Respiratory Effects of Obesity in Children

NCT03376880 | Completed

• 1 other identifier: STU 052012-076
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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.

  Change from Baseline differences between nonobese and obese children at 1 yr

Other Outcomes (5)

• Pulmonary Function: Spirometry

  Change from Baseline differences between nonobese and obese children at 1 yr

• Pulmonary Function: Diffusing Capacity

  Change from Baseline differences between nonobese and obese children at 1 yr

• Exercise Tolerance: Work Rate

  Change from Baseline differences between nonobese and obese children at 1 yr

Study Arms (6)

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.

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.

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.

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.

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).

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).

Other: 1 year follow-up testing

Interventions

1 year follow-up testing OTHER

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.

Normal Weight Boys; Normal Weight Girls; Obese Boys; Obese Boys Misdiagnosed with Asthma; Obese Girls; Obese Girls Misdiagnosed with Asthma

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Institute for Exercise and Environmental Medicine, UT Southwestern and Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tony G Babb, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: December 19, 2017
• Study Start: April 26, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)