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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118635
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
The Miriam Hospital

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

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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

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



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118635


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Brown University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03118635    
Other Study ID Numbers: GFT640211
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight