Healthy Lifestyle Program for Childhood Obesity

Overseen By Victoria Nelson

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Low BMI, Physical limitations, Cognitive limitations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.

Are You a Good Fit for This Trial?

This trial is for children with obesity, defined as having a BMI at or above the 85th percentile. Participants should be capable of engaging in physical activities similar to an elementary school PE class and have cognitive abilities at least on par with a typical 6-year-old.

Inclusion Criteria

My BMI is in the 85th percentile or higher.

My child can do physical activities like in PE class and thinks as well as a 6-year-old or better.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Baseline Measurement

Baseline measures are taken including height, weight, and endurance tests. Families are randomized to immediate participation or waitlist control.

1 hour

1 visit (in-person)

Intervention

Participants in the intervention arm begin the Get Up & Go Healthy Lifestyle Program immediately.

3 months

Waitlist Control

Participants in the waitlist control arm defer participation for approximately 3 months.

3 months

Follow-up

Participants are monitored for changes in BMI status and other health metrics after the intervention period.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Get Up & Go Healthy Lifestyle Program

Trial Overview

The study is testing the 'Get Up & Go Healthy Lifestyle Program,' which educates families about maintaining a healthy lifestyle. Children will be randomly assigned to start the program immediately or placed on a waitlist, serving as controls.

How Is the Trial Designed?

Group I: Program Intervention Arm Experimental Treatment 1 Intervention

Participation in Get Up \& Go Healthy Lifestyle Program

Group II: Waitlist Control Arm Active Control 1 Intervention

Waitlist control patients will participate in the program 3 months later

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Children's Medical Center Dallas

Collaborator

Trials

23

Recruited

5,012,000+