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Completed

NCT Number: NCT03460834

Asthma and Obesity: Observational

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.

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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.

  2. The Medication Adherence Rating Scale (MARS)

    Time frame: 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

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Colorado, Denver

Registry information

Official study title

Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2018
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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