Asthma and Obesity: Pilot Study
Study Details
Study Description
Brief Summary
Develop and pilot test four theory-based educational modules that integrate counseling for asthma and obesity to promote greater physical activity among people with asthma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Of the 400 obese and non-obese adult asthmatics in New York City and Denver during the 18-month observational phase of this study, the study team will randomize 80 participants (40 in NYC and 40 in Denver) into a 4-week group session pilot study focused on beliefs and behaviors associated with asthma and obesity self-management behaviors (SMB). Eligibility will be determined based on Asthma Control Questionnaire (ACQ) score and body mass index (BMI) at their 12-month visit. Participants will be randomized into an intervention or an active control arm after completing their 18-month visit. Participants will be consented into the pilot study during or after their 18-month visit. Participants will be put into groups of 7-10 for the pilot. Once formed, groups will have four 1-hour weekly visits. A person will be allowed to make up one missed session. The make-up session will be conducted on the phone or in-person depending on scheduling availability of both participant and care coach. Participants will be given accelerometers at sessions 1 and 4 that they will be asked to wear for seven days and return along with an activity diary. A follow-up survey will be administered about 30 days after the last pilot session in order to reassess the patient's asthma, obesity, exercise and medication beliefs and their adherence to asthma SMB. At the time of the follow-up survey, participants will also be given accelerometers that they will be asked to wear for seven days and return along with an activity diary.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Beliefs about Illness Perception Questionnaire (BIPQ) [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.
Secondary Outcome Measures
- Change in Medication Adherence Rating Scale (MARS) [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 [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) [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) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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21-64 years of age
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BMI ≥ 30
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Asthma diagnosis made by a health care provider
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Poor Asthma Control (ACQ score ≥ 0.75)
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English speaking
Exclusion Criteria:
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BMI < 30
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Good asthma control (ACQ score <0.75)
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Diagnosis of dementia
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Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness
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Smoking history of ≥15 pack-years owing to possible undiagnosed COPD
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.- GCO 14-1859 I
- R01HL129198