NCT03637010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

August 13, 2018

Last Update Submit

January 5, 2022

Conditions

Breakfast

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Habitual Breakfast Habits Questionnaire - At School

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

  • Habitual Breakfast Habits Questionnaire - At Home

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

  • Benefits of Breakfast Questionnaire

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

  • Snacking Questionnaires

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

  • Cognitive Performance Assessment

    8-weeks, 16 weeks, and 24-weeks post intervention

  • +9 more secondary outcomes

Study Arms (1)

Breakfast in the Classroom

OTHER

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

Interventions

Breakfast in the ClassroomOTHER

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.

Breakfast in the Classroom

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Wards of the State

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center Middle School

Kansas City, Missouri, 64114, United States

Location

MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Nutrition Sciences

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 17, 2018

Study Start

August 20, 2018

Primary Completion

March 14, 2019

Study Completion

June 1, 2019

Last Updated

January 10, 2022

Record last verified: 2022-01

Locations

US(1)