Clinical trial NCT03536676: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breakfast
Obesity
Mood
Eating Behavior
Keywords: Breakfast
Obesity
Mood
Eating Behavior
Cognitive Function
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2018-05-25
Enrollment: 91
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: School Breakfast Program Participation
timeFrame: 3-weeks prior to program initiation and 3-weeks of program
Secondary outcomes:
measure: Habitual Breakfast Habits Questionnaire
timeFrame: Baseline and 3-weeks after beginning the intervention
measure: Benefits of Breakfast Questionnaire
timeFrame: Baseline and 3-weeks after beginning the intervention
measure: Snacking Questionnaires
timeFrame: Baseline and 3-weeks after beginning the intervention
measure: Cognitive Performance Assessment
timeFrame: Baseline and 3-weeks after beginning the intervention
measure: Appetite Questionnaires
timeFrame: Baseline and 3-weeks after beginning the intervention
measure: Mood State Questionnaires
timeFrame: Baseline and 3-weeks (Post-study)
measure: Breakfast in the Classroom Participation Questionnaire
timeFrame: Baseline and 3-weeks after beginning the intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Center Middle School
state: Missouri
Study officials:
affiliation: Associate Professor
name: Heather Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
References: