AsthmaNCT04113746
Asthma and Obesity: Pilot Study
A study testing Better asthma self-management and incorporation of physical activity and Asthma Education in people with Asthma and Obesity, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- What is being tested?
- Better asthma self-management and incorporation of physical activity and Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2019to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 21-64 years of age
- BMI ≥ 30
- Asthma diagnosis made by a health care provider
- Poor Asthma Control (ACQ score ≥ 0.75)
- English speaking
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
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.
Read the 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.
- Being tested
- Better asthma self-management and incorporation of physical activity, Asthma Education
- Keywords
- Asthma, Obesity, Self-management behaviors
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better asthma self-management and incorporation of physical activityBehavioural
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.
Asthma EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Asthma and Exercise Lifestyle Change | Experimental | Participants receive asthma and lifestyle change education related to exercise Receives: Behavioral: Better asthma self-management and incorporation of physical activity |
| Asthma Education | Placebo comparator | No lifestyle change education Receives: Behavioral: Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 30 days Post-pilot follow-up visit, up to 2 months
Secondary outcomes (6)
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.
Measured: At 30 days Post-pilot follow-up visit, up to 2 months
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.
Measured: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
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.
Measured: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
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.
Measured: at 30 days Post-pilot follow-up visit, up to 2 months
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.
Measured: at 30 days post-pilot follow-up visit, up to 2 months
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.
Measured: at 30 days post pilot follow-up visit, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start3 Oct 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan P. Wisnivesky, MD, DrPH, Principal investigator, Icahn School of Medicine at Mount SinaiAlex D. Federman, MD, MPH, Principal investigator, Icahn School of Medicine at Mount SinaiFernando Holguin, MD, MPH, Principal investigator, University of Colorado Denver, Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113746
- Sponsor's protocol ID
- GCO 14-1859 I
- Other IDs
- R01HL129198
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2019
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
- ClinicalTrials.gov ID
- NCT04113746
- Acronym / sponsor ID
- GCO 14-1859 I
- Keywords
- Asthma, Obesity, Self-management behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma and Exercise Lifestyle Change | Experimental | Behavioral: Better asthma self-management and incorporation of physical activityParticipants receive asthma and lifestyle change education related to exercise |
| Asthma Education | Placebo comparator | Behavioral: Asthma EducationNo lifestyle change education |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 21-64 years of age
- BMI ≥ 30
- Asthma diagnosis made by a health care provider
- Poor Asthma Control (ACQ score ≥ 0.75)
- English speaking
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Better asthma self-management and incorporation of physical activityParticipants 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. | Behavioural | Asthma and Exercise Lifestyle Change |
| Asthma EducationGeneral 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. | Behavioural | Asthma Education |
Primary outcome
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.
6 secondary outcomes
Medication Adherence Rating Scale (MARS)
Time frame: 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
Time in Physical Activity
Time frame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
Asthma Control Questionnaire (ACQ)
Time frame: 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
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
Time frame: at 30 days post pilot follow-up visit, up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P. Wisnivesky, MD, DrPH principal investigator
Icahn School of Medicine at Mount Sinai
Alex D. Federman, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
Fernando Holguin, MD, MPH principal investigator
University of Colorado Denver, Anschutz Medical Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better asthma self-management and incorporation of physical activity and Asthma Education in people with Asthma and Obesity, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs About Illness Perception Questionnaire (BIPQ) (time frame: At 30 days Post-pilot follow-up visit, up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.