Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07342855

Conditions

Pediatric Obesity

Pediatric Overweight

Overweight , Obesity

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Interventions

Get Up & Go Healthy Lifestyle Program

Study Details

Brief summary:

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.

Conditions

Pediatric Obesity

Pediatric Overweight

Overweight , Obesity

Study ID

NCT07342855

Start date

Jan 15, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI by report of ≥ 85th percentile
  • The child must be able to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old

Exclusion Criteria:

  • BMI by report of below the 85th percentile
  • Inability to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old

Parent will be invited but not required to be weighed and measured.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Program Intervention Arm

Participation in Get Up \& Go Healthy Lifestyle Program

no intervention: Waitlist Control Arm

Waitlist control patients will participate in the program 3 months later

Interventions

Get Up & Go Healthy Lifestyle Program

This study evaluates an established pediatric healthy weight program, Get Up \& Go. There are 10 weekly sessions for child (ages 6-14 years) and parent. Each 90-minutes session includes an interactive lesson on some aspect of healthy living, a fun game or physical activity that involves both children and parents, a healthy snack, and a time for families to set a lifestyle change goal for the week and to review achievement of goals set the prior week. Virtual components bring the total content exposure to over 26 hours provided.

Curriculum:

Principles of healthy living Healthy eating basics Division of responsibility Nutrition 101 Bullying prevention Meal time Advertising and dining Grocery store tour Graduation

Primary outcome measure

  • BMI status [ Time Frame: From enrollment to the end of intervention period at 3 months ]

Central Contacts and Locations

Central contacts

Sarah E Barlow, MD, MPH

12144565466sarah.barlow@utsouthwestern.edu

Victoria Nelson

214 676 5618victoria.nelson@childrens.com

Locations

University of Texas Southwestern, Children's Health

Recruiting

Dallas, Texas, United States, 75235

Contacts

Sarah E Barlow, MD, MPH

214-456-8000Sarah.Barlow@UTSouthwestern.edu

Victoria Nelson

214-456-9429victoria.nelson@childrens.com

Principal Investigator:

Sarah Barlow, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Obesity
  • FNPA
  • BAQ
  • Endurance
  • %BMIp95
  • Family Healthy Weight Program
  • Community Healthy Lifestyle Program
  • intensive health behavior and lifestyle treatment
  • PACER

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-30.