Actively Recruiting

Phase Not Applicable
Age: 6Years - 14Years
All Genders
ID07342855

Comparison Study to Evaluate the Outcomes Among Children Participating in a Community Healthy Lifestyle Program

Led by University of Texas Southwestern Medical Center · Updated on 2026-03-30

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

C

Children's Medical Center Dallas

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the outcomes of a community healthy lifestyle program called Get Up & Go, designed for children aged 6 to 14 years with overweight or obesity. This program aims to teach families healthy habits through interactive lessons and physical activities. The study uses an unblinded, randomized, waitlist control design to compare immediate participation versus delayed participation in the program. The Get Up & Go program includes 10 weekly sessions lasting 90 minutes each, involving both children and their parents. Each session features a lesson on healthy living, a game or physical activity, a healthy snack, and goal-setting for lifestyle changes. Virtual components provide over 26 hours of total content exposure. Participants are randomly assigned to start the program immediately or wait approximately 3 months before beginning. Participants will complete baseline measurements including height, weight, BMI percentile, endurance via the PACER test, and surveys on family nutrition and behavior. Optional parental measurements may also be collected. Follow-up assessments occur after the intervention period of 3 months to evaluate changes in BMI and other health behaviors. The study will enroll about 40 families each quarter over several quarters, with monitoring and data collection throughout the study period ending in mid-2027.

CONDITIONS

Brief Title

Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program

Who Can Participate

Age: 6Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child has a BMI at or above the 85th percentile
  • Child is between 6 and 14 years old at the time of program start
  • Child can participate in physical activity similar to an elementary school PE class
  • Child can function cognitively at or above the level of a 6 year old
  • Parent must speak English or Spanish to enroll in the study
Not Eligible

You will not qualify if you...

  • Child has a BMI below the 85th percentile
  • Child cannot participate in physical activity similar to an elementary school PE class
  • Child cannot function cognitively at or above the level of a 6 year old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 weeks

Participants attend the Get Up & Go Healthy Lifestyle Program, which consists of 10 weekly sessions including interactive lessons, physical activities, and goal setting focused on healthy living.

Weekly visits for 10 weeks

Follow-up

Duration - 3 months

Participants in the waitlist control group undergo a 3-month observation period without intervention before starting the program.

1 to 2 visits depending on timing of measurements

Trial Site Locations

Total: 1 location

1

University of Texas Southwestern, Children's Health

Dallas, Texas, United States, 75235

Actively Recruiting

Loading map...

Research Team

S

Sarah E Barlow, MD, MPH

V

Victoria Nelson

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Phase I Clinical Study to Evaluate the Pharmacokinetic Cha...

Overweight , Obesity

Actively Recruiting

3 locations

A Phase I, Randomized, Double-Blind, Placebo-Controlled Stud...

Overweight , Obesity

Actively Recruiting

1 location

A Clinical Efficacy Study of Asiaticoside for Treating Overw...

Overweight , Obesity

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Interventions for Weight Management in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Elizabeth A O'Connor, Corinne V Evans, Michelle Henninger...

https://pubmed.ncbi.nlm.nih.gov/38888913

Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Elizabeth A O'Connor, Corinne V Evans, Brittany U Burda...

https://pubmed.ncbi.nlm.nih.gov/28632873

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work.

Sarah E Barlow, Anna Lorenzi, Aleksei Reid...

https://pubmed.ncbi.nlm.nih.gov/33945306

Efficacy of a Primary Care eHealth Obesity Treatment Pilot Intervention Developed for Vulnerable Pediatric Patients.

Joshua S Yudkin, Marlyn A Allicock, Folefac D Atem...

https://pubmed.ncbi.nlm.nih.gov/36893214