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

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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

Brief Summary:
Researchers are trying to see if a multicomponent intervention to support weight loss decreases dyspnea in obese people with lung disease.

Condition or disease Intervention/treatment Phase
COPD Emphysema Lung Diseases Behavioral: Coaching and Weight Loss for patients with dyspnea Not Applicable

Detailed Description:
Patient will use the Weight watchers lifestyle program and receive health coaching

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coaching and Weight loss
Coaching and Weight Loss for patients with dyspnea
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.




Primary Outcome Measures :
  1. Disease Specific Quality of Life [ Time Frame: 8 weeks ]
    Chronic Respiratory questionnaire

  2. Body Composition [ Time Frame: 8 weeks ]
    Impedance scale



Information from the National Library of Medicine

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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

  • 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)

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): NCT03836547


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roberto P Benzo Mayo Clinic

Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03836547     History of Changes
Other Study ID Numbers: 18-001832
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
Lung Diseases
Dyspnea
Emphysema
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes