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Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03836547
Recruitment Status : Enrolling by invitation
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Disease Specific Quality of Life [ Time Frame: 8 weeks ]
    Chronic Respiratory questionnaire
  • Body Composition [ Time Frame: 8 weeks ]
    Impedance scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Official Title  ICMJE Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Brief Summary Researchers are trying to see if a multicomponent intervention to support weight loss decreases dyspnea in obese people with lung disease.
Detailed Description Patient will use the Weight watchers lifestyle program and receive health coaching
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Patients with lung disease and a BMI of 35 or greater with significant shortness of breath will receive health coaching for 8 weeks while using a weight loss app.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • COPD
  • Emphysema
  • Lung Diseases
Intervention  ICMJE Behavioral: Coaching and Weight Loss for patients with dyspnea
Patients with lung disease and a BMI of 35 or greater who suffer from shortness of breath will be invited to participate in a study involving a commercial weight loss application with health coaching. The patients will subscribe on their own to the weight loss application. The patients will be provided with a blue tooth scale so that they may weigh themselves weekly. A health coach will call them weekly for 8 weeks.
Study Arms  ICMJE Coaching and Weight loss
Coaching and Weight Loss for patients with dyspnea
Intervention: Behavioral: Coaching and Weight Loss for patients with dyspnea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age ≥ 18 years.
  • BMI >=35
  • Dyspnea MRC class II or greater
  • Diagnosis of lung disease
  • Signed informed consent

Exclusion Criteria

  • BMI <35
  • Pregnancy
  • Recent respiratory illness (within the last 6 weeks)
  • Recent exacerbation of chronic lung disease (within the last 6 weeks)
  • Already participating in a structured diet and/or exercise program
  • Medical contraindication to weight loss (cancer)
  • Medical contraindication to unsupervised exercise (unstable angina)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03836547
Other Study ID Numbers  ICMJE 18-001832
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberto P. Benzo, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto P Benzo Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP