Clinical trial NCT03637010: Purdue Study for the Benefits of Breakfast in the Classroom
Official title: Purdue Study for the Benefits of Breakfast in the Classroom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breakfast
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 330
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is a 24-week crossover design study in adolescents enrolled in the 6-8th grade within the Center School District in the Kansas City, MO. This school will begin their 'Breakfast in the Classroom' program during the fall 2018 school year. Baseline data will be collected to include anthropometric measures, participant characteristics, and past eating habits. For the first 8 weeks, the students will be provided with breakfast meals containing the USDA nutrition requirements. These meals are typically higher in carbohydrates and lower in protein. For the second 8 weeks, the students will be provided with higher-protein breakfast meals. These meals also contain the USDA nutrition requirements but include high-quality protein-rich foods. For the remaining 8 weeks, the students will be provided both types of meals and will be permitted to choose which they prefer to consume each day. At the end of each 8-week period, eating habits, appetite, mood, cognitive performance, and anthropometrics will be completed along with measurements of breakfast waste.


Eligibility criteria: Inclusion Criteria:

* All students who are willing to participate are eligible (except Wards of the State)

Exclusion Criteria:

* Wards of the State

Primary outcomes:
measure: Breakfast in the Classroom Participation Questionnaire
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
Secondary outcomes:
measure: Habitual Breakfast Habits Questionnaire - At School
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
measure: Habitual Breakfast Habits Questionnaire - At Home
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
measure: Benefits of Breakfast Questionnaire
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
measure: Snacking Questionnaires
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
measure: Cognitive Performance Assessment
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Hunger Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Fullness Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Prospective Food Consumption Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Energy Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Sleepiness Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Happiness Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Stress Questionnaires
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Breakfast Plate Waste
timeFrame: 8-weeks, 16 weeks, and 24-weeks post intervention
measure: Body Mass Index Change
timeFrame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Center Middle School
state: Missouri
Study officials:
References: