Pediatric Obesity73357NCT07342855
Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program
A study testing Get Up & Go Healthy Lifestyle Program in people with Pediatric Obesity and Pediatric Overweight, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Pediatric Obesity, Pediatric Overweight, Overweight , Obesity
- What is being tested?
- Get Up & Go Healthy Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern, Children's Health
Dallas, Texas, 75235
Sarah E Barlow, MD, MPH, 214-456-8000, Sarah.Barlow@UTSouthwestern.edu
Victoria Nelson, 214-456-9429, victoria.nelson@childrens.com
About this study
Official title: 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.
Read the 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
- Intervention: immediate participation
- 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.
- Being tested
- Get Up & Go Healthy Lifestyle Program
- Keywords
- Obesity, FNPA, BAQ, Endurance, %BMIp95, Family Healthy Weight Program, Community Healthy Lifestyle Program, intensive health behavior and lifestyle treatment, PACER
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get Up & Go Healthy Lifestyle ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Program Intervention Arm | Experimental | Participation in Get Up \& Go Healthy Lifestyle Program Receives: Behavioral: Get Up & Go Healthy Lifestyle Program |
| Waitlist Control Arm | No intervention | Waitlist control patients will participate in the program 3 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention period at 3 months
Secondary outcomes (4)
Family Nutrition and Physical Activity (FNPA)
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.
Measured: From enrollment to the end of intervention period at 3 months
BAQ: Behavior Assessment Questionnaire
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.
Measured: From enrollment to the end of intervention period at 3 months
Endurance (PACER)
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
Measured: From enrollment to the end of intervention period at 3 months
Parental Weight Measures
Optional: Parent BMI, using absolute BMI (kg/m2)
Measured: From enrollment to the end of intervention period at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Responsible party
- Principal investigator, Sarah Barlow, University of Texas Southwestern Medical Center
- Investigators
- Sarah Barlow, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342855
- Sponsor's protocol ID
- STU20250787
- Acronym
- 73357
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient BMI changes, pacer results, questionnaire results.
Publications
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.
PubMed 38888913O'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.
PubMed 28632873Barlow 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.
PubMed 33945306Chiong 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.
PubMed 33239856Yudkin 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.
PubMed 36893214Ihmels 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.
PubMed 19284631
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study to Evaluate the Outcomes Among Children Participating in a Community Healthy Lifestyle Program
- ClinicalTrials.gov ID
- NCT07342855
- Acronym / sponsor ID
- 73357 / STU20250787
- Keywords
- Obesity, FNPA, BAQ, Endurance, %BMIp95, Family Healthy Weight Program, Community Healthy Lifestyle Program, intensive health behavior and lifestyle treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Intervention: immediate participation
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Program Intervention Arm | Experimental | Behavioral: Get Up & Go Healthy Lifestyle ProgramParticipation in Get Up \& Go Healthy Lifestyle Program |
| Waitlist Control Arm | No intervention | –Waitlist control patients will participate in the program 3 months later |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get Up & Go Healthy Lifestyle ProgramThis 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 | Behavioural | Program Intervention Arm |
Primary outcome
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.
4 secondary outcomes
Family Nutrition and Physical Activity (FNPA)
Time frame: 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
Endurance (PACER)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 38888913O'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.
- Background: PubMed 28632873O'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.
- Background: PubMed 33945306Barlow 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.
- Background: PubMed 33239856Chiong 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.
- Background: PubMed 36893214Yudkin 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.
- Background: PubMed 19284631Ihmels 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.
- Get Up \& Go WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient BMI changes, pacer results, questionnaire results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Barlow, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Up & Go Healthy Lifestyle Program in people with Pediatric Obesity and Pediatric Overweight, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah E Barlow, MD, MPH (12144565466, sarah.barlow@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI status (time frame: From enrollment to the end of intervention period at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342855, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.