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Child ObesityNCT04132869

YES! We Can PLAY: A Physical Activity and Nutrition After-School Program for Middle School Students

A study testing Sports Readiness Intervention in people with Child Obesity, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Child Obesity
What is being tested?
Sports Readiness Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
2 sitesUnited States
Study dates
13 Jan 2020to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35209

Other trials in United States

About this study

Official title: YES! We Can PLAY: A Physical Activity and Nutrition After School Program for 6th Graders

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.

Read the 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).

Conditions
Child Obesity
Being tested
Sports Readiness Intervention
Keywords
physical activity, social emotional learning, healthy eating, sports readiness
Medical subject headings
Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sports Readiness InterventionBehavioural

    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.

Study groups in NCT04132869
Study groupRoleWhat they receive
Experimental GroupExperimentalIn 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.
Receives: Behavioral: Sports Readiness Intervention
Control groupNo interventionWave 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    Measured: Baseline

  2. Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    Measured: 3 months

  3. Minutes of MVPA per day - accelerometer

    Number of minutes of MVPA per day - recorded by accelerometer

    Measured: 6 months

  4. Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    Measured: Baseline

  5. Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    Measured: 3 months

  6. Fruit and Vegetable Consumption

    Number of servings of fruits and vegetables

    Measured: 6 months

  7. Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    Measured: baseline

  8. Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    Measured: 3 months

  9. Days of Physical Activity

    Number of days getting 60 minutes or more of physical activity

    Measured: 6 months

  10. Sugar Sweetened Beverages

    Number of SSB servings per day

    Measured: baseline

  11. Sugar Sweetened Beverages

    Number of SSB servings per day

    Measured: 3 months

  12. Sugar Sweetened Beverages

    Number of SSB servings per day

    Measured: 6 months

  13. Water

    Number of servings of water per day

    Measured: baseline

  14. Water

    Number of servings of water per day

    Measured: 3 months

  15. Water

    Number of servings of water per day

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start13 Jan 2020
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132869
Sponsor's protocol ID
1 ASTWH190077-01-00
Other IDs
1 ASTWH190077-01-00
Status last verified
Jan 2023
First submitted
14 Oct 2019
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sports Readiness Intervention in people with Child Obesity, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minutes of MVPA per day - accelerometer (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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