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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Summer, Diet, Physical Activity, Sedentary behavior, Low-income

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Daily, four-hour physical activity intervention

No treatment control

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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)
Energy intake
Reported calorie intake from three, non-consecutive 24-hour diet recalls

Full Information

First Posted
April 4, 2017
Last Updated
September 3, 2019
Sponsor
The Miriam Hospital
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT03118635
Brief Title
Effect of the Enhanced Summer Food Service Program on Schoolchildren
Acronym
PHAST
Official Title
Assessing the Effect of the Enhanced Summer Food Service Program on the Health of Schoolchildren
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Summer, Diet, Physical Activity, Sedentary behavior, Low-income

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Daily, four-hour physical activity intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment control
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMI z-score over the summer
Description
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)
Time Frame
Three months (summer)
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was minutes of bout-related moderate to vigorous physical activity
Time Frame
Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Title
Sedentary Behavior
Description
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)
Time Frame
Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Title
Energy intake
Description
Reported calorie intake from three, non-consecutive 24-hour diet recalls
Time Frame
Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29868357
Citation
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.
Results Reference
derived

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Effect of the Enhanced Summer Food Service Program on Schoolchildren

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