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

Not Applicable

Completed

• Conditions: COPD; Emphysema; Lung Diseases
• Interventions: Behavioral: Coaching and Weight Loss for patients with dyspnea; Behavioral: Active Control

• Registration Number: NCT03836547
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-12-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multicomponent Intervention for weight loss	Coaching and Weight Loss for patients with dyspnea	12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.
Wait-list Control	Active Control	The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.

Primary Outcome Measures

Name	Time	Method
Breathlessness	baseline to 12 weeks	Chronic Respiratory Questionnaire Dyspnea

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States