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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COPD, Emphysema, Lung Diseases

Intervention / Treatment
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* Behavioral: Coaching and Weight Loss for patients with dyspnea
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent Intervention for weight loss<br>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<br>* 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.<br>|
| Active Comparator: Wait-list Control<br>The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention. | Behavioral: Active Control<br>* Participants will receive usual care for 12 weeks followed by the active intervention.<br>|

What is the study measuring?
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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 |