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

Primary Purpose

Breakfast, Obesity, Mood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
'Egg-cellent' Breakfast in the Classroom
Breakfast in the Classroom
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breakfast focused on measuring Breakfast, Obesity, Mood, Eating Behavior, Cognitive Function

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center Middle School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional School Breakfast Program

'Egg-Cellent' Breakfast in the Classroom

Arm Description

The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
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.
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."
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."
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.

Full Information

First Posted
May 2, 2018
Last Updated
January 5, 2022
Sponsor
Purdue University
Collaborators
Egg Nutrition Center
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1. Study Identification

Unique Protocol Identification Number
NCT03536676
Brief Title
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
Official Title
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Egg Nutrition Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakfast, Obesity, Mood, Eating Behavior
Keywords
Breakfast, Obesity, Mood, Eating Behavior, Cognitive Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional School Breakfast Program
Arm Type
Active Comparator
Arm Description
The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8.
Arm Title
'Egg-Cellent' Breakfast in the Classroom
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
'Egg-cellent' Breakfast in the Classroom
Intervention Description
Includes the additional 2 eggs per day
Intervention Type
Other
Intervention Name(s)
Breakfast in the Classroom
Intervention Description
Receives the standard meal for Breakfast in the Classroom
Primary Outcome Measure Information:
Title
School Breakfast Program Participation
Description
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.
Time Frame
3-weeks prior to program initiation and 3-weeks of program
Secondary Outcome Measure Information:
Title
Habitual Breakfast Habits Questionnaire
Description
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.
Time Frame
Baseline and 3-weeks after beginning the intervention
Title
Benefits of Breakfast Questionnaire
Description
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).
Time Frame
Baseline and 3-weeks after beginning the intervention
Title
Snacking Questionnaires
Description
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).
Time Frame
Baseline and 3-weeks after beginning the intervention
Title
Cognitive Performance Assessment
Description
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.
Time Frame
Baseline and 3-weeks after beginning the intervention
Title
Appetite Questionnaires
Description
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."
Time Frame
Baseline and 3-weeks after beginning the intervention
Title
Mood State Questionnaires
Description
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."
Time Frame
Baseline and 3-weeks (Post-study)
Title
Breakfast in the Classroom Participation Questionnaire
Description
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.
Time Frame
Baseline and 3-weeks after beginning the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Leidy, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Middle School
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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