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Children With Obesity (Control) for Childhood Obesity

N/A
Waitlist Available
Led By Tony G Babb, Ph.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in differences between nonobese and obese children. outcome measures will be assessed within 48-72 hours after completion of each study..
Awards & highlights

Summary

The purpose of the study is to re-examine body composition, respiratory function, exercise tolerance, and dyspnea on exertion (DOE) in children with obesity (CWO) and children without obesity (CWOO) who were originally studied as 8-12-year-olds between 2016-2023 (i.e., originally Tanner score ≤ 3; 90 participants; 26 CWOO \& 64 CWO).

Eligible Conditions
  • Childhood Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in differences between nonobese and obese children. outcome measures will be assessed within 48-72 hours after completion of each study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in differences between nonobese and obese children. outcome measures will be assessed within 48-72 hours after completion of each study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dyspnea on Exertion
Exercise Tolerance - Peak VO2
Pulmonary Function: Lung Volumes
Other study objectives
Exercise Tolerance: Minute Ventilation
Exercise Tolerance: Operational Lung Volumes
Exercise Tolerance: Work Rate
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Children Without ObesityExperimental Treatment0 Interventions
No intervention or treatment will be administered. This group will not return after initial visits.
Group II: Children With Obesity (Control)Experimental Treatment0 Interventions
No intervention or treatment will be administered. This group will return 9 months for repeat testing/follow up after initial visit.
Group III: Children With ObesityExperimental Treatment1 Intervention
Voluntary Weight Loss: Completion of weight loss follow up and 6-month post weight loss testing. The investigators are not studying the effectiveness a weight loss intervention, nor the rate of weight loss, nor any specific AOM. Participation in the weight loss program will be optional. The CWO who elect to participate in the weight loss option will receive standard of care by co-investigator Dr. Barlow for their weight loss program.

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,172 Total Patients Enrolled
Tony G Babb, Ph.D.Principal InvestigatorUniversity of Texas Southwestern Medical Center
3 Previous Clinical Trials
246 Total Patients Enrolled
~60 spots leftby Aug 2029
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