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Asthma and Obesity: Observational

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Mount Sinai Health System

Status

Completed

Conditions

Asthma
Obesity

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03460834
R01HL129198 (U.S. NIH Grant/Contract)
GCO 14-1859 O

Details and patient eligibility

About

Obesity is associated with poor asthma control and greater healthcare utilization and costs. In this study the researchers will examine the biologic and behavioral interrelationships between these conditions and their impact on outcomes. Towards this end, the researchers will conduct an observational prospective cohort study of 400 obese asthmatic patients treated at institutions in New York City and Denver, and develop and pilot test educational and counseling modules that take an integrated approach to asthma and obesity self-management support.

Full description

The objective of this study is to examine novel biological and behavioral pathways that may explain the association of obesity with asthma morbidity, and develop and pilot test educational and counseling modules, based on self-regulation theory, that take an integrated approach to asthma and obesity self-management support.

The Specific Aims are to:

  1. Compare the longitudinal relationship between L-arginine/ADMA balance and morbidity (lung function, asthma control, acute resource utilization, and quality of life) between obese adults with late onset asthma vs. (a) obese adults with early onset asthma and non-obese asthmatics with early (b) or late (c) onset disease. Age of asthma onset is as categorized as early when developed ≤12 years of age or late when developed >12 years of age.
  2. Evaluate the interrelationship between obesity- and asthma-related illness beliefs, and the impact of cognitive function, on patients' management of these conditions over time

Enrollment

333 estimated patients

Sex

All

Ages

21 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >21 years with a diagnosis of asthma made by a health care provider and evidence of airway reactivity (increase in FEV1 >12% and >200 ml after bronchodilators or positive methacholine test) in prior lung function testing or baseline spirometry;
  • prescribed an asthma controller medication;
  • English or Spanish speaking.

Exclusion criteria

  • chronic obstructive lung disease (COPD) or other chronic respiratory illness; - >15 pack-year smoking history because of the possibility of undiagnosed COPD;
  • diagnosis of dementia identified in the clinical record.

Trial design

333 participants in 1 patient group

Obese asthmatic patients
Description:
Observational Cohort

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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