Summer Food Service Program
Primary Purpose
Pediatric Obesity, Exercise
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOKS
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Summer, Physical Activity, Health disparities
Eligibility Criteria
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
Sites / Locations
- Weight Control and Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BOKS + SFSP
SFSP
Arm Description
Children randomized to the BOKS + SFSP will be invited to attend the one-hour BOKS program four days per week for eight weeks during the summer. The BOKS program will be run by Lifespan employed staff in the hour before the SFSP lunch service at two community locations.
Children randomized to the SFSP alone group will be asked to participate in the SFSP as they would have otherwise.
Outcomes
Primary Outcome Measures
Acceptability of the BOKS + SFSP Programs
Attendance in the SFSP
Secondary Outcome Measures
Respiratory Fitness
Pacer Test
Excess Summer Weight gain
Change in BMIz
Full Information
NCT ID
NCT04544137
First Posted
September 3, 2020
Last Updated
September 3, 2020
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04544137
Brief Title
Summer Food Service Program
Official Title
Evaluation and Enhancement of the Summer Food Service Program in Youth From an Urban, Low-resource Community
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Exercise
Keywords
Summer, Physical Activity, Health disparities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research staff who completes assessments will not be aware of random assignment
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOKS + SFSP
Arm Type
Experimental
Arm Description
Children randomized to the BOKS + SFSP will be invited to attend the one-hour BOKS program four days per week for eight weeks during the summer. The BOKS program will be run by Lifespan employed staff in the hour before the SFSP lunch service at two community locations.
Arm Title
SFSP
Arm Type
No Intervention
Arm Description
Children randomized to the SFSP alone group will be asked to participate in the SFSP as they would have otherwise.
Intervention Type
Behavioral
Intervention Name(s)
BOKS
Intervention Description
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 Outcome Measure Information:
Title
Acceptability of the BOKS + SFSP Programs
Description
Attendance in the SFSP
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Respiratory Fitness
Description
Pacer Test
Time Frame
8 weeks
Title
Excess Summer Weight gain
Description
Change in BMIz
Time Frame
8 weeks
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:
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
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Summer Food Service Program
We'll reach out to this number within 24 hrs