Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program
NCT ID: NCT07342855
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2026-01-15
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Program Intervention Arm
Participation in Get Up \& Go Healthy Lifestyle Program
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
Waitlist Control Arm
Waitlist control patients will participate in the program 3 months later
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
14 Years
ALL
No
Sponsors
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Children's Medical Center Dallas
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Sarah Barlow
Professor of Pediatrics, Principal Investigator
Locations
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University of Texas Southwestern, Children's Health
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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73357
Identifier Type: -
Identifier Source: org_study_id
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