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Improving High School Breakfast Environments (breakFAST!)

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ClinicalTrials.gov Identifier: NCT02004977
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Improve access to the school breakfast program Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 904 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving High School Breakfast Environments
Study Start Date : February 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Intervention arm
The role of the intervention arm (schools) is to improve access to the school breakfast program
Behavioral: 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 Name: improve access to school breakfast

No Intervention: Comparison arm
the role of the comparison arm (schools) is to maintain usual breakfast program at school



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. 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

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004977


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marilyn S Nanney, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02004977     History of Changes
Other Study ID Numbers: 1111S06384
1R01HL113235 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2013    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017