Effect of the Enhanced Summer Food Service Program on Schoolchildren

Pediatric Obesity Clinical Trial

— PHAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118635
• Other study ID #: GFT640211
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: March 2017
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Intervention
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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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