COPD, Emphysema, Lung Diseases
Conditions
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.
Interventions
BEHAVIORALCoaching 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.
BEHAVIORALActive Control
Participants will receive usual care for 12 weeks followed by the active intervention.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness | baseline to 12 weeks | Chronic Respiratory Questionnaire Dyspnea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Daily Steps | baseline to 12 weeks | Number of steps participant takes in a day recorded by Actigraph Activity tracker. |
| Weight using InBody 770 Scale | baseline to 12 weeks | InBody770 analyzer to define weight |
| 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 |
| Exercise Capacity | baseline to 12 weeks | Six-Minute Walking Test |
| Sleep Time Measures | baseline to 12 weeks | Actigraph to measure total sleep time |
| Sleep Efficiency | baseline to 12 weeks | Time sleeping/ Time reclined |
| 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. |
| Daily Sedentary Time | baseline to 12 weeks | Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status |
Countries
United States
Outcome results
None listed