Overview

This trial is active, not recruiting.

Condition obesity
Treatment improve access to the school breakfast program
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date February 2013
End date February 2017
Trial size 800 participants
Trial identifier NCT02004977, 1111S06384, 1R01HL113235

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The role of the intervention arm (schools) is to improve access to the school breakfast program
improve access to the school breakfast program improve access to school breakfast
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.
(No Intervention)
the role of the comparison arm (schools) is to maintain usual breakfast program at school

Primary Outcomes

Measure
Percent students eating the school breakfast
time frame: Change from baseline in student level breakfast participation at the end of one school year and two school years

Secondary Outcomes

Measure
Objectively measured student height and weight
time frame: Change from baseline in student body mass index at the end of one school year and two school years
Percent body fat
time frame: Change from baseline in student body fat at the end of the school year

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Improving High School Breakfast Environments
Principal investigator Marilyn S Nanney, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.