search
Back to results

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

Primary Purpose

COPD, Emphysema, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching and Weight Loss for patients with dyspnea
Active Control
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

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

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)

Sites / Locations

  • Mayo Clinic in Arizona
  • Mayo Clinic in Florida
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multicomponent Intervention for weight loss

Wait-list Control

Arm Description

12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.

The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.

Outcomes

Primary Outcome Measures

Breathlessness
Chronic Respiratory Questionnaire Dyspnea

Secondary Outcome Measures

Lean Body Mass (lbs.)using InBody 770 Scale
InBody770 analyzer to define Lean Body Mass (total body weight minus weight of fat). This measure includes organs, skin, bones, water and muscle.
Skeletal Muscle Mass (lbs.) using InBody 770 Scale
InBody770 analyzer to define skeletal muscle mass (total weight of muscle)
Percent Body Fat using InBody 770 Scale
InBody770 analyzer to define percent body fat
Weight using InBody 770 Scale
InBody770 analyzer to define weight
Body Mass Index using InBody 770 Scale
InBody770 analyzer to define Body Mass Index (BMI) is weight in kilograms divided by height in meters squared. A BMI of 25 or below is considered healthy.
Mindful Eating
Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.
Daily Steps
Number of steps participant takes in a day recorded by Actigraph Activity tracker.
Daily Sedentary Time
Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status
Daily Physical Activity
Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs
Exercise Capacity
Six-Minute Walking Test
Sleep Time Measures
Actigraph to measure total sleep time
Sleep Efficiency
Time sleeping/ Time reclined
Disease specific quality of life
Chronic Respiratory Questionnaire measures Fatigue , Emotions and Mastery and is a 20 item questionnaire with a range of 1-7. A higher score is best.

Full Information

First Posted
January 21, 2019
Last Updated
October 31, 2022
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03836547
Brief Title
Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Official Title
Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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

5. Study Description

Brief Summary
Researchers are trying to test the effectiveness and feasibility of a multicomponent lifestyle intervention to support weight loss decreases dyspnea in obese people with chronic lung disease and clinically significant breathlessness.
Detailed Description
Patient will be randomized to a 12-week intervention that uses the Weight watchers lifestyle program online, a Garmin Fitness Tracker, blue tooth scale and receive health coaching vs a wait-list control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema, Lung Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with lung disease and a BMI of 35 or greater with significant shortness of breath will be randomized to a multicomponent intervention vs a wait-list control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent Intervention for weight loss
Arm Type
Experimental
Arm Description
12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.
Arm Title
Wait-list Control
Arm Type
Active Comparator
Arm Description
The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.
Intervention Type
Behavioral
Intervention Name(s)
Coaching and Weight Loss for patients with dyspnea
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants will receive usual care for 12 weeks followed by the active intervention.
Primary Outcome Measure Information:
Title
Breathlessness
Description
Chronic Respiratory Questionnaire Dyspnea
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Lean Body Mass (lbs.)using InBody 770 Scale
Description
InBody770 analyzer to define Lean Body Mass (total body weight minus weight of fat). This measure includes organs, skin, bones, water and muscle.
Time Frame
baseline to 12 weeks
Title
Skeletal Muscle Mass (lbs.) using InBody 770 Scale
Description
InBody770 analyzer to define skeletal muscle mass (total weight of muscle)
Time Frame
baseline to 12 weeks
Title
Percent Body Fat using InBody 770 Scale
Description
InBody770 analyzer to define percent body fat
Time Frame
baseline to 12 weeks
Title
Weight using InBody 770 Scale
Description
InBody770 analyzer to define weight
Time Frame
baseline to 12 weeks
Title
Body Mass Index using InBody 770 Scale
Description
InBody770 analyzer to define Body Mass Index (BMI) is weight in kilograms divided by height in meters squared. A BMI of 25 or below is considered healthy.
Time Frame
baseline to 12 weeks
Title
Mindful Eating
Description
Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.
Time Frame
baseline to 12 weeks
Title
Daily Steps
Description
Number of steps participant takes in a day recorded by Actigraph Activity tracker.
Time Frame
baseline to 12 weeks
Title
Daily Sedentary Time
Description
Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status
Time Frame
baseline to 12 weeks
Title
Daily Physical Activity
Description
Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs
Time Frame
baseline to 12 weeks
Title
Exercise Capacity
Description
Six-Minute Walking Test
Time Frame
baseline to 12 weeks
Title
Sleep Time Measures
Description
Actigraph to measure total sleep time
Time Frame
baseline to 12 weeks
Title
Sleep Efficiency
Description
Time sleeping/ Time reclined
Time Frame
baseline to 12 weeks
Title
Disease specific quality of life
Description
Chronic Respiratory Questionnaire measures Fatigue , Emotions and Mastery and is a 20 item questionnaire with a range of 1-7. A higher score is best.
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs