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School Breakfast Policy Initiative Study (SBPI)

Primary Purpose

Childhood Obesity, Hunger

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Classroom feeding
Nutrition education lessons
Social Marketing
Parent outreach
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 4th-8th grade Philadelphia public school students.

Exclusion Criteria:

-

Sites / Locations

  • Temple University - Center for Obesity Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

One Healthy Breakfast Program

Control

Arm Description

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

Only receive assessments.

Outcomes

Primary Outcome Measures

Body Mass Index
BMI is calculated using students' height and weight measurements.
Breakfast Consumption habits
Measured using a breakfast intake questionnaire.
Hunger
Measured using a hunger scale questionnaire.
School meal participation rates

Secondary Outcome Measures

Full Information

First Posted
June 28, 2013
Last Updated
August 29, 2016
Sponsor
Temple University
Collaborators
The Food Trust, The School District of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01924130
Brief Title
School Breakfast Policy Initiative Study
Acronym
SBPI
Official Title
Increasing Breakfast Consumption and Decreasing Childhood Obesity Among Low-income, Ethnically Diverse Youth.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
The Food Trust, The School District of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Policy makers have promoted school breakfast participation as a tool to help prevent childhood obesity. No randomized controlled trials have examined the effects of a school breakfast feeding program on obesity. We propose to develop and evaluate a School Breakfast Policy Initiative (SBPI) that combines classroom feeding, in-school nutrition education, social marketing and parent outreach. Specifically, we will promote the benefits of a healthy breakfast at school or home and deter buying "breakfast" at corner stores where purchases are high in energy, solid fats and added sugars. This intervention will be evaluated in the "real world" of urban schools that make frequent use of the SNAP-Ed and the School Breakfast Program. The specific aims are: To develop the SBPI intervention within the context of SNAP Ed and the National School Breakfast Program in the School District of Philadelphia. To conduct a pilot feasibility study among 4 schools (2 intervention and 2 control) to assess feasibility and acceptability. To compare participants in the intervention (n=8) and comparison schools (n=8) on the incidence of overweight and obesity. We predict that intervention schools, compared to the comparison schools, will have a significantly lower incidence rate of overweight and obesity over a 2 y period. To compare participants in the intervention (n=8) and comparison schools (n=8) on eating one breakfast. We predict that intervention schools, compared to the comparison schools, will have significantly greater percentage of children eating one breakfast per day over a 2 y period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Hunger

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One Healthy Breakfast Program
Arm Type
Experimental
Arm Description
Classroom feeding, nutrition education lessons, social marketing, and parent outreach.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only receive assessments.
Intervention Type
Other
Intervention Name(s)
Classroom feeding
Intervention Description
Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education lessons
Intervention Description
Students receive breakfast specific nutrition education lessons.
Intervention Type
Behavioral
Intervention Name(s)
Social Marketing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent outreach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
BMI is calculated using students' height and weight measurements.
Time Frame
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)
Title
Breakfast Consumption habits
Description
Measured using a breakfast intake questionnaire.
Time Frame
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)
Title
Hunger
Description
Measured using a hunger scale questionnaire.
Time Frame
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)
Title
School meal participation rates
Time Frame
Every month for 34 months (September 2013-June 2016)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 4th-8th grade Philadelphia public school students. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer O Fisher, PhD
Organizational Affiliation
Temple University - Center for Obesity Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University - Center for Obesity Research and Education
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30801612
Citation
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. Erratum In: JAMA Pediatr. 2019 May 28;:
Results Reference
derived
PubMed Identifier
26865650
Citation
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.
Results Reference
derived
PubMed Identifier
24928474
Citation
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.
Results Reference
derived

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School Breakfast Policy Initiative Study

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