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Clinical Trials/NCT04544137
NCT04544137CompletedNot Applicable

Evaluation and Enhancement of the Summer Food Service Program in Youth From an Urban, Low-resource Community

The Miriam Hospital2 sites in 1 country43 target enrollmentStarted: May 14, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
2
Primary Endpoint
Acceptability of the BOKS + SFSP Programs

Study Overview

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 USDA's 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 USDA's 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Research staff who completes assessments will not be aware of random assignment

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Reside in the low-income, Rhode Island community where BOKS program is offered
  • Quality for free meals as part of the NSLP, which is equivalent to a family of four having an annual income less than $43,568 in the state of Rhode Island.
  • Ages 6-12 years
  • Ability of the child to speak, read and write English (for purposes of the focus groups and intervention)
  • Agreement to randomization

Exclusion Criteria

  • Inability to participate in routine physical activity

Outcomes

Primary Outcomes

Acceptability of the BOKS + SFSP Programs

Time Frame: 8 weeks

Attendance in the SFSP

Secondary Outcomes

  • Excess Summer Weight gain(8 weeks)
  • Respiratory Fitness(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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