Asthma, Obesity
Conditions
Keywords
Asthma, Obesity, Self-management behaviors
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.
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.
Interventions
BEHAVIORALBetter 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.
BEHAVIORALAsthma 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.
Sponsors
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The Research Coordinator who is administering the follow-up survey will be masked
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beliefs About Illness Perception Questionnaire (BIPQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity - Step Counts Per Day | 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 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. |
| Time in Physical Activity | 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. |
| Medication Adherence Rating Scale (MARS) | 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. |
| Asthma Quality of Life Questionnaire (AQLQ) | 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. |
| Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale | 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. |
| Asthma Control Questionnaire (ACQ) | at 30 days Post-pilot follow-up visit, up to 2 months | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Asthma and Exercise Lifestyle Change | Asthma Education | Total |
|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 10.7 | 48.7 years STANDARD_DEVIATION 14.8 | 48 years STANDARD_DEVIATION 12.7 |
| Body Mass Index (BMI) | 37 kg/m^2 STANDARD_DEVIATION 6.5 | 39.6 kg/m^2 STANDARD_DEVIATION 8.7 | 38.2 kg/m^2 STANDARD_DEVIATION 7.5 |
| Education Any College | 5 Participants | 4 Participants | 9 Participants |
| Education Any High School | 0 Participants | 2 Participants | 2 Participants |
| Education College Graduate | 3 Participants | 5 Participants | 8 Participants |
| Education Elementary | 0 Participants | 1 Participants | 1 Participants |
| Education Higher Degree | 0 Participants | 1 Participants | 1 Participants |
| Education High School Graduate | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Insurance Medicaid | 7 Participants | 6 Participants | 13 Participants |
| Insurance Medicare | 1 Participants | 0 Participants | 1 Participants |
| Insurance Medicare and Medicaid | 0 Participants | 1 Participants | 1 Participants |
| Insurance Missing | 3 Participants | 4 Participants | 7 Participants |
| Insurance Private | 2 Participants | 3 Participants | 5 Participants |
| Language English | 12 Participants | 12 Participants | 24 Participants |
| Language Spanish | 1 Participants | 2 Participants | 3 Participants |
| Marital Status Married | 3 Participants | 7 Participants | 10 Participants |
| Marital Status Unmarried | 10 Participants | 7 Participants | 17 Participants |
| Monthly Income Less than $3000 | 9 Participants | 10 Participants | 19 Participants |
| Monthly Income Missing/refused | 2 Participants | 2 Participants | 4 Participants |
| Monthly Income More than $3000 | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Beliefs About Illness Perception Questionnaire (BIPQ)
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.
Time frame: At 30 days Post-pilot follow-up visit, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Beliefs About Illness Perception Questionnaire (BIPQ) | 42.6 score on a scale | Standard Deviation 11.4 |
| Asthma Education | Beliefs About Illness Perception Questionnaire (BIPQ) | 36.2 score on a scale | Standard Deviation 8.2 |
Secondary
Asthma Control Questionnaire (ACQ)
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.
Time frame: at 30 days Post-pilot follow-up visit, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Asthma Control Questionnaire (ACQ) | 1.6 score on a scale | Standard Deviation 1 |
| Asthma Education | Asthma Control Questionnaire (ACQ) | 1.3 score on a scale | Standard Deviation 0.9 |
Secondary
Asthma Quality of Life Questionnaire (AQLQ)
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.
Time frame: at 30 days post-pilot follow-up visit, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Asthma Quality of Life Questionnaire (AQLQ) | 4.9 score on a scale | Standard Deviation 0.8 |
| Asthma Education | Asthma Quality of Life Questionnaire (AQLQ) | 5.0 score on a scale | Standard Deviation 0.6 |
Secondary
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
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.
Time frame: at 30 days post pilot follow-up visit, up to 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale | Necessity Subscale | 15 score on a scale | Standard Deviation 3.6 |
| Asthma and Exercise Lifestyle Change | Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale | Concerns Subscale | 8.4 score on a scale | Standard Deviation 1 |
| Asthma Education | Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale | Necessity Subscale | 16.4 score on a scale | Standard Deviation 5 |
| Asthma Education | Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale | Concerns Subscale | 8.4 score on a scale | Standard Deviation 2.7 |
Secondary
Medication Adherence Rating Scale (MARS)
MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.
Time frame: At 30 days Post-pilot follow-up visit, up to 2 months
Population: Data only obtained from participants on a controller medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Medication Adherence Rating Scale (MARS) | 4.7 score on a scale | Standard Deviation 0.5 |
| Asthma Education | Medication Adherence Rating Scale (MARS) | 4.7 score on a scale | Standard Deviation 0.5 |
Secondary
Physical Activity - Step Counts Per Day
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.
Time frame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
Population: Data for participants with accelerometers with valid analyzable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Physical Activity - Step Counts Per Day | Week 2 | 12253.3 steps/day | Standard Deviation 0 |
| Asthma and Exercise Lifestyle Change | Physical Activity - Step Counts Per Day | Week 4 | 13730.2 steps/day | Standard Deviation 0 |
| Asthma and Exercise Lifestyle Change | Physical Activity - Step Counts Per Day | at 30 days post pilot follow-up visit | 2667.9 steps/day | Standard Deviation 375.4 |
| Asthma Education | Physical Activity - Step Counts Per Day | Week 2 | 2499.7 steps/day | Standard Deviation 1514.9 |
| Asthma Education | Physical Activity - Step Counts Per Day | Week 4 | 2123.9 steps/day | Standard Deviation 1751 |
| Asthma Education | Physical Activity - Step Counts Per Day | at 30 days post pilot follow-up visit | 3715.1 steps/day | Standard Deviation 3041.5 |
Secondary
Time in Physical Activity
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.
Time frame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
Population: Data for participants with accelerometers with valid analyzable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asthma and Exercise Lifestyle Change | Time in Physical Activity | Week 2 | 74.5 minutes/day | Standard Deviation 0 |
| Asthma and Exercise Lifestyle Change | Time in Physical Activity | Week 4 | 91.5 minutes/day | Standard Deviation 0 |
| Asthma and Exercise Lifestyle Change | Time in Physical Activity | at 30 days post pilot follow-up visit | 9.9 minutes/day | Standard Deviation 6.8 |
| Asthma Education | Time in Physical Activity | Week 2 | 8.6 minutes/day | Standard Deviation 7 |
| Asthma Education | Time in Physical Activity | Week 4 | 10.3 minutes/day | Standard Deviation 8.3 |
| Asthma Education | Time in Physical Activity | at 30 days post pilot follow-up visit | 7.8 minutes/day | Standard Deviation 9.2 |