- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132869
YES! We Can PLAY: A Physical Activity and Nutrition After-School Program for Middle School Students
YES! We Can PLAY: A Physical Activity and Nutrition After School Program for 6th Graders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Physical Activity Guidelines for Americans recommend that youth engage in 60 minutes of MVPA per day, but most U.S. youth do not meet this goal. Already inadequate levels of physical activity drop still further as children transition from elementary school to middle school; during this transition sports participation and overall physical activity decrease. According to data from the Centers for Disease Control and Prevention Youth Risk Behavior Survey data from 2009, the most recent year for which Alabama data is available for middle-school students, only 30% or fewer of the responding youth reported adherence to Physical Activity Guidelines for Americans. Additional data indicates these poor health behaviors in middle school carry forward into high school. Ninth graders in Alabama report low levels of vegetable and fruit consumption, with roughly 10% of the students indicating that they had eaten no fruit or vegetables at all in the 7 days prior to the survey. In a study conducted in Birmingham, researchers found that school-based resources were the most important determinants of physical activity among youth ages 12-14. This information is particularly meaningful when placed in context with the high prevalence of sedentary behavior among Birmingham youth.
Because physical activity and sports participation decrease in the transition to middle school, interventions that provide opportunities for physical activity and sports participation for middle school students have the potential to impact the short-term and long-term health of youth. In Alabama middle schools, only 7th and 8th graders are eligible to play on Alabama High School Athletic Association (AHSAA) sports teams, leaving 6th graders who do not have access to club or recreational sports due to finances, transportation or other issues related to poverty, with few options for participating in organized sports. For students who live in neighborhoods that experience high rates of crime, informal physical activity options are rare as well. Lack of opportunities for both organized and informal physical activity may lead 6th graders to drop sports participation altogether, which could impact lifetime physical activity habits and lead to lower health status.
The school setting is a prime location for improving eating habits and increasing physical activity since schools have direct contact with the children for about eight hours a day, and out of school time programs have been shown to be a desirable environment for such intervention and can be effective in promoting higher fruit and vegetable intake, as well as increased physical activity. Currently the Birmingham City Schools District for 3rd through 5th graders. Let's Move began over 15 years ago and has evolved since. There are approximately 1300 students that participate in some of the Let's Move program components, which include 2 days per week of after-school sports programming. The program emphasizes basic skills instruction while encouraging a positive, fitness-oriented, after-school program supporting healthy lifestyles. Let's Move serves as important foundation for the organization and implementation of the proposed program as it expands the content and elevates the target audience to middle school students. Due to COVID restrictions, the YES! program will operate virtually. in out of school time. During the 2020-2021 school year the program took place virtually will after school at least 3 days per week. Once public health guidelines allowed for in person programming, participants could choose to take part in the program face-to-face at his/her school (during the school year) or at the YMCA of Birmingham's Youth Center (during the summer).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35205
- University of Alabama at Birmingham
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Birmingham, Alabama, United States, 35209
- The University of Alabama at Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In 6th-8th grade in targeted middle schools
- Age 11-15 at the time of enrollment
- Be able to attend an after school program daily
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
In Spring of 2020, all 6th graders in Wave 1 intervention schools (6 schools), which include 561 total 6th graders, will be invited to participate the intervention.
Those in the experimental group will complete all measures according to the timeline.
Those not in the experimental group will also complete the intervention, but will not participate in measurements.
In Fall 2020 all 6th graders who attend the Wave 2 intervention schools (schools that were the control schools in Spring), will be invited to participate the intervention.
Those in the experimental group will complete all measures on schedule.
*Note these activities were delay due to schools shutting down in March 2020 because of COVID-19 In Fall 2021 all 6th graders who attend the Wave 3 intervention schools, will be invited to participate the intervention.
Those in the experimental group will complete all measures on schedule.
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Sixth graders will participate in a 6 month after-school program in which each daily session will last 90 minutes, 60 minutes of which will be moderate to vigorous physical activity.
Two sports tracks will be offered during each 8-week season, and children will choose which they prefer.
Coaches will be trained through a one day capacity building session and will receive online training throughout the program.
Coaches will integrate sports readiness/physical activity programming, nutrition and healthy eating, and social emotional learning into the program with a focus on habit formation.
A text-based platform will be utilized to encourage habits learned in the active portion of the program during June and July as well as on weekends during the intervention.
Parents will be sent fliers weekly summarizing concepts addressed, and will be invited to cooking classes to watch students compete.
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No Intervention: Control group
Wave 1 comparison schools (2 Schools) have a total of 267 6th graders.
Students will be invited to join the comparison group.
and will have measurements taken at baseline and 6 months.
Wave 2 comparison schools (3 Schools) have a total of 363 6th graders adn will be invited to join the comparison group and will have measurements taken at baseline and 6 months.
These students will continue with their normal activities as usual.*Note
these activities were delay due to schools shutting down in March 2020 because of COVID-19
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minutes of MVPA per day - accelerometer
Time Frame: Baseline
|
Number of minutes of MVPA per day - recorded by accelerometer
|
Baseline
|
Minutes of MVPA per day - accelerometer
Time Frame: 3 months
|
Number of minutes of MVPA per day - recorded by accelerometer
|
3 months
|
Minutes of MVPA per day - accelerometer
Time Frame: 6 months
|
Number of minutes of MVPA per day - recorded by accelerometer
|
6 months
|
Fruit and Vegetable Consumption
Time Frame: Baseline
|
Number of servings of fruits and vegetables
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Baseline
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Fruit and Vegetable Consumption
Time Frame: 3 months
|
Number of servings of fruits and vegetables
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3 months
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Fruit and Vegetable Consumption
Time Frame: 6 months
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Number of servings of fruits and vegetables
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6 months
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Days of Physical Activity
Time Frame: baseline
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Number of days getting 60 minutes or more of physical activity
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baseline
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Days of Physical Activity
Time Frame: 3 months
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Number of days getting 60 minutes or more of physical activity
|
3 months
|
Days of Physical Activity
Time Frame: 6 months
|
Number of days getting 60 minutes or more of physical activity
|
6 months
|
Sugar Sweetened Beverages
Time Frame: baseline
|
Number of SSB servings per day
|
baseline
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Sugar Sweetened Beverages
Time Frame: 3 months
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Number of SSB servings per day
|
3 months
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Sugar Sweetened Beverages
Time Frame: 6 months
|
Number of SSB servings per day
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6 months
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Water
Time Frame: baseline
|
Number of servings of water per day
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baseline
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Water
Time Frame: 3 months
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Number of servings of water per day
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3 months
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Water
Time Frame: 6 months
|
Number of servings of water per day
|
6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lori B Bateman, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 ASTWH190077-01-00 (Other Grant/Funding Number: Department of Health and Human Services)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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