NCT01924130

Brief Summary

The purpose of this study is to develop and evaluate the effects of a school breakfast policy initiative (SBPI) on the incidence of overweight and obesity as well as breakfast patterns (both inside and outside of school) among 4th-6th grade children. The study integrates research, education and extension to promote healthy breakfast consumption among low-income children in urban schools and will leverage ongoing SNAP-Ed and the School Breakfast Program efforts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

July 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.9 years

First QC Date

June 28, 2013

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (4)

  • Body Mass Index

    BMI is calculated using students' height and weight measurements.

    Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

  • Breakfast Consumption habits

    Measured using a breakfast intake questionnaire.

    Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

  • Hunger

    Measured using a hunger scale questionnaire.

    Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

  • School meal participation rates

    Every month for 34 months (September 2013-June 2016)

Study Arms (2)

One Healthy Breakfast Program

EXPERIMENTAL

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

Other: Classroom feedingBehavioral: Nutrition education lessonsBehavioral: Social MarketingBehavioral: Parent outreach

Control

NO INTERVENTION

Only receive assessments.

Interventions

Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.

One Healthy Breakfast Program

Students receive breakfast specific nutrition education lessons.

One Healthy Breakfast Program

A social marketing campaign designed to promote consumption of one healthy breakfast a day. The marketing includes a healthy breakfast points-based reward program designed by the students and promotional campaigns.

One Healthy Breakfast Program
Parent outreachBEHAVIORAL

A variety of communication methods that engage families and offer education that meets their needs, including school breakfast menus, parent newsletters, and information tables at parent-teacher meetings.

One Healthy Breakfast Program

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • th-8th grade Philadelphia public school students.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

  • Polonsky HM, Bauer KW, Fisher JO, Davey A, Sherman S, Abel ML, Hanlon A, Ruth KJ, Dale LC, Foster GD. Effect of a Breakfast in the Classroom Initiative on Obesity in Urban School-aged Children: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):326-333. doi: 10.1001/jamapediatrics.2018.5531.

  • Dykstra H, Davey A, Fisher JO, Polonsky H, Sherman S, Abel ML, Dale LC, Foster GD, Bauer KW. Breakfast-Skipping and Selecting Low-Nutritional-Quality Foods for Breakfast Are Common among Low-Income Urban Children, Regardless of Food Security Status. J Nutr. 2016 Mar;146(3):630-6. doi: 10.3945/jn.115.225516. Epub 2016 Feb 10.

  • Lawman HG, Polonsky HM, Vander Veur SS, Abel ML, Sherman S, Bauer KW, Sanders T, Fisher JO, Bailey-Davis L, Ng J, Van Wye G, Foster GD. Breakfast patterns among low-income, ethnically-diverse 4th-6th grade children in an urban area. BMC Public Health. 2014 Jun 14;14:604. doi: 10.1186/1471-2458-14-604.

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Social Marketing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MarketingCommerceTechnology, Industry, and AgricultureMarketing of Health ServicesHealth Services AccessibilityDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Jennifer O Fisher, PhD

    Temple University - Center for Obesity Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

August 16, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations