Childhood ObesityNCT06447246
Respiratory Effects of Obesity in Children: Longitudinal Consequences After 6 Years of Aging
An observational study of Childhood Obesity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 31 Aug 2029
- Phase
- Observational
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.
Who may be able to join
- The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.
Who cannot join
- Children not able to follow directions, adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing).
- 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.
- 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.
- 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.
- 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.
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
Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
About this study
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).
Read the 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
- Conditions
- Childhood Obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children With Obesity | No intervention or treatment will be administered. This group will not return after initial visits. | |
| Children Without Obesity | No intervention or treatment will be administered. This group will not return after initial visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function: Lung Volumes
Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters)
Measured: 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
Exercise Tolerances is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted)
Measured: 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
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.
Measured: Change from Baseline in differences between nonobese and obese children. Outcome measures will be assessed within 48-72 hours after completion of each study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start23 Aug 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Tony Babb, University of Texas Southwestern Medical Center
- Investigators
- Tony G Babb, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447246
- Sponsor's protocol ID
- STU-2024-0444
- Other IDs
- 5R01HL136643-05
- Status last verified
- Aug 2026
- First submitted
- 29 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effects of Obesity in Children: Longitudinal Consequences After 6 Years of Aging
- ClinicalTrials.gov ID
- NCT06447246
- Acronym / sponsor ID
- STU-2024-0444
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 7 Jun 2024 (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.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children With Obesity | – | –No intervention or treatment will be administered. This group will not return after initial visits. |
| Children Without Obesity | – | –No intervention or treatment will be administered. This group will not return after initial visits. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.
Key inclusion criteria (1 listed)
- The participants originally studied as 8-12-year-olds between 2016-2023 as part of the investigator's R01 HL136643.
Key exclusion criteria (5 listed)
- Children not able to follow directions, adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing).
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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.
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 3 Sep 2026.
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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.
Tony G Babb, Ph.D. 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?
An observational study of Childhood Obesity, 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 1 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.