NCT03536676

Brief Summary

This study will test whether whether the implementation of and Egg-cellent 'Breakfast in the Classroom' improves school breakfast participation and breakfast consumption in middle school adolescents; whether the implementation of 'Breakfast in the Classroom' improves appetite control, mood, cognitive performance, and unhealthy snacking behavior in middle school adolescents when compared to a traditional school breakfast program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration 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

Study Start

First participant enrolled

April 24, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

May 2, 2018

Last Update Submit

January 5, 2022

Conditions

BreakfastObesityMoodEating Behavior

Keywords

BreakfastObesityMoodEating BehaviorCognitive Function

Outcome Measures

Primary Outcomes (1)

  • School Breakfast Program Participation

    Participation at during the traditional school breakfast program and throughout the Breakfast in the Classroom program will be determined by the electronic school meal tracking system that logs student participation each day for breakfast and lunch.

    3-weeks prior to program initiation and 3-weeks of program

Secondary Outcomes (7)

  • Habitual Breakfast Habits Questionnaire

    Baseline and 3-weeks after beginning the intervention

  • Benefits of Breakfast Questionnaire

    Baseline and 3-weeks after beginning the intervention

  • Snacking Questionnaires

    Baseline and 3-weeks after beginning the intervention

  • Cognitive Performance Assessment

    Baseline and 3-weeks after beginning the intervention

  • Appetite Questionnaires

    Baseline and 3-weeks after beginning the intervention

  • +2 more secondary outcomes

Study Arms (2)

Traditional School Breakfast Program

ACTIVE COMPARATOR

The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8.

Other: Breakfast in the Classroom

'Egg-Cellent' Breakfast in the Classroom

EXPERIMENTAL

The breakfasts for the 3-week program will adhere to the United States Department of Agriculture nutrition requirements for Grades 6-8 but will include an additional 2 large eggs/breakfast.

Other: 'Egg-cellent' Breakfast in the Classroom

Interventions

'Egg-cellent' Breakfast in the ClassroomOTHER

Includes the additional 2 eggs per day

'Egg-Cellent' Breakfast in the Classroom
Breakfast in the ClassroomOTHER

Receives the standard meal for Breakfast in the Classroom

Traditional School Breakfast Program

Eligibility Criteria

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

You may qualify if:

  • All students from the Center Middle School in Kansas City, MO who choose to participate and whose parent/legal guardian (excluding Wards of the State) signs the consent will be included.

You may not qualify if:

  • Wards of the State will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center Middle School

Kansas City, Missouri, 64114, United States

Location

MeSH Terms

Conditions

ObesityFeeding Behavior

Interventions

Breakfast

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Heather Leidy, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 25, 2018

Study Start

April 24, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)