School Breakfast Policy Initiative Study

Childhood Obesity Clinical Trial

— SBPI  

Official title:

Increasing Breakfast Consumption and Decreasing Childhood Obesity Among Low-income, Ethnically Diverse Youth.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924130
• Other study ID #: 20452
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: August 29, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: School District of Philadelphia Office of Research and Evaluation
• Study type: Interventional

Clinical Trial 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.

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:

1. To develop the SBPI intervention within the context of SNAP Ed and the National School Breakfast Program in the School District of Philadelphia.

2. To conduct a pilot feasibility study among 4 schools (2 intervention and 2 control) to assess feasibility and acceptability.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Hunger
• Obesity
• Pediatric Obesity

Intervention

Other:
• Classroom feeding
Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.

Behavioral:
• Nutrition education lessons
Students receive breakfast specific nutrition education lessons.
• Social Marketing
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.
• Parent outreach
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.

Locations

Country	Name	City	State
United States	Temple University - Center for Obesity Research and Education	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	The Food Trust, The School District of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	School meal participation rates		Every month for 34 months (September 2013-June 2016)	No