N/A
Completed N=43
Pilot of Lifestyle and Asthma Intervention
Source: ClinicalTrials.gov NCT03291808 ↗Enrolled (actual)
43
Serious AEs
25.6%
Results posted
Sep 2022
Primary outcomePrimary: Weight Loss — 43 Participants — p=.35
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 asthma in the U.S. are related to obesity).
Investigators' ultimate purpose is to test the hypothesis that weight loss through an intensive life style intervention will improve asthma control. But investigators first need to establish whether the weight loss intervention is effective in patients with asthma.
Objectives
1. The primary objective of this study is to determine the effectiveness of an internet-based weight loss intervention in producing weight loss in obese patients with poorly controlled asthma.
2. The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss |
43 | .35 |
Eligibility Criteria
Inclusion Criteria
- 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 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03291808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.