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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Intervention for weight loss | Experimental | 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 Comparator | The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching and Weight Loss for patients with dyspnea | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathlessness | Chronic Respiratory Questionnaire Dyspnea | baseline to 12 weeks |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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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.
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|
| Active Control | Behavioral | Participants will receive usual care for 12 weeks followed by the active intervention. |
|
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 |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |