Purdue Study for the Benefits of Breakfast in the Classroom

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.

Official Title
-----------------
Purdue Study for the Benefits of Breakfast in the Classroom

Conditions
-----------------
Breakfast

Intervention / Treatment
-----------------
* Other: Breakfast in the Classroom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students who are willing to participate are eligible (except Wards of the State) Exclusion Criteria: Wards of the State

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breakfast in the Classroom<br>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<br>* 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.<br>|

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. |