Childhood ObesityNCT03376880
Respiratory Effects of Obesity in Children
An observational study of Childhood Obesity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory system, particularly during exercise; however, it is unclear if this burden reduces exercise tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be misdiagnosed as asthma, placing obese… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- 1 year follow-up testing
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants included in the study will be prepubescent boys and girls aged 8-12 yr old of all racial and ethnic origins with a Tanner Pubertal Stage of ≤ 3, and the ability to perform pulmonary function and exercise test accurately.
Who may be able to join
- Otherwise healthy with normal lung function; prepubescent (Tanner equal to or less than 3); age and gender specific BMI > 95th percentile, but less than 150% of the 95th percentile based on the CDC standards or age and gender specific BMI between the 16th and 84th percentile based on the Center for Disease Control (CDC) standards; and ability to perform pulmonary and exercise test accurately.
Who cannot join
- Children with significant diseases other than obesity or shortness of breath on exertion will be excluded. Subjects participating in regular conditioning-type vigorous exercise two times or more per week will be excluded (i.e., sports training). Children 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 child.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
About this study
In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory system, particularly during exercise; however, it is unclear if this burden reduces exercise tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be misdiagnosed as asthma, placing obese children at risk of unnecessary treatment and potentially a reluctance to exercise explaining reports of low physical activity and fitness levels, which are counterproductive to weight loss. The investigators will examine the respiratory effects of obesity in prepubescent boys and girls, including those with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with prepubescent normal weight boys and girls before and after 1 year. These results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma, and the results could alter interventional approaches for preventing and treating childhood obesity.
Read the detailed description
In obese children, excess fat exerts an unfavorable burden on the respiratory system, particularly during exercise, potentially reducing exercise tolerance and leading to DOE (dyspnea on exertion), which could explain reports of low physical activity and fitness levels in obese children. The investigators propose that most of the respiratory effects in obese children are the result of low lung volume breathing, i.e., a reduction in functional residual capacity (FRC) at rest, and end-expiratory lung volume (EELV) during exercise.
The overall objective of this application is to investigate the respiratory effects of obesity in prepubescent children, including obese children with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with normal weight children before and after 1 yr. The investigative approach will be to examine respiratory function, exercise tolerance, and dyspnea on exertion (DOE) in prepubescent obese boys and girls, including those misdiagnosed with asthma (i.e., asthma not confirmed by lung function tests), before and after 1) weight loss (or an equivalent reduction in BMI percentile) and regular exercise and 2) continued weight gain (or an increase in BMI percentile) as compared with prepubescent normal weight boys and girls before and after a control period of 1 yr.
Specific Aims: The following hypotheses will be tested in obese children as compared with normal weight children:
Aim 1) Obesity will decrease respiratory function but to a greater extent in obese children misdiagnosed with asthma as evidenced by altered pulmonary function and breathing mechanics at rest; Aim 2) Obesity will decrease exercise tolerance (as evidenced by peak maximum oxygen uptake (VO2) in ml/min/kg, i.e., physical fitness), but not cardiorespiratory fitness (as evidenced by peak VO2 in % of predicted based on ideal body wt), except in obese children misdiagnosed with asthma where both may be reduced during graded cycle ergometry; Aim 3) Obesity will increase DOE but to a greater extent in obese children misdiagnosed with asthma as evidenced by increased ratings of perceived breathlessness during constant load exercise cycling; and Aim 4) Weight loss and regular exercise will improve respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, while continued weight gain will worsen respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, as compared with normal weight children before and after 1 yr.
The long-term objective is to investigate the effects of obesity on respiratory function, exercise tolerance, and DOE, examine obesity-related respiratory symptoms misdiagnosed as asthma in obese children, and provide novel results that could alter interventional approaches for preventing obesity and treating obesity in obese children. Thus, these results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma.
- Conditions
- Childhood Obesity
- Being tested
- 1 year follow-up testing
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 year follow-up testingOther
The approach of the study is not in studying the effectiveness of the intervention stimulus, the dose response of diet and exercise, or the rate of weight loss but only the response to 1) weight loss and regular exercise or 2) continued weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Obese Boys | Obese boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile. Receives: Other: 1 year follow-up testing | |
| Obese Girls | Obese girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile. Receives: Other: 1 year follow-up testing | |
| Normal Weight Boys | Normal weight boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI between 16th and 84th percentile. Receives: Other: 1 year follow-up testing | |
| Normal Weight Girls | Normal weight girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI between 16th and 84th percentile. Receives: Other: 1 year follow-up testing | |
| Obese Boys Misdiagnosed with Asthma | Obese boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile.This group will have a prior diagnosis of asthma without confirmation by lung function testing.The absence of asthma will be confirmed by a negative response (<10% increase in FEV1) to spirometry before and after bronchodilator (and on visit 2 by a negative bronchial challenge test [<10% decrease in FEV1]; i.e., EVH). Receives: Other: 1 year follow-up testing | |
| Obese Girls Misdiagnosed with Asthma | Obese girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile.This group will have a prior diagnosis of asthma without confirmation by lung function testing.The absence of asthma will be confirmed by a negative response (<10% increase in FEV1) to spirometry before and after bronchodilator (and on visit 2 by a negative bronchial challenge test [<10% decrease in FEV1]; i.e., EVH). Receives: Other: 1 year follow-up testing |
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 difference between nonobese and obese children at 1 yr
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 differences between nonobese and obese children at 1 yr
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 differences between nonobese and obese children at 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start26 Apr 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT03376880
- Sponsor's protocol ID
- STU 052012-076
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effects of Obesity in Children
- ClinicalTrials.gov ID
- NCT03376880
- Acronym / sponsor ID
- STU 052012-076
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Dec 2017 (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.
In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory system, particularly during exercise; however, it is unclear if this burden reduces exercise tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be misdiagnosed as asthma, placing obese children at risk of unnecessary treatment and potentially a reluctance to exercise explaining reports of low physical activity and fitness levels, which are counterproductive to weight loss. The investigators will examine the respiratory effects of obesity in prepubescent boys and girls, including those with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with prepubescent normal weight boys and girls before and after 1 year. These results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma, and the results could alter interventional approaches for preventing and treating childhood obesity.
Detailed description
In obese children, excess fat exerts an unfavorable burden on the respiratory system, particularly during exercise, potentially reducing exercise tolerance and leading to DOE (dyspnea on exertion), which could explain reports of low physical activity and fitness levels in obese children. The investigators propose that most of the respiratory effects in obese children are the result of low lung volume breathing, i.e., a reduction in functional residual capacity (FRC) at rest, and end-expiratory lung volume (EELV) during exercise.
The overall objective of this application is to investigate the respiratory effects of obesity in prepubescent children, including obese children with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with normal weight children before and after 1 yr. The investigative approach will be to examine respiratory function, exercise tolerance, and dyspnea on exertion (DOE) in prepubescent obese boys and girls, including those misdiagnosed with asthma (i.e., asthma not confirmed by lung function tests), before and after 1) weight loss (or an equivalent reduction in BMI percentile) and regular exercise and 2) continued weight gain (or an increase in BMI percentile) as compared with prepubescent normal weight boys and girls before and after a control period of 1 yr.
Specific Aims: The following hypotheses will be tested in obese children as compared with normal weight children:
Aim 1) Obesity will decrease respiratory function but to a greater extent in obese children misdiagnosed with asthma as evidenced by altered pulmonary function and breathing mechanics at rest; Aim 2) Obesity will decrease exercise tolerance (as evidenced by peak maximum oxygen uptake (VO2) in ml/min/kg, i.e., physical fitness), but not cardiorespiratory fitness (as evidenced by peak VO2 in % of predicted based on ideal body wt), except in obese children misdiagnosed with asthma where both may be reduced during graded cycle ergometry; Aim 3) Obesity will increase DOE but to a greater extent in obese children misdiagnosed with asthma as evidenced by increased ratings of perceived breathlessness during constant load exercise cycling; and Aim 4) Weight loss and regular exercise will improve respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, while continued weight gain will worsen respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, as compared with normal weight children before and after 1 yr.
The long-term objective is to investigate the effects of obesity on respiratory function, exercise tolerance, and DOE, examine obesity-related respiratory symptoms misdiagnosed as asthma in obese children, and provide novel results that could alter interventional approaches for preventing obesity and treating obesity in obese children. Thus, these results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Obese Boys | – | Other: 1 year follow-up testingObese boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile. |
| Obese Girls | – | Other: 1 year follow-up testingObese girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile. |
| Normal Weight Boys | – | Other: 1 year follow-up testingNormal weight boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI between 16th and 84th percentile. |
| Normal Weight Girls | – | Other: 1 year follow-up testingNormal weight girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI between 16th and 84th percentile. |
| Obese Boys Misdiagnosed with Asthma | – | Other: 1 year follow-up testingObese boys group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile.This group will have a prior diagnosis of asthma without confirmation by lung function testing.The absence of asthma will be confirmed by a negative response (<10% increase in FEV1) to spirometry before and after bronchodilator (and on visit 2 by a negative bronchial challenge test [<10% decrease in FEV1]; i.e., EVH). |
| Obese Girls Misdiagnosed with Asthma | – | Other: 1 year follow-up testingObese girls group defined by a Tanner score ≤ 3 in 8-12 yr olds with a BMI > 95th percentile, which will be expressed as a percentage above the 95th percentile < 150% of the 95th percentile.This group will have a prior diagnosis of asthma without confirmation by lung function testing.The absence of asthma will be confirmed by a negative response (<10% increase in FEV1) to spirometry before and after bronchodilator (and on visit 2 by a negative bronchial challenge test [<10% decrease in FEV1]; i.e., EVH). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants included in the study will be prepubescent boys and girls aged 8-12 yr old of all racial and ethnic origins with a Tanner Pubertal Stage of ≤ 3, and the ability to perform pulmonary function and exercise test accurately.
Key inclusion criteria (1 listed)
- Otherwise healthy with normal lung function; prepubescent (Tanner equal to or less than 3); age and gender specific BMI > 95th percentile, but less than 150% of the 95th percentile based on the CDC standards or age and gender specific BMI between the 16th and 84th percentile based on the Center for Disease Control (CDC) standards; and ability to perform pulmonary and exercise test accurately.
Key exclusion criteria (1 listed)
- Children with significant diseases other than obesity or shortness of breath on exertion will be excluded. Subjects participating in regular conditioning-type vigorous exercise two times or more per week will be excluded (i.e., sports training). Children 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 child.
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 |
|---|---|---|
| 1 year follow-up testingThe approach of the study is not in studying the effectiveness of the intervention stimulus, the dose response of diet and exercise, or the rate of weight loss but only the response to 1) weight loss and regular exercise or 2) continued weight gain. | Other | Normal Weight Boys, Normal Weight Girls, Obese Boys, Obese Boys Misdiagnosed with Asthma, Obese Girls, Obese Girls Misdiagnosed with Asthma |
Primary outcome
Pulmonary Function: Lung Volumes
Time frame: Change from Baseline in difference between nonobese and obese children at 1 yr
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 differences between nonobese and obese children at 1 yr
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 differences between nonobese and obese children at 1 yr
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 difference between nonobese and obese children at 1 yr). 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 19 Sep 2024.