NCT04132869

Brief Summary

YES! We can PLAY: A Physical Activity and Nutrition After-School Program for Middle School Students, is a collaborative partnership between the University of Alabama at Birmingham and the Birmingham City Schools District to decrease health disparities in obesity and obesity-related diseases by increasing physical activity levels and healthy eating behavior among Birmingham youth. Through the after-school program in which children choose from a menu of sports programming, the proposed intervention will increase physical literacy of the students through education related to both physical activity and nutrition as well as social-emotional learning which will increase students' ability to integrate the information and activities of the program into their lives moving forward.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

October 14, 2019

Last Update Submit

January 29, 2023

Conditions

Keywords

physical activitysocial emotional learninghealthy eatingsports readiness

Outcome Measures

Primary Outcomes (15)

  • Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    Baseline

  • Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    3 months

  • Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    6 months

  • Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    Baseline

  • Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    3 months

  • Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    6 months

  • Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    baseline

  • Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    3 months

  • Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    6 months

  • Sugar Sweetened Beverages

    Number of SSB servings per day

    baseline

  • Sugar Sweetened Beverages

    Number of SSB servings per day

    3 months

  • Sugar Sweetened Beverages

    Number of SSB servings per day

    6 months

  • Water

    Number of servings of water per day

    baseline

  • Water

    Number of servings of water per day

    3 months

  • Water

    Number of servings of water per day

    6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Sports Readiness Intervention

Control group

NO INTERVENTION

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

Interventions

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.

Experimental Group

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Lori B Bateman, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This research study uses a cluster randomized design who attend the intervention schools. For the control group, we will invite students from comparison schools that do not participate in the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 21, 2019

Study Start

January 13, 2020

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations