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

NCT ID: NCT03836547

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COPD Emphysema Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multicomponent Intervention for weight loss

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

Group Type EXPERIMENTAL

Coaching and Weight Loss for patients with dyspnea

Intervention Type 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.

Wait-list Control

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

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

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

Interventions

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Coaching 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.

Intervention Type BEHAVIORAL

Active Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Roberto P. Benzo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto P Benzo

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-001832

Identifier Type: -

Identifier Source: org_study_id

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