Status:
COMPLETED
Pilot of Lifestyle and Asthma Intervention
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is to pilot test a weight loss intervention in obese patients with poorly controlled asthma. Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year of asthm...
Detailed Description
This will be a pilot study of a weight loss intervention at two centers, the University of Arizona and the University of Vermont. The primary outcome of interest will be the percent of participants ac...
Eligibility Criteria
Inclusion
- Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
- Age: ≥18 years of age
- Obese: BMI \> 30 kg/m2
- Poorly controlled asthma
- Asthma Control Test Score \< 19,19,20 or
- Use of rescue inhaler, on average, \> 2 uses/week for preceding month, or
- Nocturnal asthma awakening, on average,1 or more times / week in preceding month, or
- Emergency Department (ED)/hospital visit or prednisone course for asthma in past six months
- Ability and willingness to provide informed consent
- Ability to access internet weight loss program for trial period
- Completion of asthma diary cards and weight loss diary cards for same 3 consecutive days at visit 2
Exclusion
- Prior history of bariatric surgery
- Any condition that puts the participant at risk from participation in a weight loss study or a condition that precludes participation in regular exercise as judged by the site physician.
- Pregnancy (by patient self-report)
- Participation in another weight loss intervention within the last month
- Weight loss of ≥ 10 pounds in the last 6 months by self-report
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03291808
Start Date
November 15 2017
End Date
May 31 2020
Last Update
September 21 2022
Active Locations (2)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of Vermont
Burlington, Vermont, United States, 05401