NCT07342855

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

January 6, 2026

Last Update Submit

March 25, 2026

Conditions

Pediatric OverweightOverweight , ObesityPediatric Obesity

Keywords

ObesityFNPABAQEndurance%BMIp95Family Healthy Weight ProgramCommunity Healthy Lifestyle Programintensive health behavior and lifestyle treatmentPACER

Outcome Measures

Primary Outcomes (1)

  • BMI status

    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 Outcomes (4)

  • Family Nutrition and Physical Activity (FNPA)

    From enrollment to the end of intervention period at 3 months

  • BAQ: Behavior Assessment Questionnaire

    From enrollment to the end of intervention period at 3 months

  • Endurance (PACER)

    From enrollment to the end of intervention period at 3 months

  • Parental Weight Measures

    From enrollment to the end of intervention period at 3 months

Study Arms (2)

Program Intervention Arm

EXPERIMENTAL

Participation in Get Up \& Go Healthy Lifestyle Program

Behavioral: Get Up & Go Healthy Lifestyle Program

Waitlist Control Arm

NO INTERVENTION

Waitlist control patients will participate in the program 3 months later

Interventions

Get Up & Go Healthy Lifestyle ProgramBEHAVIORAL

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

Program Intervention Arm

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern, Children's Health

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (6)

  • O'Connor EA, Evans CV, Henninger M, Redmond N, Senger CA. Interventions for Weight Management in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2024 Jul 16;332(3):233-248. doi: 10.1001/jama.2024.6739.

    PMID: 38888913BACKGROUND

  • O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332.

    PMID: 28632873BACKGROUND

  • Barlow SE, Lorenzi A, Reid A, Huang R, Yudkin JS, Messiah SE. The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. Child Obes. 2021 Oct;17(7):432-441. doi: 10.1089/chi.2021.0010. Epub 2021 May 3.

    PMID: 33945306BACKGROUND

  • Chiong R, Gray VB, Roy R. Development of a Family-Based Nutrition Program Rooted in Food Parenting Literature. Fam Consum Sci Res J. 2020 Sep;49(1):67-83. Epub 2020 Aug 28.

    PMID: 33239856BACKGROUND

  • Yudkin JS, Allicock MA, Atem FD, Galeener CA, Messiah SE, Barlow SE. Efficacy of a Primary Care eHealth Obesity Treatment Pilot Intervention Developed for Vulnerable Pediatric Patients. Child Obes. 2024 Mar;20(2):75-86. doi: 10.1089/chi.2022.0185. Epub 2023 Mar 9.

    PMID: 36893214BACKGROUND

  • Ihmels MA, Welk GJ, Eisenmann JC, Nusser SM. Development and preliminary validation of a Family Nutrition and Physical Activity (FNPA) screening tool. Int J Behav Nutr Phys Act. 2009 Mar 12;6:14. doi: 10.1186/1479-5868-6-14.

    PMID: 19284631BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric ObesityOverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Barlow, MD, MPH

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Barlow, MD, MPH

CONTACT

12144565466sarah.barlow@utsouthwestern.edu

Victoria Nelson

CONTACT

214 676 5618victoria.nelson@childrens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control group procedures 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Principal Investigator

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Patient BMI changes, pacer results, questionnaire results.

Shared Documents
STUDY PROTOCOL, CSR
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.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal. Data will can be sent via a secure method.

Locations

US(1)