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OpenTrials
Completed

NCT Number: NCT03836547

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Active Control

Behavioral

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

Primary outcomes

  1. Breathlessness

    Time frame: baseline to 12 weeks

    Chronic Respiratory Questionnaire Dyspnea

Secondary outcomes

  1. Lean Body Mass (lbs.)using InBody 770 Scale

    Time frame: 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.

  2. Skeletal Muscle Mass (lbs.) using InBody 770 Scale

    Time frame: baseline to 12 weeks

    InBody770 analyzer to define skeletal muscle mass (total weight of muscle)

  3. Percent Body Fat using InBody 770 Scale

    Time frame: baseline to 12 weeks

    InBody770 analyzer to define percent body fat

  4. Weight using InBody 770 Scale

    Time frame: baseline to 12 weeks

    InBody770 analyzer to define weight

  5. Body Mass Index using InBody 770 Scale

    Time frame: 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.

  6. Mindful Eating

    Time frame: 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.

  7. Daily Steps

    Time frame: baseline to 12 weeks

    Number of steps participant takes in a day recorded by Actigraph Activity tracker.

  8. Daily Sedentary Time

    Time frame: baseline to 12 weeks

    Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status

  9. Daily Physical Activity

    Time frame: 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

  10. Exercise Capacity

    Time frame: baseline to 12 weeks

    Six-Minute Walking Test

  11. Sleep Time Measures

    Time frame: baseline to 12 weeks

    Actigraph to measure total sleep time

  12. Sleep Efficiency

    Time frame: baseline to 12 weeks

    Time sleeping/ Time reclined

  13. Disease specific quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2019
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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