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Pilot of Lifestyle and Asthma Intervention (PLAN)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Obesity, Asthma, Weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona
  • University of Vermont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight loss intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2017
Last Updated
August 26, 2022
Sponsor
Johns Hopkins University
Collaborators
American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Vermont, University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03291808
Brief Title
Pilot of Lifestyle and Asthma Intervention
Acronym
PLAN
Official Title
Pilot of Lifestyle and Asthma Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Vermont, University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Obesity, Asthma, Weight loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight loss intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss intervention
Intervention Description
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 Measure Information:
Title
Weight Loss
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Dixon, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Wise, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Holbrook, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35304842
Citation
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.
Results Reference
derived
Links:
URL
http://medlineplus.gov/asthma.html
Description
Related Info

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Pilot of Lifestyle and Asthma Intervention

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