in the Classroom' improves school breakfast participation and breakfast consumption in middle school adolescents; whether the implementation of 'Breakfast in the Classroom' improves appetite control, mood, cognitive performance, and unhealthy snacking behavior in middle school adolescents when compared to a traditional school breakfast program.

Detailed Description
-----------------
The investigators propose an 4-week cross-over design breakfast study in children enrolled in 6-8th grade within the Center School District in the Kansas City, Missouri. This school will begin their 'Breakfast in the Classroom' program on March 26, 2018. Prior to the start of 'Breakfast in the Classroom', baseline data will be collected on the students who wish to participate in the study. Baseline data includes anthropometric assessments; demographics; current eating habits; cognitive performance; appetite; and mood. Following baseline, the students will be provided a breakfast that meets all the requirements for a reimbursable school breakfast with the addition of two eggs for 3-weeks: At 4 weeks (3 weeks after initiation of the program), the study participants will complete a similar outcomes to those completed at baseline.

Official Title
-----------------
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom

Conditions
-----------------
Breakfast, Obesity, Mood, Eating Behavior

Intervention / Treatment
-----------------
* Other: 'Egg-cellent' Breakfast in the Classroom
* Other: Breakfast in the Classroom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students from the Center Middle School in Kansas City, MO who choose to participate and whose parent/legal guardian (excluding Wards of the State) signs the consent will be included. Exclusion Criteria: Wards of the State will be excluded from this study.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional School Breakfast Program<br>The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8. | Other: Breakfast in the Classroom<br>* Receives the standard meal for Breakfast in the Classroom<br>|
| Experimental: 'Egg-Cellent' Breakfast in the Classroom<br>The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8 but will include an additional 2 large eggs/breakfast. | Other: 'Egg-cellent' Breakfast in the Classroom<br>* Includes the additional 2 eggs per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School Breakfast Program Participation | Participation at during the traditional school breakfast program and throughout the Breakfast in the Classroom program will be determined by the electronic school meal tracking system that logs student participation each day for breakfast and lunch. | 3-weeks prior to program initiation and 3-weeks of program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Habitual Breakfast Habits Questionnaire | During one day, a questionnaire assessing previous breakfast habits will be given to participants. This questionnaire asks how many days per week they consume various breakfast foods. | Baseline and 3-weeks after beginning the intervention | 
| Benefits of Breakfast Questionnaire | During one day, a questionnaire asking the participants what happens when participants consume breakfast and skip breakfast will be administered. They will be given a list of choices (multiple selections are allowed) and the units for analysis will be binary (they chose it or did not choose it). | Baseline and 3-weeks after beginning the intervention | 
| Snacking Questionnaires | During one day, questionnaires assessing typical snacking behavior will be completed once. Participants will be asked to think about what they ate during the past week. They will be asked how many times they ate a variety of foods throughout this week. The students will complete these on their respective Chromebook laptops or will be provided paper copies (if their Chromebook is not available). | Baseline and 3-weeks after beginning the intervention | 
| Cognitive Performance Assessment | During one day, cognitive performance assessments will occur once between 120 min and 180 min after breakfast using the online CNS Vital Signs neurocognitive assessment system during one day. The CNS Vital Signs system contains a battery of computerized tests to assess attention, memory, executive function, and cognitive flexibility. The assessment will occur outside of classroom learning activities. | Baseline and 3-weeks after beginning the intervention | 
| Appetite Questionnaires | Questionnaires, assessing hunger, fullness, prospective food consumption, and eating initiation, will be completed during the following times for 1 day immediately before lunch. The questions are worded as how strong is your feeling of or how strong is your desire with anchors of not at all to extremely. The students will complete these on their respective Chromebook laptops or will be provided paper copies (if their Chromebook is not available). All results will be a number from 0 (not at all) to 100 (extremely) with the unit of out of 100. | Baseline and 3-weeks after beginning the intervention | 
| Mood State Questionnaires | Questionnaires assessing tiredness, sleepiness, energy, irritability/agitation, etc.) will be completed during the following times for 1 day immediately before lunch. The questions are worded as how strong is your feeling of or how strong is your desire with anchors of not at all to extremely. The students will complete these on their respective Chromebook laptops or will be provided paper copies (if their Chromebook is not available). All results will be a number from 0 (not at all) to 100 (extremely) with the unit of out of 100. | Baseline and 3-weeks (Post-study) | 
| Breakfast in the Classroom Participation Questionnaire | Questionnaires assessing whether they ate breakfast or skipped breakfast and what types of foods they ate (if they ate breakfast) will be completed for 5 consecutive days during baseline. | Baseline and 3-weeks after beginning the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breakfast, Obesity, Mood, Eating Behavior, Cognitive Function