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Completed

NCT Number: NCT04544137

Summer Food Service Program

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOKS

Behavioral

BOKS is an evidence-based physical activity program developed by Reebok to get kids active and establish a lifelong commitment to health and fitness. It was originally developed and tested as a 12-week program offered before or after school. In the present study, BOKS will be offered four days per week for eight weeks over the summer at a public park in one low-income community. The program will run one-hour prior to lunch service by the USDA's Summer Food Service Program. The BOKS curriculum includes lesson plans for 40-45 minute classes that follow the same daily format and focus on a functional fitness skill of the week (squat, plank, push up, etc) and engage participants in team-oriented games.

Primary outcomes

  1. Acceptability of the BOKS + SFSP Programs

    Time frame: 8 weeks

    Attendance in the SFSP

Secondary outcomes

  1. Respiratory Fitness

    Time frame: 8 weeks

    Pacer Test

  2. Excess Summer Weight gain

    Time frame: 8 weeks

    Change in BMIz

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2020
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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