Pilot of Lifestyle and Asthma Intervention

Study Overview
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Brief Summary
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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 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. The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.

Detailed Description
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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

Official Title
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Pilot of Lifestyle and Asthma Intervention

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Weight loss intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss intervention<br>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).18 Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. | Behavioral: Weight loss intervention<br>* This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly group meetings in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Asthma, Weight loss