Purdue Study for the Benefits of Breakfast in the Classroom

Breakfast Clinical Trial

Official title:

Purdue Study for the Benefits of Breakfast in the Classroom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637010
• Other study ID #: 1807020818
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 1, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Wards of the State

Related Conditions & MeSH terms

• Breakfast

Intervention

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.

Locations

Country	Name	City	State
United States	Center Middle School	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.