Pilot of Lifestyle and Asthma Intervention

NCT ID: NCT03291808

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2020-05-31

Brief 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.

Detailed 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

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Weight loss intervention

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.

Group Type: EXPERIMENTAL

Weight loss intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Robert Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Janet Holbrook, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

University of Arizona

Tucson, Arizona, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

Johnson O, Gerald LB, Harvey J, Roy G, Hazucha H, Large C, Burke A, McCormack M, Wise RA, Holbrook JT, Dixon AE. An Online Weight Loss Intervention for People With Obesity and Poorly Controlled Asthma. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1577-1586.e3. doi: 10.1016/j.jaip.2022.02.040. Epub 2022 Mar 15.

Reference Type: DERIVED

PMID: 35304842 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://medlineplus.gov/asthma.html

Related Info

Other Identifiers

R34HL136755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00141509

Identifier Type: -

Identifier Source: org_study_id