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Pilot of Lifestyle and Asthma Intervention (PLAN)

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ClinicalTrials.gov Identifier: NCT03291808
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
University of Vermont
University of Arizona
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Weight loss intervention Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot of Lifestyle and Asthma Intervention
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291808


Contacts
Contact: Gem Roy, MD 4432875796 groy2@jhu.edu
Contact: Joy Saams, RN 4105029145 jsaams1@jhu.edu

Locations
United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Lynn Gerald, PhD       lgerald@email.arizona.edu   
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Anne Dixon, MD       Anne.Dixon@uvmhealth.org   
Sponsors and Collaborators
Johns Hopkins University
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
University of Vermont
University of Arizona
Investigators
Principal Investigator: 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

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03291808     History of Changes
Other Study ID Numbers: IRB00141509
R34HL136755 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Obesity; asthma; Weight loss

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases