Purdue Study for the Benefits of Breakfast in the Classroom

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 Overview

• Status: Completed
• Conditions: Breakfast
• Intervention / Treatment: Other: Breakfast in the Classroom

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center Middle School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Wards of the State

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Breakfast in the Classroom; 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.

Other: Breakfast in the Classroom; For all breakfasts, the students will use the 'grab and go' approach from hallway kiosks. The students will take the breakfasts back to their respective classroom and consume them there.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breakfast in the Classroom Participation Questionnaire	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).	change from baseline at 8-weeks, 16 weeks, and 24-weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habitual Breakfast Habits Questionnaire - At School	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. There are 17 breakfast options, and they will report how many times per week they have consumed them over the past month. The options include never, 1-2 times per week, 3-4 times per week, or every school day.	change from baseline at 8-weeks, 16 weeks, and 24-weeks.
Habitual Breakfast Habits Questionnaire - At Home	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. There are 17 breakfast options, and they will report how many times per week they have consumed them over the past month. The options include never, 1-2 times per week, 3-4 times per week, 5-6 times per week, or every day.	change from baseline at 8-weeks, 16 weeks, and 24-weeks.
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).	change from baseline at 8-weeks, 16 weeks, and 24-weeks.
Snacking Questionnaires	During one day, questionnaires assessing typical snacking behavior will be completed once. Participants will be asked how many times they ate 18 specific foods/food groups throughout the past week. The options include none, 1 total, 2-4 total, 5-6 total, 1 each day, 2-3 each day, or 4+ each day. The students will complete these on their respective Chromebook laptops or will be provided paper copies (if their Chromebook is not available).	change from baseline at 8-weeks, 16 weeks, and 24-weeks.
Cognitive Performance Assessment	During one day, cognitive performance assessments will occur once prior to lunch and 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.	8-weeks, 16 weeks, and 24-weeks post intervention
Hunger Questionnaires	Questionnaires assessing hunger will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, and 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Fullness Questionnaires	Questionnaires assessing fullness will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, and 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Prospective Food Consumption Questionnaires	Questionnaires assessing prospective food consumption will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, and 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Energy Questionnaires	Questionnaires assessing energy will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Sleepiness Questionnaires	Questionnaires assessing sleepiness will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Happiness Questionnaires	Questionnaires assessing happiness will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Stress Questionnaires	Questionnaires assessing stress levels will be completed during the following times for 3 consecutive days: before breakfast, immediately after breakfast, 60 minutes after breakfast, 120 minutes after breakfast, 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."	8-weeks, 16 weeks, and 24-weeks post intervention
Breakfast Plate Waste	For 5 days, the students will be asked to place all uneaten breakfasts into labeled baggies and discard in the bins at the front of the room. Research staff will weigh the meals prior to being delivered to the hallway kiosks and will re-weight the meals once the students are finished with breakfast.	8-weeks, 16 weeks, and 24-weeks post intervention
Body Mass Index Change	Body mass index (units of kg/m^2) will be calculated based on body weight and height of participants. Body weight will be measured to the nearest tenth of a kg using a standard scale. Height will be assessed with a stadiometer or wall ruler (to the nearest tenth of a centimeter). Both procedures will be measured in a private room.	change from baseline at 8-weeks, 16 weeks, and 24-weeks.

Collaborators and Investigators

• Sponsor: Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1807020818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No