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

NCT03836547 | Completed

• 1 other identifier: 18-001832
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

COPD; Emphysema; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Breathlessness

  Chronic Respiratory Questionnaire Dyspnea

  baseline to 12 weeks

Secondary Outcomes (13)

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

  baseline to 12 weeks

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

  baseline to 12 weeks

• Percent Body Fat using InBody 770 Scale

  baseline to 12 weeks

• Weight using InBody 770 Scale

  baseline to 12 weeks

• Body Mass Index using InBody 770 Scale

  baseline to 12 weeks

Study Arms (2)

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.

Behavioral: Coaching and Weight Loss for patients with dyspnea

Wait-list Control

ACTIVE COMPARATOR

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

Behavioral: Active Control

Interventions

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.

Multicomponent Intervention for weight loss

Active Control BEHAVIORAL

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

Wait-list Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• BMI \>=35
• Dyspnea MRC class II or greater
• Diagnosis of lung disease
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Roberto P Benzo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 11, 2019
• Study Start: December 19, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)