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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836547
• Other study ID #: 18-001832
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Emphysema
• Lung Diseases

Intervention

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 Control
Participants will receive usual care for 12 weeks followed by the active intervention.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathlessness	Chronic Respiratory Questionnaire Dyspnea	baseline to 12 weeks
Secondary	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
Secondary	Skeletal Muscle Mass (lbs.) using InBody 770 Scale	InBody770 analyzer to define skeletal muscle mass (total weight of muscle)	baseline to 12 weeks
Secondary	Percent Body Fat using InBody 770 Scale	InBody770 analyzer to define percent body fat	baseline to 12 weeks
Secondary	Weight using InBody 770 Scale	InBody770 analyzer to define weight	baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	Daily Steps	Number of steps participant takes in a day recorded by Actigraph Activity tracker.	baseline to 12 weeks
Secondary	Daily Sedentary Time	Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status	baseline to 12 weeks
Secondary	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
Secondary	Exercise Capacity	Six-Minute Walking Test	baseline to 12 weeks
Secondary	Sleep Time Measures	Actigraph to measure total sleep time	baseline to 12 weeks
Secondary	Sleep Efficiency	Time sleeping/ Time reclined	baseline to 12 weeks
Secondary	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

External Links

•   Mayo Clinic Clinical Trials