NCT02004977

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
904

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

November 12, 2013

Results QC Date

November 17, 2017

Last Update Submit

December 27, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Percent Students Eating the School Breakfast Per School

    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 Outcomes (2)

  • Change From Baseline 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

    Change from baseline in student body fat at the end of the school year (SY2)

Other Outcomes (2)

  • Change From Baseline in Healthy Eating Index Scores

    Change from baseline in Healthy Eating Index at the end of the school year (SY2).

  • Social Support

    Change in perceived support from baseline at the end of the school year (SY2)

Study Arms (2)

Intervention arm

EXPERIMENTAL

The role of the intervention arm (schools) is to improve access to the school breakfast program

Behavioral: Improve access to the school breakfast program

Comparison arm

NO INTERVENTION

the role of the comparison arm (schools) is to maintain usual breakfast program at school

Interventions

Improve access to the school breakfast programBEHAVIORAL

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.

Also known as: improve access to school breakfast
Intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

  • 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.

    PMID: 30772298DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Susie Nanney
Organization
University of Minnesota
msnanney@umn.edu
612-626-6794

Study Officials

  • Marilyn S Nanney, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

December 9, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 23, 2018

Results First Posted

January 23, 2018

Record last verified: 2017-12

Locations

US(1)