Clinical trial

Respiratory Effects of Obesity in Children: Longitudinal Consequences After 6 Years of Aging

Invitation only · Not applicable · 1 countries · Registry ID NCT06447246

Invitation onlyNot applicableObservational

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 18 Years
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity

Full registry criteria

Inclusion Criteria: The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643. Exclusion Criteria: 1. Children not able to follow directions, adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing). 2. If a child developed an abnormal ECG, showed other signs of clinical exercise intolerance, or signs of cardiovascular/lung disease during the exercise test, testing was terminated, and the child was referred to their personal physician for further evaluation. 3. Women who are pregnant or could possibly be pregnant (i.e. not using approved birth control measures and sexually active) will be excluded because of changes in body size during pregnancy and because unforeseeable risks to the fetus. 4. Presence of significant disease defined as a disease which in the opinion of the investigator may put the subject at risk because of participation in the study or a disease that may influence the results of the study or the subject's ability to participate in the study. 5. Patients who are non-English speaking will be excluded from the study because the tests performed are very effort dependent, detailed and require technical communication between the staff and the patient. The investigators feel that a translator would not be able to translate the technical terms fast enough to instruct the patient in the testing.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Pulmonary Function: Lung VolumesChange from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters)

Exercise Tolerance - Peak VO2Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

Exercise Tolerances is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted)

Dyspnea on ExertionChange from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

Dyspnea on Exertion is represented using the Borg Scale which provides Ratings of Perceived Breathlessness (RPB) during constant load exercise cycling. The Borg Scale measures from 0-10, where 0 = no breathlessness and 10 = maximal breathlessness.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas🇺🇸 Dallas, Texas, United States