Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program (73357)

March 25, 2026 updated by: Sarah Barlow, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants will come from the cohort of patients who are referred to the Get Up & Go program and decide to enroll. For this existing family healthy weight program, the child must be between 6 and 14 years of age at time of program start, with 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.

The process for enrollment in this program begins with a standard referral that goes to the Get Up & Go office at Children's Health. Staff will make referred families aware of study at initial contact; staff generally place a call to families to give overview of Get Up & Go. Office staff tell interested families that they will be contacted closer to the time of class start. Whether or not the family answers the phone, the family is mailed a welcome packet.

For the study, the Get Up & Go staff will inform families by phone that they may qualify for a study that performs additional measures to help understand the effect of the program. These families will hear that study participation is optional. The staff will tell the families that a study coordinator will call or text unless the family says they do not want to be contacted. The welcome packet will include a page with the same information and an opt-out postcard. To enroll in this study, the parent must speak English or Spanish.

The study coordinator will call families who have not declined contact, up to 5 times at different times of day. When they reach the family, they will review the study protocol and invite participation. The coordinator will review the study protocol, explaining that participation will mean a 1-hour visit measure several weeks prior to class start and agreement to accept randomization to immediate start or 3 months deferment. If family wants to enroll, the consent will be reviewed, and all questions answered. The parent will verbally consent and will receive a copy of the (unsigned per IRB waiver) consent via email. The child will assent. If families prefer, they can defer consent or assent until the in-person appointment for measurement.

A study coordinator will schedule a time 1-4 weeks before the start of the Get Up & Go class to meet with a small group (1-5) of study families at either the YMCA or at Children's Health to perform baseline measures. If any families were interested but did not consent virtually, they will undergo consenting process at this time. When measures (see description below) are complete, a simple 1:1 randomization will be done, using a computer software program that generates random sequence. Neither research team nor family will be blinded to assignment

  1. Intervention: immediate participation
  2. Control: Waitlist, deferring participation for approximately 3 months, to the next quarter

The wait list control subjects will receive no intervention for 3 months. They will undergo a Time 2 measure and then begin participation in the session at the subsequent quarter.

Data collected will include height, weight, %BMIp95, endurance via PACER test. Survey data: The Family and Nutrition and Physical Activity (FNPA) and Behavior Assessment Questionnaire (BAQ).

Optional data: Parental height, weight, and BMI.

Each quarter, approximately 40 families will be enrolled, with 20 randomized to start immediately and 20 to wait until the subsequent quarter. Cohorts will be recruited each quarter for 4-5 quarters until enrollment is complete.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern, Children's Health
        • Principal Investigator:
          • Sarah Barlow, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alex E Wright, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Program Intervention Arm
Participation in Get Up & Go Healthy Lifestyle Program
Behavioral: 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
No Intervention: Waitlist Control Arm
Waitlist control patients will participate in the program 3 months later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI status
Time Frame: From enrollment to the end of intervention period at 3 months
Change in child BMI status, using %BMIp95 as primary outcome and BMI z score. Both are calculations made from weight, height, sex, and age.
From enrollment to the end of intervention period at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance (PACER)
Time Frame: From enrollment to the end of intervention period at 3 months
Progressive Aerobic Cardiovascular Endurance Run (PACER): participants run a 15 m distance at a progressively faster pace, and the score is the number of laps successfully completed
From enrollment to the end of intervention period at 3 months
Parental Weight Measures
Time Frame: From enrollment to the end of intervention period at 3 months
Optional: Parent BMI, using absolute BMI (kg/m2)
From enrollment to the end of intervention period at 3 months
Family Nutrition and Physical Activity (FNPA)
Time Frame: From enrollment to the end of intervention period at 3 months

Family Nutrition and Physical Activity (FNPA), a validated 30-item questionnaire from the Academy of Nutrition and Dietetics, will be completed by parent.

The questions ask about home practices related to nutrition, physical activity, sleep and other health routines. The instrument has been broadly utilized since it was validated in 2009 . The FNPA has been used to assess modifiable healthy lifestyle behaviors, with an emphasis on behaviors that contribute to obesity .

Each questions are rated on a scale of 1 to 4. Higher aggregate scores point to healthier decision making. Lower scores point to less healthy behaviors.
From enrollment to the end of intervention period at 3 months
BAQ: Behavior Assessment Questionnaire
Time Frame: From enrollment to the end of intervention period at 3 months
Behavior Assessment Questionnaire (BAQ) is a self reported tool measuring a child's lifestyle behaviors. It examines frequency of habits such as eating, activity, emotional health, sleep, and environment. Each of the 10 questions has 4 response options describing frequency or timing of stem question. The responses are assigned scores of 0-4, and total scores are converted to a 0-100 scale. Higher aggregate scores point to healthier habits, and lower scores point to less healthy behaviors.
From enrollment to the end of intervention period at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Children's Medical Center Dallas

Investigators

  • Principal Investigator: Sarah Barlow, MD, MPH, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20250787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient BMI changes, pacer results, questionnaire results.

IPD Sharing Time Frame

Deidentified IPD underlying the results reported for the study can be available beginning 6 months after publication and ending 3 years after publication.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal. Data will can be sent via a secure method.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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