Pilot of Lifestyle and Asthma Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | November 15, 2017 |
| End Date: | April 2020 |
| Contact: | Gem Roy, MD |
| Email: | groy2@jhu.edu |
| Phone: | 4432875796 |
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.
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.
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 achieving a 5% weight loss, which is the amount of weight loss that prior
studies suggest is required to improve asthma control.
This will be a single arm-phase II futility trial; the "futility" to be assessed is the
ability to produce weight loss. Such designs are widely used in efficiently informing
decisions to proceed to Phase III clinical trials. This trial design is appropriate when the
effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to
0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to
weight loss). This is a 6-month study of 40 participants (20 at each site). All participants
will be assigned to the weight loss intervention, which is described in detail below
Arizona and the University of Vermont. The primary outcome of interest will be the percent of
participants achieving a 5% weight loss, which is the amount of weight loss that prior
studies suggest is required to improve asthma control.
This will be a single arm-phase II futility trial; the "futility" to be assessed is the
ability to produce weight loss. Such designs are widely used in efficiently informing
decisions to proceed to Phase III clinical trials. This trial design is appropriate when the
effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to
0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to
weight loss). This is a 6-month study of 40 participants (20 at each site). All participants
will be assigned to the weight loss intervention, which is described in detail below
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 < 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 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
We found this trial at
2
sites
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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