BreakfastNCT03536676
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
A study testing 'Egg-cellent' Breakfast in the Classroom and Breakfast in the Classroom in people with Breakfast and Obesity, run by Purdue University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- What is being tested?
- 'Egg-cellent' Breakfast in the Classroom and Breakfast in the Classroom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Wards of the State will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breakfast, Obesity, Mood, Eating Behavior
- Being tested
- 'Egg-cellent' Breakfast in the Classroom, Breakfast in the Classroom
- Keywords
- Breakfast, Obesity, Mood, Eating Behavior, Cognitive Function
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Egg-cellent' Breakfast in the ClassroomOther
Includes the additional 2 eggs per day
Breakfast in the ClassroomOther
Receives the standard meal for Breakfast in the Classroom
| Study group | Role | What they receive |
|---|---|---|
| Traditional School Breakfast Program | Active comparator | The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8. Receives: Other: Breakfast in the Classroom |
| 'Egg-Cellent' Breakfast in the Classroom | Experimental | 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. Receives: Other: 'Egg-cellent' Breakfast in the Classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-weeks prior to program initiation and 3-weeks of program
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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.
Measured: Baseline and 3-weeks after beginning the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start24 Apr 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreakfastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
- Investigators
- Heather Leidy, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536676
- Sponsor's protocol ID
- 17120035
- Status last verified
- Jan 2022
- First submitted
- 2 May 2018
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom
- ClinicalTrials.gov ID
- NCT03536676
- Acronym / sponsor ID
- 17120035
- Conditions
- Breakfast, Obesity, Mood, Eating Behavior
- Keywords
- Breakfast, Obesity, Mood, Eating Behavior, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional School Breakfast Program | Active comparator | Other: Breakfast in the ClassroomThe breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8. |
| 'Egg-Cellent' Breakfast in the Classroom | Experimental | Other: 'Egg-cellent' Breakfast in the ClassroomThe 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Wards of the State will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Egg-cellent' Breakfast in the ClassroomIncludes the additional 2 eggs per day | Other | 'Egg-Cellent' Breakfast in the Classroom |
| Breakfast in the ClassroomReceives the standard meal for Breakfast in the Classroom | Other | Traditional School Breakfast Program |
Primary outcome
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.
7 secondary outcomes
Habitual Breakfast Habits Questionnaire
Time frame: Baseline and 3-weeks after beginning the intervention
Benefits of Breakfast Questionnaire
Time frame: Baseline and 3-weeks after beginning the intervention
Snacking Questionnaires
Time frame: Baseline and 3-weeks after beginning the intervention
Cognitive Performance Assessment
Time frame: Baseline and 3-weeks after beginning the intervention
Appetite Questionnaires
Time frame: Baseline and 3-weeks after beginning the intervention
Mood State Questionnaires
Time frame: Baseline and 3-weeks (Post-study)
Breakfast in the Classroom Participation Questionnaire
Time frame: Baseline and 3-weeks after beginning the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Leidy, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Egg-cellent' Breakfast in the Classroom and Breakfast in the Classroom in people with Breakfast and Obesity, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Breakfast Program Participation (time frame: 3-weeks prior to program initiation and 3-weeks of program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.