COPDNCT03836547
Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
A study testing Coaching and Weight Loss for patients with dyspnea in people with COPD and Emphysema, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Emphysema, Lung Diseases
- What is being tested?
- Coaching and Weight Loss for patients with dyspnea
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Dec 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- BMI >=35
- Dyspnea MRC class II or greater
- Diagnosis of lung disease
- Signed informed consent
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
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.
Read the 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.
- Conditions
- COPD, Emphysema, Lung Diseases
- Being tested
- Coaching and Weight Loss for patients with dyspnea, Active Control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and Weight Loss for patients with dyspneaBehavioural
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 ControlBehavioural
Participants will receive usual care for 12 weeks followed by the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness
Chronic Respiratory Questionnaire Dyspnea
Measured: baseline to 12 weeks
Secondary outcomes (13)
Lean Body Mass (lbs.)using InBody 770 Scale
InBody770 analyzer to define Lean Body Mass (total body weight minus weight of fat). This measure includes organs, skin, bones, water and muscle.
Measured: baseline to 12 weeks
Skeletal Muscle Mass (lbs.) using InBody 770 Scale
InBody770 analyzer to define skeletal muscle mass (total weight of muscle)
Measured: baseline to 12 weeks
Percent Body Fat using InBody 770 Scale
InBody770 analyzer to define percent body fat
Measured: baseline to 12 weeks
Weight using InBody 770 Scale
InBody770 analyzer to define weight
Measured: baseline to 12 weeks
Body Mass Index using InBody 770 Scale
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.
Measured: baseline to 12 weeks
Mindful Eating
Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.
Measured: baseline to 12 weeks
Daily Steps
Number of steps participant takes in a day recorded by Actigraph Activity tracker.
Measured: baseline to 12 weeks
Daily Sedentary Time
Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status
Measured: baseline to 12 weeks
Daily Physical Activity
Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs
Measured: baseline to 12 weeks
Exercise Capacity
Six-Minute Walking Test
Measured: baseline to 12 weeks
Sleep Time Measures
Actigraph to measure total sleep time
Measured: baseline to 12 weeks
Sleep Efficiency
Time sleeping/ Time reclined
Measured: baseline to 12 weeks
Disease specific quality of life
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.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start19 Dec 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836547
- Sponsor's protocol ID
- 18-001832
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
- ClinicalTrials.gov ID
- NCT03836547
- Acronym / sponsor ID
- 18-001832
- Conditions
- COPD, Emphysema, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Intervention for weight loss | Experimental | Behavioral: Coaching and Weight Loss for patients with dyspnea12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching. |
| Wait-list Control | Active comparator | Behavioral: Active ControlThe participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- BMI >=35
- Dyspnea MRC class II or greater
- Diagnosis of lung disease
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching and Weight Loss for patients with dyspneaPatients 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. | Behavioural | Multicomponent Intervention for weight loss |
| Active ControlParticipants will receive usual care for 12 weeks followed by the active intervention. | Behavioural | Wait-list Control |
Primary outcome
Breathlessness
Time frame: baseline to 12 weeks
Chronic Respiratory Questionnaire Dyspnea
13 secondary outcomes
Lean Body Mass (lbs.)using InBody 770 Scale
Time frame: baseline to 12 weeks
Skeletal Muscle Mass (lbs.) using InBody 770 Scale
Time frame: baseline to 12 weeks
Percent Body Fat using InBody 770 Scale
Time frame: baseline to 12 weeks
Weight using InBody 770 Scale
Time frame: baseline to 12 weeks
Body Mass Index using InBody 770 Scale
Time frame: baseline to 12 weeks
Mindful Eating
Time frame: baseline to 12 weeks
Daily Steps
Time frame: baseline to 12 weeks
Daily Sedentary Time
Time frame: baseline to 12 weeks
Daily Physical Activity
Time frame: baseline to 12 weeks
Exercise Capacity
Time frame: baseline to 12 weeks
Sleep Time Measures
Time frame: baseline to 12 weeks
Sleep Efficiency
Time frame: baseline to 12 weeks
Disease specific quality of life
Time frame: baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto P Benzo principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Weight Loss for patients with dyspnea in people with COPD and Emphysema, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.