- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113746
Asthma and Obesity: Pilot Study
Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver, Anschutz Medical Campus
-
-
New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 21-64 years of age
- BMI ≥ 30
- Asthma diagnosis made by a health care provider
- Poor Asthma Control (ACQ score ≥ 0.75)
- English speaking
Exclusion Criteria:
- BMI < 30
- Good asthma control (ACQ score <0.75)
- Diagnosis of dementia
- Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness
- Smoking history of ≥15 pack-years owing to possible undiagnosed COPD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asthma and Exercise Lifestyle Change
Participants receive asthma and lifestyle change education related to exercise
|
Participants in the asthma and exercise lifestyle change arm will participate in 4 sessions focused on behavioral change and goal-setting education to teach them how to better incorporate exercise into their daily lives and better manage their asthma.
Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
|
Placebo Comparator: Asthma Education
No lifestyle change education
|
General asthma education, but no discussion of the role of exercise and other lifestyle habits in asthma self-management.
Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beliefs About Illness Perception Questionnaire (BIPQ)
Time Frame: At 30 days Post-pilot follow-up visit, up to 2 months
|
BIPQ includes 5 cognitive domains (Identity, Cause, Timeline, Consequences, and Cure-Control) designed to rapidly assess the cognitive and emotional representations of illness.
Each item in each domain is scored on a 0 (none) to 10 (extreme).
Full scale from 0-80, where higher score reflects a more threatening view of the illness.
|
At 30 days Post-pilot follow-up visit, up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence Rating Scale (MARS)
Time Frame: At 30 days Post-pilot follow-up visit, up to 2 months
|
MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.
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At 30 days Post-pilot follow-up visit, up to 2 months
|
Physical Activity - Step Counts Per Day
Time Frame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
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Physical activity monitoring using accelerometer and accompanying activity diary for self-report of wear.
The accelerometer will measure step counts using previously determined cut-points.
Based on accepted methodology, 3 or more out of the 7 days with 10 or more hours of wear time will be considered a valid measure of usual activity.
|
Week 2, Week 4, and at 30 days Post-pilot follow-up visit
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Time in Physical Activity
Time Frame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
|
Physical activity monitoring using accelerometer and accompanying activity diary for self-report of wear.
The accelerometer measured time spent in different intensities of activity using previously determined cut-points.
Based on accepted methodology, 3 or more out of the 7 days with 10 or more hours of wear time was considered a valid measure of usual activity.
|
Week 2, Week 4, and at 30 days Post-pilot follow-up visit
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Asthma Control Questionnaire (ACQ)
Time Frame: at 30 days Post-pilot follow-up visit, up to 2 months
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Asthma Control Questionnaire (ACQ) - self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma, used to assess current asthma control at 30 days post-pilot follow up visit.
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at 30 days Post-pilot follow-up visit, up to 2 months
|
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: at 30 days post-pilot follow-up visit, up to 2 months
|
Asthma Quality of Life Questionnaire (AQLQ) - self-reported asthma-related quality of life validated survey used to assess asthma-related quality of life at 30 days post-pilot follow-up visit.
Total Score from 1-7, with higher score indicating better quality of life.
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at 30 days post-pilot follow-up visit, up to 2 months
|
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
Time Frame: at 30 days post pilot follow-up visit, up to 2 months
|
Beliefs about Medications Questionnaire (BMQ) - Necessity and Concerns The BMQ comprises two separate two five-item sub-scales (Necessity and Concerns) and assesses respondents' beliefs about prescribed medicines that they are currently using for specific conditions, for e.g. asthma. It assesses patients' beliefs about the necessity of prescribed medication for controlling their disease and their concerns about potential adverse consequences of taking it. Respondents indicate their degree of agreement with each statement on a five-point Likert scale, ranging from 1 - strongly disagree to 5 - strongly agree. Each subscale is scored from 5 -25. Scores obtained for individual items within both scales are summed. Thus, total scores for the Necessity and Concerns Scales range from 10-50. Higher scores indicate stronger beliefs in necessity or more concerns. |
at 30 days post pilot follow-up visit, up to 2 months
|
Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 14-1859 I
- R01HL129198 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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