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Asthma and Obesity: Pilot Study

Primary Purpose

Asthma, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Better asthma self-management and incorporation of physical activity
Asthma Education
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Asthma, Obesity, Self-management behaviors

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver, Anschutz Medical Campus
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Asthma and Exercise Lifestyle Change

Asthma Education

Arm Description

Participants receive asthma and lifestyle change education related to exercise

No lifestyle change education

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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.
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.
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.
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.

Full Information

First Posted
October 1, 2019
Last Updated
October 19, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04113746
Brief Title
Asthma and Obesity: Pilot Study
Official Title
Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity
Keywords
Asthma, Obesity, Self-management behaviors

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The Research Coordinator who is administering the follow-up survey will be masked
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma and Exercise Lifestyle Change
Arm Type
Experimental
Arm Description
Participants receive asthma and lifestyle change education related to exercise
Arm Title
Asthma Education
Arm Type
Placebo Comparator
Arm Description
No lifestyle change education
Intervention Type
Behavioral
Intervention Name(s)
Better asthma self-management and incorporation of physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beliefs About Illness Perception Questionnaire (BIPQ)
Description
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
Secondary Outcome Measure Information:
Title
Medication Adherence Rating Scale (MARS)
Description
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
Title
Physical Activity - Step Counts Per Day
Description
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
Title
Time in Physical Activity
Description
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
Title
Asthma Control Questionnaire (ACQ)
Description
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
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
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
Title
Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P. Wisnivesky, MD, DrPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex D. Federman, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Holguin, MD, MPH
Organizational Affiliation
University of Colorado Denver, Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Asthma and Obesity: Pilot Study

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