Clinical trial NCT02004977: Improving High School Breakfast Environments
Official title: Improving High School Breakfast Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-12-09
Enrollment: 904
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Percent Students Eating the School Breakfast Per School
timeFrame: Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
Secondary outcomes:
measure: Change From Baseline in Body Mass Index
timeFrame: Change from baseline (SY1) in student body mass index at the end of one school year (SY2).
measure: Change From Baseline in Percent Body Fat
timeFrame: Change from baseline in student body fat at the end of the school year (SY2)
Other outcomes:
measure: Change From Baseline in Healthy Eating Index Scores
timeFrame: Change from baseline in Healthy Eating Index at the end of the school year (SY2).
measure: Social Support
timeFrame: Change in perceived support from baseline at the end of the school year (SY2)
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Marilyn S Nanney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nanney MS, Leduc R, Hearst M, Shanafelt A, Wang Q, Schroeder M, Grannon KY, Kubik MY, Caspi C, Harnack LJ. A Group Randomized Intervention Trial Increases Participation in the School Breakfast Program in 16 Rural High Schools in Minnesota. J Acad Nutr Diet. 2019 Jun;119(6):915-922. doi: 10.1016/j.jand.2018.12.007. Epub 2019 Feb 14.