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Clinical Trials/NCT03637010
NCT03637010CompletedNot Applicable

Purdue Study for the Benefits of Breakfast in the Classroom

Purdue University2 sites in 1 country330 target enrollmentStarted: August 20, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
330
Locations
2
Primary Endpoint
Breakfast in the Classroom Participation Questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
10 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Wards of the State

Outcomes

Primary Outcomes

Breakfast in the Classroom Participation Questionnaire

Time Frame: change from baseline at 8-weeks, 16 weeks, and 24-weeks.

Questionnaires assessing whether they ate breakfast or skipped breakfast will be completed for 5 consecutive days. There are two options: yes (they did consume breakfast prior to arriving at school) or no (did not consume breakfast prior to arriving at school).

Secondary Outcomes

  • Habitual Breakfast Habits Questionnaire - At Home(change from baseline at 8-weeks, 16 weeks, and 24-weeks.)
  • Snacking Questionnaires(change from baseline at 8-weeks, 16 weeks, and 24-weeks.)
  • Fullness Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Stress Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Benefits of Breakfast Questionnaire(change from baseline at 8-weeks, 16 weeks, and 24-weeks.)
  • Hunger Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Cognitive Performance Assessment(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Prospective Food Consumption Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Happiness Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Habitual Breakfast Habits Questionnaire - At School(change from baseline at 8-weeks, 16 weeks, and 24-weeks.)
  • Energy Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Sleepiness Questionnaires(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Breakfast Plate Waste(8-weeks, 16 weeks, and 24-weeks post intervention)
  • Body Mass Index Change(change from baseline at 8-weeks, 16 weeks, and 24-weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heather Leidy

Associate Professor, Nutrition Sciences

Purdue University

Study Sites (2)

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