School Breakfast Policy Initiative Study

Study Overview
=================
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.

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

Conditions
-----------------
Hunger, Childhood Obesity

Intervention / Treatment
-----------------
* Other: Classroom feeding
* Behavioral: Nutrition education lessons
* Behavioral: Social Marketing
* Behavioral: Parent outreach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4th-8th grade Philadelphia public school students. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Healthy Breakfast Program<br>Classroom feeding, nutrition education lessons, social marketing, and parent outreach. | Other: Classroom feeding<br>* Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.<br>Behavioral: Nutrition education lessons<br>* Students receive breakfast specific nutrition education lessons.<br>Behavioral: Social Marketing<br>* 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.<br>Behavioral: Parent outreach<br>* 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.<br>|
| No Intervention: Control<br>Only receive assessments. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |