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Asthma and Obesity: Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113746
Recruitment Status : Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai

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
Asthma Obesity Behavioral: Better asthma self-management and incorporation of physical activity Behavioral: Asthma Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Research Coordinator who is administering the follow-up survey will be masked
Primary Purpose: Health Services Research
Official Title: Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Beliefs about Illness Perception Questionnaire (BIPQ) [ Time Frame: 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 :
  1. Change in Medication Adherence Rating Scale (MARS) [ Time Frame: 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.

  2. Changes in Physical Activity [ Time Frame: 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

  3. Change in Asthma Control Questionnaire (ACQ) [ Time Frame: 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

  4. Change in Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113746


Locations
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United States, Colorado
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, New York
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
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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

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Responsible Party: Juan P Wisnivesky, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04113746    
Other Study ID Numbers: GCO 14-1859 I
R01HL129198 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai:
Asthma
Obesity
Self-management behaviors
Additional relevant MeSH terms:
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Asthma
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases