Pilot of Lifestyle and Asthma Intervention — PLAN  

Asthma Clinical Trial

Official title: Pilot of Lifestyle and Asthma Intervention

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT03291808
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Completion date: May 31, 2020