Pulmonary Disease, Chronic ObstructiveINSIGHT COPDNCT02634268
INtervention Study In overweiGHT Patients With COPD
A study testing Lifestyle Intervention in people with Pulmonary Disease, Chronic Obstructive and Obesity, run by Seattle Institute for Biomedical and Clinical Research at 39 sites in United States.
Trial summary
Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Obesity, Weight Loss
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 39 sitesUnited States
- Study dates
- 12 May 2017to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years or older at time of eligibility screening;
- Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
- Smoked more than 10 pack-years of cigarettes;
- Shortness of breath;
- COPD;
- Able to participate fully in all study protocol/procedures including written informed consent process.
Who cannot join
- Inability to speak, read, or understand English;
- Active weight loss interventions;
- Expected weight loss because of alternate explanations, such as from illness;
- Unable to ambulate to weight scale for weight measurement;
- Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <18 months;
- Pregnant, lactating, or planning to become pregnant during the study period;
- Participation in other intervention studies.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Albany Medical College
Albany, New York, 12208
University of Michigan - Division of Pulmonary & Critical Care Medicine
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University - Pulmonary & Critical Care Medicine
Baltimore, Maryland, 21224
Birmingham VA Medical Center
Birmingham, Alabama, 35233
University of Alabama at Birmingham - UAB Lung Health Center
Birmingham, Alabama, 35294
Boston VA Medical Center
Boston, Massachusetts, 02132
University of Buffalo
Buffalo, New York, 14203
Buffalo VA Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University - Northwestern Medical Group - Pulmonology
Chicago, Illinois, 60611
University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
Chicago, Illinois, 60612
Case Western
Cleveland, Ohio, 44016
Ohio State University
Columbus, Ohio, 43221
BSW Research
Dallas, Texas, 75246
Geisinger Medical Center
Danville, Pennsylvania, 17822
National Jewish Health
Denver, Colorado, 80206
Duke University
Durham, North Carolina, 27705
East Carolina University - Pulmonary, Critical Care & Sleep Medicine
Greenville, North Carolina, 27834
Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77505
University of Iowa
Iowa City, Iowa, 52242
Grand Medical Clinic
Katy, Texas, 77498
University of California, Los Angeles
Los Angeles, California, 90095
NYU Winthrop
Mineola, New York, 11501
Minneapolis VA Health Care System - Pulmonology
Minneapolis, Minnesota, 55417
Temple University Hospital - Temple Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center - Kaufmann Building
Pittsburgh, Pennsylvania, 15213
Minnesota Health Partners
Saint Paul, Minnesota, 55101
University of Utah
Salt Lake City, Utah, 84108
Universtiy of California, San Francisco
San Francisco, California, 94143
Sarasota Memorial Hospital
Sarasota, Florida, 34239
VA Puget Sound Health Care System
Seattle, Washington, 98108
Chest Medicine
South Portland, Maine, 04106
Baystate Health
Springfield, Massachusetts, 01199
St. Louis VA
St Louis, Missouri, 63106
University of Arizona
Tucson, Arizona, 85724
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708
White River Junction VA
White River Junction, Vermont, 05009
About this study
Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.
- Being tested
- Lifestyle Intervention
- Keywords
- randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity, Weight Loss, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Behavioral lifestyle intervention focused on healthy eating and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Active comparator | Behavioral lifestyle intervention focused on healthy eating and physical activity Receives: Behavioral: Lifestyle Intervention |
| Usual Care | No intervention | Participants continue with usual diet and exercise activities as they desire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test
distance walked in six minutes
Measured: 12 months
Secondary outcomes (12)
Modified Borg Scale
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Measured: 12 months
Weight
body weight
Measured: 12 months
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
scores range from 0-100 with higher scores reflecting better health
Measured: 12 months
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
scores range from 0-100 with higher scores reflecting better health
Measured: 12-months
Non-laboratory Framingham Risk Score
This measure uses non-laboratory-based measures (sex, age, body mass index, systolic blood pressure, use of antihypertensive treatment, smoking status, and diabetes status) to yield a score (cardiovascular disease points) representing 10-year risk of having a cardiovascular problem. Low scores (minimum of -2 for women, -3 for men) indicate low risk. Scores of 21 or higher indicate high risk (30% risk or higher).
Measured: 12 months
Waist Circumference
cardiovascular disease risk
Measured: 12 months
Systolic Blood Pressure
indicator of cardiovascular disease risk; higher values indicate higher risk
Measured: 12 months
Body Mass Index (BMI)
cardiovascular disease risk
Measured: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Measured: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Measured: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Measured: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start12 May 2017
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- David H Au, MD, MS, Principal investigator, VA Puget Sound Health Care SystemJun Ma, MD, PhD, Principal investigator, University of Illinois at Chicago - Institute for Health Research and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634268
- Sponsor's protocol ID
- 1U01HL128868
- Acronym
- INSIGHT COPD
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2015
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be shared with NHLBI's data repository, Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
Publications
Leonhard AG, Coggeshall S, Gleason E, Collins M, Barjaktarevic I, Bascom R, Bon J, Comellas AP, Diaz PT, Hanania NA, Han MK, Hansel NN, Hee Wai T, Krishnan JA, Lazarus SC, Ma J, Maddipati V, Mador MJ, Make BJ, McEvoy CE, Meldrum C, Millard MW, Moy ML, Pirozzi CS, Plumley R, Que LG, Reed RM, Sciurba FC, Sethi S, Simonelli PF, Sumino K, Tiwari A, Voelker K, Wendt CH, Wisniewski SR, Au DH, Donovan LM, Feemster LC. Effect of a self-directed lifestyle-based weight management program among patients with comorbid COPD and sleep apnea: a secondary analysis of the INSIGHT COPD trial. Ann Am Thorac Soc. 2026 Mar 1;23(3):419-428. doi: 10.1513/AnnalsATS.202504-410OC.
PubMed 41135051Au DH, Gleason E, Hunter-Merrill R, Baron AE, Collins M, Ronneberg C, Lv N, Rise P, Wai TH, Plumley R, Wisniewski SR, Sciurba FC, Kim DY, Simonelli P, Krishnan JA, Wendt CH, Feemster LC, Criner GJ, Maddipati V, Mohan A, Ma J. Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial. Ann Am Thorac Soc. 2023 Dec;20(12):1743-1751. doi: 10.1513/AnnalsATS.202305-458OC.
PubMed 37769182
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtervention Study In overweiGHT Patients With COPD
- ClinicalTrials.gov ID
- NCT02634268
- Acronym / sponsor ID
- INSIGHT COPD / 1U01HL128868
- Keywords
- randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, University of Illinois Chicago
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Active comparator | Behavioral: Lifestyle InterventionBehavioral lifestyle intervention focused on healthy eating and physical activity |
| Usual Care | No intervention | –Participants continue with usual diet and exercise activities as they desire |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 years or older at time of eligibility screening;
- Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
- Smoked more than 10 pack-years of cigarettes;
- Shortness of breath;
- COPD;
Key exclusion criteria (7 listed)
- Inability to speak, read, or understand English;
- Active weight loss interventions;
- Expected weight loss because of alternate explanations, such as from illness;
- Unable to ambulate to weight scale for weight measurement;
- Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <18 months;
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 |
|---|---|---|
| Lifestyle InterventionBehavioral lifestyle intervention focused on healthy eating and physical activity | Behavioural | Lifestyle intervention |
Primary outcome
Six Minute Walk Test
Time frame: 12 months
distance walked in six minutes
12 secondary outcomes
Modified Borg Scale
Time frame: 12 months
Weight
Time frame: 12 months
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
Time frame: 12 months
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
Time frame: 12-months
Non-laboratory Framingham Risk Score
Time frame: 12 months
Waist Circumference
Time frame: 12 months
Systolic Blood Pressure
Time frame: 12 months
Body Mass Index (BMI)
Time frame: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
Time frame: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
Time frame: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
Time frame: 12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41135051Leonhard AG, Coggeshall S, Gleason E, Collins M, Barjaktarevic I, Bascom R, Bon J, Comellas AP, Diaz PT, Hanania NA, Han MK, Hansel NN, Hee Wai T, Krishnan JA, Lazarus SC, Ma J, Maddipati V, Mador MJ, Make BJ, McEvoy CE, Meldrum C, Millard MW, Moy ML, Pirozzi CS, Plumley R, Que LG, Reed RM, Sciurba FC, Sethi S, Simonelli PF, Sumino K, Tiwari A, Voelker K, Wendt CH, Wisniewski SR, Au DH, Donovan LM, Feemster LC. Effect of a self-directed lifestyle-based weight management program among patients with comorbid COPD and sleep apnea: a secondary analysis of the INSIGHT COPD trial. Ann Am Thorac Soc. 2026 Mar 1;23(3):419-428. doi: 10.1513/AnnalsATS.202504-410OC.
- Derived from this study: PubMed 37769182Au DH, Gleason E, Hunter-Merrill R, Baron AE, Collins M, Ronneberg C, Lv N, Rise P, Wai TH, Plumley R, Wisniewski SR, Sciurba FC, Kim DY, Simonelli P, Krishnan JA, Wendt CH, Feemster LC, Criner GJ, Maddipati V, Mohan A, Ma J. Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial. Ann Am Thorac Soc. 2023 Dec;20(12):1743-1751. doi: 10.1513/AnnalsATS.202305-458OC.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be shared with NHLBI's data repository, Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
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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.
David H Au, MD, MS principal investigator
VA Puget Sound Health Care System
Jun Ma, MD, PhD principal investigator
University of Illinois at Chicago - Institute for Health Research and Policy
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Pulmonary Disease, Chronic Obstructive and Obesity, run by Seattle Institute for Biomedical and Clinical Research at 39 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 6 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Six Minute Walk Test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634268, which also lists 2 linked publications.
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 7 Apr 2022.