Improving High School Breakfast Environments (breakFAST!)

December 27, 2017 updated by: University of Minnesota

The goals of this intervention study are to implement best practice strategies to expand and promote the school breakfast program and test the impact upon student participation rates among a) all 10th and 11th grade students and among a randomly selected cohort of 800 students b) total diet and body mass index and percent body fat inin 16 rural Minnesota school districts.

School-wide Primary Aim: Improve participation in the school breakfast program among high school students. Hypothesis: School-wide school breakfast program participation will be higher in the intervention versus comparison group.

Study Overview

Status

Completed

Conditions

Detailed Description

We will accomplish the following secondary aims using a random subsample of 800 incoming 10th and11th grade students.

Student-level Secondary Aims Secondary Aim 1: High school students in the intervention condition will decrease their rate of weight gain relative to height gain as measured by change in body mass index and percent body fat compared to students in the control condition. Hypothesis: Body mass index and percent body fat will be maintained or reduced in the treatment versus control group.

Secondary Aim 2: High school students in the intervention condition will maintain or decrease their energy intake while improving dietary intakes of low fat dairy, whole grains and fresh fruits compared to the control students.

Hypothesis: Energy intake (measured by 3, 24-hour recalls) will be maintained or reduced and intakes of low fat dairy, whole grains and fresh fruits will increase more in the intervention groups.

Secondary Aim 3: Compared to students in the control condition, high school students in the intervention condition will report receiving more support to eat school breakfast. Support will be social (increased peer and school support) or related to the school environment (satisfaction with serving locations and times, eating locations, foods and increased availability of low fat dairy, fruits and whole grains for breakfast).

Hypothesis: The treatment group will report receiving more social and school environment support for eating school breakfast than the comparison group (measured by a student survey).

Study Type

Interventional

Enrollment (Actual)

904

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Must be in 10th or 11th grade in school year 2013-14 Must have access to the internet Must have access to a phone

Exclusion Criteria for the Cohort:

Unable to read English Unable to speak English Pregnant Plan to move out of the school district within school year Not in school most mornings Eat breakfast 4 or more days a week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
The role of the intervention arm (schools) is to improve access to the school breakfast program
Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
Other Names:
  • improve access to school breakfast
No Intervention: Comparison arm
the role of the comparison arm (schools) is to maintain usual breakfast program at school

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Percent Students Eating the School Breakfast Per School
Time Frame: Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
Change in participation in the reimbursable school breakfast program will be evaluated from school provided objective participation data from baseline (SY1) to the end of one school year (SY2)
Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Mass Index
Time Frame: Change from baseline (SY1) in student body mass index at the end of one school year (SY2).
Change from baseline to the end of one school year (SY2) in body mass index.
Change from baseline (SY1) in student body mass index at the end of one school year (SY2).
Change From Baseline in Percent Body Fat
Time Frame: Change from baseline in student body fat at the end of the school year (SY2)
Student percent body fat will be measured by trained research staff
Change from baseline in student body fat at the end of the school year (SY2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Healthy Eating Index Scores
Time Frame: Change from baseline in Healthy Eating Index at the end of the school year (SY2).
Change in the total Healthy Eating Index score from baseline to SY2. The Healthy Eating Index (HEI) score is a measure of diet quality. HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet
Change from baseline in Healthy Eating Index at the end of the school year (SY2).
Social Support
Time Frame: Change in perceived support from baseline at the end of the school year (SY2)
Change in social support from baseline to SY2. Assessment of social support for breakfast was measured by asking the students to consider a typical month and record how often the following people encouraged them to eat or continue to eat breakfast at school: (1) parent/guardian, (2) friend, (3) other kids at my school, (4) teacher, and (5) other school staff. A 4-point Likert-type scale (disagree to agree, 0-4) for each of the categories was used. The total scale summed the five categories. The scale ranged from 0-20, a higher score indicates more social support.
Change in perceived support from baseline at the end of the school year (SY2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marilyn S Nanney, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1111S06384
  • 1R01HL113235 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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