Asthma and Obesity: Observational

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT03460834
Collaborator
University of Colorado, Denver (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
333
2
60
166.5
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    333 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Apr 30, 2021
    Actual Study Completion Date :
    Apr 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Obese asthmatic patients

    Observational Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Forced expiratory volume (FEV1) [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.

    2. Exhaled Nitric Oxide (eNO) [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.

    3. Asthma Control Questionnaire (ACQ) [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).

    Secondary Outcome Measures

    1. Asthma Controller Medication Adherence [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.

    2. The Medication Adherence Rating Scale (MARS) [18 months]

      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).

    3. Food Behavior Checklist [18 months]

      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.

    4. Physical activity level [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver, Anschutz Medical Campus Aurora Colorado United States 80045
    2 Icahn School of Medicine at Mount Sinai New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai
    • University of Colorado, Denver
    • National Heart, Lung, and Blood Institute (NHLBI)

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juan P Wisnivesky, Professor of Medicine and Chief, Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT03460834
    Other Study ID Numbers:
    • GCO 14-1859 O
    • R01HL129198
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Juan P Wisnivesky, Professor of Medicine and Chief, Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2021