Pilot of Lifestyle and Asthma Intervention

Asthma Clinical Trial

— PLAN  

Official title:

Pilot of Lifestyle and Asthma Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291808
• Other study ID #: IRB00141509
• Secondary ID: R34HL136755
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Weight loss intervention
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.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	University of Arizona	Tucson	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Arizona, University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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