Clinical trial NCT03460834: Asthma and Obesity: Observational
Official title: Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Obesity
Keywords: Asthma
Obesity
Observational Study
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-09
Enrollment: 333
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume (FEV1)
timeFrame: 18 months
measure: Exhaled Nitric Oxide (eNO)
timeFrame: 18 months
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 18 months
Secondary outcomes:
measure: Asthma Controller Medication Adherence
timeFrame: 4 weeks
measure: The Medication Adherence Rating Scale (MARS)
timeFrame: 18 months
measure: Food Behavior Checklist
timeFrame: 18 months
measure: Physical activity level
timeFrame: 18 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan P. Wisnivesky, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Alex D. Federman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver, Anschutz Medical Campus
name: Fernando Holguin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: