- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460834
Asthma and Obesity: Observational
May 4, 2021 updated by: Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai
Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
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.
Study Overview
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:
- 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.
- Evaluate the interrelationship between obesity- and asthma-related illness beliefs, and the impact of cognitive function, on patients' management of these conditions over time
Study Type
Observational
Enrollment (Anticipated)
333
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver, Anschutz Medical Campus
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Obese asthmatic patients
Observational Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory volume (FEV1)
Time Frame: 18 months
|
Forced expiratory volume (FEV1) measures how much air a person can exhale during the first second of a forced breath, performed by spirometry.
|
18 months
|
Exhaled Nitric Oxide (eNO)
Time Frame: 18 months
|
eNO is the most widely used and standardized noninvasive biomarker that evaluates airway inflammation in asthma.
measured before spirometry using the NIOX MINO system (Aerocrine AB, Stockholm, Sweden) following established procedures.
Current guidelines do not yet specify ''normal'' values; however, eNO levels >20-25ppb have been used as cut-points indicating airway inflammation and the need to change treatment.
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18 months
|
Asthma Control Questionnaire (ACQ)
Time Frame: 18 months
|
The ACQ has 7 items: 5 items-self administered for symptoms, 1 item self administered rescue inbronchodilator use, and 1 item FEV1% completed by provider.
7-point scale from 0 = no impairment to 6 = maximum impairment.
The questions are equally weighted and the ACQ score is the mean of the 7 questions, with total score range between 0 (totally controlled) and 6 (severely uncontrolled).
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Controller Medication Adherence
Time Frame: 4 weeks
|
objectively measure ICS adherence using the Smartinhaler (Nexus6, Franklin, OH) or Doser electronic devices (Meditrack, MA) for metered dose inhalers (MDIs) and the Smartdisk (Nexus6, Franklin, OH) for dry powder inhalers (DPIs) for 4 weeks after each in-person interview.
Adherence will be defined as use of medications on ≥80% of days prescribed, a commonly applied convention.
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4 weeks
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The Medication Adherence Rating Scale (MARS)
Time Frame: 18 months
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A 10-item self-reported questionnaire resulting from the combination of the Medication Adherence Questionnaire and the Drug Attitude Inventory.
The MARS contains 10 yes/no item and the sum of items yields a final score ranking from 0 (poor adherence to treatment) to 10 (good adherence to treatment).
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18 months
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Food Behavior Checklist
Time Frame: 18 months
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16 question survey.
Each question represents a certain value (1 - 4) that when added collectively predicts the quality of person's food consumption habits.
The higher the score, the more optimal the habits.
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18 months
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Physical activity level
Time Frame: 18 months
|
Physical activity: levels will be assessed using an ActiGraph wGT3X-BL triaxial accelerometer (ActiGraph LLC; Pensacola, FL) worn on the waist for 7 days after each in person visit.
The ActiGraph has been validated for physical activity and sedentary time in laboratory and field settings.
Data from the monitor will be output as activity counts then converted to step counts and time spent in different intensities of activity using previously determined cut-points.
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18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan P. Wisnivesky, MD, DrPH, Icahn School of Medicine at Mount Sinai
- Principal Investigator: Alex D. Federman, MD, MPH, Icahn School of Medicine at Mount Sinai
- Principal Investigator: Fernando Holguin, MD, MPH, University of Colorado Denver, Anschutz Medical Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
March 2, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 4, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 14-1859 O
- R01HL129198 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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