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

Mayo Clinic

Status: Completed

Conditions: Lung Diseases; Emphysema; COPD

Treatments: Behavioral: Coaching and Weight Loss for patients with dyspnea; Behavioral: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03836547

18-001832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Multicomponent Intervention for weight loss

Experimental group

Description:

12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.

Treatment:

Behavioral: Coaching and Weight Loss for patients with dyspnea

Wait-list Control

Active Comparator group

Description:

The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.

Treatment:

Behavioral: Active Control