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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536676
• Other study ID #: 17120035
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breakfast
• Eating Behavior
• Mood
• Obesity

Intervention

Other:
• 'Egg-cellent' Breakfast in the Classroom
Includes the additional 2 eggs per day
• Breakfast in the Classroom
Receives the standard meal for Breakfast in the Classroom

Locations

Country	Name	City	State
United States	Center Middle School	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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