Summer Food Service Program

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544137
• Other study ID #: 207716
• Status: Completed
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Pediatric Obesity

Intervention

Behavioral:
• BOKS
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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the BOKS + SFSP Programs	Attendance in the SFSP	8 weeks
Secondary	Respiratory Fitness	Pacer Test	8 weeks
Secondary	Excess Summer Weight gain	Change in BMIz	8 weeks