Pilot of Lifestyle and Asthma Intervention

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.

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Key information

Conditions

Asthma Body Weight Body Weight Changes Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight loss intervention

Behavioral

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.

Primary outcomes

Weight Loss

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
University of Arizona
University of Vermont

Registry information

Acronym: PLAN

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Sep 25, 2017
Registry last updated: Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed