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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Emphysema; COPD
• Intervention / Treatment: Behavioral: Coaching and Weight Loss for patients with dyspnea; Behavioral: Active Control

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent Intervention for weight loss; 12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.	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.
Active Comparator: Wait-list Control; The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.	Behavioral: Active Control; Participants will receive usual care for 12 weeks followed by the active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathlessness	Chronic Respiratory Questionnaire Dyspnea	baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline to 12 weeks
Skeletal Muscle Mass (lbs.) using InBody 770 Scale	InBody770 analyzer to define skeletal muscle mass (total weight of muscle)	baseline to 12 weeks
Percent Body Fat using InBody 770 Scale	InBody770 analyzer to define percent body fat	baseline to 12 weeks
Weight using InBody 770 Scale	InBody770 analyzer to define weight	baseline to 12 weeks
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.	baseline to 12 weeks
Mindful Eating	Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.	baseline to 12 weeks
Daily Steps	Number of steps participant takes in a day recorded by Actigraph Activity tracker.	baseline to 12 weeks
Daily Sedentary Time	Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status	baseline to 12 weeks
Daily Physical Activity	Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs	baseline to 12 weeks
Exercise Capacity	Six-Minute Walking Test	baseline to 12 weeks
Sleep Time Measures	Actigraph to measure total sleep time	baseline to 12 weeks
Sleep Efficiency	Time sleeping/ Time reclined	baseline to 12 weeks
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.	baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Emphysema; Dyspnea
• Other Study ID Numbers: 18-001832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No