Effect of the Enhanced Summer Food Service Program on Schoolchildren (PHAST)

• ClinicalTrials.gov Identifier: NCT03118635
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: September 4, 2019
• Sponsor: The Miriam Hospital
• Collaborator: Brown University
• Information provided by (Responsible Party): The Miriam Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Obesity	Behavioral: Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessing the Effect of the Enhanced Summer Food Service Program on the Health of Schoolchildren
• Actual Study Start Date: June 15, 2016
• Actual Primary Completion Date: September 1, 2016
• Actual Study Completion Date: September 1, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Daily, four-hour physical activity 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.
No Intervention: Control; No treatment control

Outcome Measures

Primary Outcome Measures :

1. Change in BMI z-score over the summer [ Time Frame: Three months (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)

Secondary Outcome Measures :

1. Physical Activity [ Time Frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention ]
   Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was minutes of bout-related moderate to vigorous physical activity
2. Sedentary Behavior [ Time Frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention ]
   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)
3. Energy intake [ Time Frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention ]
   Reported calorie intake from three, non-consecutive 24-hour diet recalls

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Rhode Island

The Miriam Hospital

Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

The Miriam Hospital

Brown University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Evans EW, Bond DS, Pierre DF, Howie WC, Wing RR, Jelalian E. Promoting health and activity in the summer trial: Implementation and outcomes of a pilot study. Prev Med Rep. 2018 Feb 16;10:87-92. doi: 10.1016/j.pmedr.2018.02.008. eCollection 2018 Jun.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT03118635
• Other Study ID Numbers: GFT640211
• First Posted: April 18, 2017
• Last Update Posted: September 4, 2019
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Miriam Hospital:

Summer; Diet; Physical Activity; Sedentary behavior; Low-income

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight