Asthma and Obesity: Observational

NCT ID: NCT03460834

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2021-04-30

Brief Summary

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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

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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

Conditions

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Asthma Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese asthmatic patients

Observational Cohort

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Juan P Wisnivesky

Professor of Medicine and Chief, Division of General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan P. Wisnivesky, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Alex D. Federman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Fernando Holguin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver, Anschutz Medical Campus

Locations

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University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL129198

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 14-1859 O

Identifier Type: -

Identifier Source: org_study_id

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