- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536676
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
January 5, 2022 updated by: Heather Leidy, Purdue University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64114
- Center Middle School
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional School Breakfast Program
The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8.
|
Receives the standard meal for Breakfast in the Classroom
|
Experimental: 'Egg-Cellent' Breakfast in the Classroom
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.
|
Includes the additional 2 eggs per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
School Breakfast Program Participation
Time Frame: 3-weeks prior to program initiation and 3-weeks of program
|
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
Time Frame: Baseline and 3-weeks after beginning the intervention
|
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
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Benefits of Breakfast Questionnaire
Time Frame: Baseline and 3-weeks after beginning the intervention
|
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
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Snacking Questionnaires
Time Frame: Baseline and 3-weeks after beginning the intervention
|
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
Time Frame: Baseline and 3-weeks after beginning the intervention
|
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
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Appetite Questionnaires
Time Frame: Baseline and 3-weeks after beginning the intervention
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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."
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Baseline and 3-weeks after beginning the intervention
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Mood State Questionnaires
Time Frame: Baseline and 3-weeks (Post-study)
|
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)
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Breakfast in the Classroom Participation Questionnaire
Time Frame: Baseline and 3-weeks after beginning the intervention
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather Leidy, PhD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2018
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (Actual)
May 25, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17120035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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