Pilot of Lifestyle and Asthma Intervention

NCT03291808 | Completed Results DMC

• 2 other identifiers: IRB00141509R34HL136755
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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

Conditions

Asthma

Keywords

Obesity; Asthma; Weight loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Weight loss intervention

EXPERIMENTAL

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

Interventions

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.

Weight loss intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Lung Association: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Vermont: collaborator
• University of Arizona: collaborator

Study Sites (2)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 35304842 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Asthma; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gem Roy
• Organization: Johns Hopkins University

groy2@jhu.edu

4432875796

Study Officials

• Anne Dixon, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Robert Wise, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

• Janet Holbrook, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: November 15, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)