Asthma and Obesity: Pilot Study
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|ClinicalTrials.gov Identifier: NCT04113746|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma Obesity||Behavioral: Better asthma self-management and incorporation of physical activity Behavioral: Asthma Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The Research Coordinator who is administering the follow-up survey will be masked|
|Primary Purpose:||Health Services Research|
|Official Title:||Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways|
|Actual Study Start Date :||October 3, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Asthma and Exercise Lifestyle Change
Participants receive asthma and lifestyle change education related to exercise
Behavioral: Better asthma self-management and incorporation of physical activity
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
Behavioral: Asthma 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.
- Change in Beliefs about Illness Perception Questionnaire (BIPQ) [ Time Frame: At 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit ]BIPQ includes 9 items for each of the 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). Items on the BIPQ are not meant to be summed, but rather evaluated and interpreted individually. Change at 12 weeks as compared to 4 weeks post-pilot follow-up visit.
- Change in Medication Adherence Rating Scale (MARS) [ Time Frame: At 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit ]MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence. Change at 12 weeks as compared to 4 weeks post-pilot follow-up visit.
- Changes in Physical Activity [ Time Frame: Week 2, Week 4, at 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit ]Physical activity monitoring using accelerometer and accompanying activity diary for self-report of wear. The accelerometer will measure step counts and 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 will be considered a valid measure of usual activity. Change at 12 weeks post-pilot as compared to week 2, week 4 and 4 weeks post-pilot follow up visit
- Change in Asthma Control Questionnaire (ACQ) [ Time Frame: Post-pilot follow-up visit ]Change in 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 12 weeks post-pilot follow up vist as compared to 4 weeks post-pilot follow-up visit
- Change in Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Post-pilot follow-up visit ]Change in self-reported asthma-related quality of life validated survey used to assess asthma-related quality of life at 12 weeks post-pilot follow-up visit as compared to 4 weeks post-pilot follow-up visit. Total Score from 1-7, with higher score indicating better quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113746
|United States, Colorado|
|University of Colorado Denver, Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|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|