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

August 31, 2026 updated by: Tony Babb, University of Texas Southwestern Medical Center
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prevalence of childhood obesity increases with age (20.7% aged 6-11 & 22.2% aged 12-19; NHANES 2017-2020). CWO, compared with CWOO, are more likely to have chronic health conditions.

Results from the investigator's prior grant (HL136643) show that over one year, CWO can add four times as much fat weight as CWOO. However, it is unknown if this rate of increase in fat weight continues into adolescence and early adulthood, and whether respiratory function, exercise tolerance, or DOE are progressively worsened by increasing obesity. Furthermore, there could be a sex difference in the effects of obesity, given the different growth characteristics for boys and girls.

The investigator's long-term objective is to investigate the effects of 6 years of aging on body composition, respiratory function, exercise tolerance, and DOE in CWO and CWOO.

Specific Aims: The investigators will test the following hypotheses in CWO and CWOO after 6 years of aging:

Aim 1) CWO originally studied at 8-12 years old will demonstrate a greater increase in fat weight and lower respiratory function (i.e., altered pulmonary function & breathing mechanics at rest) than in CWOO originally studied at 8-12 years old;

Aim 2) CWO originally studied at 8-12 years old will demonstrate lower exercise tolerance measured during graded cycle ergometry (as evidenced by peak V • O2 in ml/min/kg, i.e., physical fitness) than in CWOO originally studied at 8-12 years old, but not lower cardiorespiratory fitness (as evidenced by peak V • O2 in % of predicted based on ideal body wt., i.e. cardiorespiratory fitness);

Aim 3) CWO originally studied at 8-12 years old will demonstrate greater DOE as evidenced by increased ratings of perceived breathlessness during constant load exercise cycling than in CWOO originally studied at 8-12 years old; and

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Children Without Obesity
No intervention or treatment will be administered. This group will not return after initial visits.
Children With Obesity
No intervention or treatment will be administered. This group will not return after initial visits.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulmonary Function: Lung Volumes
Time Frame: Change 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)
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Exercise Tolerance - Peak VO2
Time Frame: Change 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)
Change 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
Time Frame: Change 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.
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary Function: Spirometry
Time Frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Spirometry includes: Forced vital capacity (% predicted), Forced Expiratory Volume in 1 second (FEV1) (% predicted), FEV1/FVC (% predicted), and peak flow (% predicted.)
Change 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: Diffusing Capacity
Time Frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Diffusing Capacity: Diffusing capacity of lung for carbon monoxide(DLco) (ml/mmHg/min)
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Exercise Tolerance: Work Rate
Time Frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Associated variables such as work rate (W)
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Exercise Tolerance: Minute Ventilation
Time Frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study..
Associated variables such as pulmonary ventilation (L/min)
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study..
Exercise Tolerance: Operational Lung Volumes
Time Frame: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Associated variables such as operational lung volumes (EELV and EILV as a % of TLC)
Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tony G Babb, Ph.D., University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-2024-0444
  • 5R01HL136643-05 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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