Viewing Study NCT04544137



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Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04544137
Status: COMPLETED
Last Update Posted: 2020-09-10
First Post: 2020-09-03

Brief Title: Summer Food Service Program
Sponsor: The Miriam Hospital
Organization: The Miriam Hospital

Study Overview

Official Title: Evaluation and Enhancement of the Summer Food Service Program in Youth From an Urban Low-resource Community
Status: COMPLETED
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This pilot trial is designed to test the acceptability and preliminary efficacy of offering the BOKS program an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily alongside the USDAs Summer Food Service Program SFSP during the summer Eighty children ages 6-12 years and from low-income households will be randomized to participate in the BOKS SFSP program or to the SFSP alone We anticipate that the BOKS program will not only provide increased physical activity for the participants but that it will help to promote participation in the SFSP given that it will be offered in the same location directly before the SFSP lunches are served
Detailed Description: Youth from low-resource communities are disproportionately affected by childhood obesity independent of race and ethnicity A time of particular vulnerability for excess weight gain in low-income youth is the summer Findings from three separate low-income populations show that BMI z-scores BMIz decrease during the school year and increase during the summer in this population To address this and aid in national obesity prevention efforts the Institute of Medicine and the White House Task Force on Childhood Obesity recommend increased access to the Summer Food Service Program SFSP a federally-funded program that provides a free healthy lunch meal to youth during the summer However participation in the SFSP is low Based on qualitative work with families from low-income communities this pilot trial is designed to test the acceptability and and preliminary efficacy of the BOKS program an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily when offered alongside the USDAs Summer Food Service Program during the summer Specifically 80 children ages 6-12 years and from low-income households will be randomized to participate in the BOKS SFSP program or to the SFSP alone To test acceptability of the combined program versus the SFSP alone we will compare SFSP participation attendance across groups Additionally we will examine physical fitness levels in both groups to determine if participation in the BOKS program prevents the loss of fitness gains achieved during the school year

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None