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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL129198 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese asthmatic patients | Observational Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume (FEV1) | 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) | 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. | 18 months |
| Asthma Control Questionnaire (ACQ) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Controller Medication Adherence | 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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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Serum and plasma
| 4 weeks |
| The Medication Adherence Rating Scale (MARS) | 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). | 18 months |
| Food Behavior Checklist | 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. | 18 months |
| Physical activity level | 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. | 18 months |
| New York |
| New York |
| 10029 |
| United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |