Trial Outcomes & Findings for Asthma and Obesity: Pilot Study (NCT NCT04113746)
NCT ID: NCT04113746
Last Updated: 2022-11-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
At 30 days Post-pilot follow-up visit, up to 2 months
Results posted on
2022-11-14
Participant Flow
Recruitment began in May 2019 with enrollment from Oct 2019-April 2021 at Icahn School of Medicine at Mount Sinai and University of Colorado, Denver)
Participant milestones
| Measure |
Asthma and Exercise Lifestyle Change
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Asthma and Exercise Lifestyle Change
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Asthma and Obesity: Pilot Study
Baseline characteristics by cohort
| Measure |
Asthma and Exercise Lifestyle Change
n=13 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=14 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
48 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
37 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
39.6 kg/m^2
STANDARD_DEVIATION 8.7 • n=7 Participants
|
38.2 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Marital Status
Married
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital Status
Unmarried
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Language
English
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Language
Spanish
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Monthly Income
Less than $3000
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Monthly Income
More than $3000
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Monthly Income
Missing/refused
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
Elementary
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Any High School
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
High School Graduate
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
Any College
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
College Graduate
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
Higher Degree
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance
Medicare
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Insurance
Medicare and Medicaid
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance
Private
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Insurance
Missing
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 30 days Post-pilot follow-up visit, up to 2 monthsBIPQ 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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=9 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=10 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Beliefs About Illness Perception Questionnaire (BIPQ)
|
42.6 score on a scale
Standard Deviation 11.4
|
36.2 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: At 30 days Post-pilot follow-up visit, up to 2 monthsPopulation: Data only obtained from participants on a controller medication.
MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=7 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=9 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Medication Adherence Rating Scale (MARS)
|
4.7 score on a scale
Standard Deviation 0.5
|
4.7 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 2, Week 4, and at 30 days Post-pilot follow-up visitPopulation: Data for participants with accelerometers with valid analyzable data.
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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=3 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=4 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Physical Activity - Step Counts Per Day
Week 2
|
12253.3 steps/day
Standard Deviation 0
|
2499.7 steps/day
Standard Deviation 1514.9
|
|
Physical Activity - Step Counts Per Day
Week 4
|
13730.2 steps/day
Standard Deviation 0
|
2123.9 steps/day
Standard Deviation 1751.0
|
|
Physical Activity - Step Counts Per Day
at 30 days post pilot follow-up visit
|
2667.9 steps/day
Standard Deviation 375.4
|
3715.1 steps/day
Standard Deviation 3041.5
|
SECONDARY outcome
Timeframe: Week 2, Week 4, and at 30 days Post-pilot follow-up visitPopulation: Data for participants with accelerometers with valid analyzable data.
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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=5 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=6 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Time in Physical Activity
at 30 days post pilot follow-up visit
|
9.9 minutes/day
Standard Deviation 6.8
|
7.8 minutes/day
Standard Deviation 9.2
|
|
Time in Physical Activity
Week 2
|
74.5 minutes/day
Standard Deviation 0
|
8.6 minutes/day
Standard Deviation 7.0
|
|
Time in Physical Activity
Week 4
|
91.5 minutes/day
Standard Deviation 0
|
10.3 minutes/day
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: at 30 days Post-pilot follow-up visit, up to 2 monthsAsthma 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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=9 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=10 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
|
1.6 score on a scale
Standard Deviation 1.0
|
1.3 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: at 30 days post-pilot follow-up visit, up to 2 monthsAsthma 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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=9 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=10 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ)
|
4.9 score on a scale
Standard Deviation 0.8
|
5.0 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: at 30 days post pilot follow-up visit, up to 2 monthsBeliefs 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.
Outcome measures
| Measure |
Asthma and Exercise Lifestyle Change
n=9 Participants
Participants receive asthma and lifestyle change education related to exercise
Participants in the asthma and exercise lifestyle change arm participated 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 used the accelerometer to track activity, but was blinded to the data.
|
Asthma Education
n=10 Participants
No lifestyle change education
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 used the accelerometer to track activity, but was blinded to the data.
|
|---|---|---|
|
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
Necessity Subscale
|
15 score on a scale
Standard Deviation 3.6
|
16.4 score on a scale
Standard Deviation 5
|
|
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
Concerns Subscale
|
8.4 score on a scale
Standard Deviation 1
|
8.4 score on a scale
Standard Deviation 2.7
|
Adverse Events
Asthma and Exercise Lifestyle Change
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Juan P. Wisnivesky, MD, DrPH
Icahn School of Medicine at Mount Sinai
Phone: 212-824-7567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place