Effect of the Enhanced Summer Food Service Program on Schoolchildren

Study Overview
=================
Brief Summary
-----------------
Convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. Therefore, this project is comprised of three separate community-based interventions designed to increase access to healthy meals and physical activity opportunities to minimize excess summer weight gain in elementary school children from a diverse, low-income Rhode Island community. Specifically, we will complete a quasi-experimental study in which we will design and deliver a physical activity intervention in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a low-income, urban community. We anticipate that the addition of physical activity programming to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch meals to children during the summer in communities where at least 50% of students are eligible for free or reduced-price school meals, will increase both the acceptability and effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and 3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50 kids enrolled in the active intervention and 50 children enrolled in the control condition, both recruited from the same community.

Official Title
-----------------
Assessing the Effect of the Enhanced Summer Food Service Program on the Health of Schoolchildren

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-income (defined as qualifying for free or reduced-price meals as part of the National School Lunch Program) Ages 6-12 years Ability of child to speak, read and write English (for purposes of assessment and intervention) Parent/guardian involvement Agreement to study participation Intent to participate in the SFSP in the upcoming summer Exclusion Criteria: Medical condition that would interfere with participation in physical activity Enrolled in a camp or other physical activity based summer program.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Daily, four-hour physical activity intervention | Behavioral: Intervention<br>* Physical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily.<br>|
| No Intervention: Control<br>No treatment control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z-score over the summer | BMI was measured at the baseline visit (early June 2016) and three months later at the end of the summer (late August, 2016). Outcome of interest was change (BMIz at f/u - BMIz at baseline) | Three months (summer) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was minutes of bout-related moderate to vigorous physical activity | Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention | 
| Sedentary Behavior | Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was percent of total wear time spent sedentary (<100 counts/minute) | Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention | 
| Energy intake | Reported calorie intake from three, non-consecutive 24-hour diet recalls | Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Summer, Diet, Physical Activity, Sedentary behavior, Low-income