INtervention Study In overweiGHT Patients With COPD
INSIGHT COPD
1 other identifier
interventional
684
1 country
39
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedApril 7, 2022
March 1, 2022
3.5 years
December 10, 2015
December 7, 2021
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six Minute Walk Test
distance walked in six minutes
12 months
Secondary Outcomes (12)
Modified Borg Scale
12 months
Weight
12 months
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
12 months
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
12-months
Non-laboratory Framingham Risk Score
12 months
- +7 more secondary outcomes
Study Arms (2)
Lifestyle intervention
ACTIVE COMPARATORBehavioral lifestyle intervention focused on healthy eating and physical activity
Usual Care
NO INTERVENTIONParticipants continue with usual diet and exercise activities as they desire
Interventions
Behavioral lifestyle intervention focused on healthy eating and physical activity
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Birmingham VA Medical Center
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham - UAB Lung Health Center
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Universtiy of California, San Francisco
San Francisco, California, 94143, United States
National Jewish Health
Denver, Colorado, 80206, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Northwestern University - Northwestern Medical Group - Pulmonology
Chicago, Illinois, 60611, United States
University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Chest Medicine
South Portland, Maine, 04106, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University - Pulmonary & Critical Care Medicine
Baltimore, Maryland, 21224, United States
Boston VA Medical Center
Boston, Massachusetts, 02132, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
University of Michigan - Division of Pulmonary & Critical Care Medicine
Ann Arbor, Michigan, 48109, United States
Minneapolis VA Health Care System - Pulmonology
Minneapolis, Minnesota, 55417, United States
Minnesota Health Partners
Saint Paul, Minnesota, 55101, United States
St. Louis VA
St Louis, Missouri, 63106, United States
Albany Medical College
Albany, New York, 12208, United States
University of Buffalo
Buffalo, New York, 14203, United States
Buffalo VA Medical Center
Buffalo, New York, 14215, United States
NYU Winthrop
Mineola, New York, 11501, United States
Duke University
Durham, North Carolina, 27705, United States
East Carolina University - Pulmonary, Critical Care & Sleep Medicine
Greenville, North Carolina, 27834, United States
Case Western
Cleveland, Ohio, 44016, United States
Ohio State University
Columbus, Ohio, 43221, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
Hershey, Pennsylvania, 17033, United States
Temple University Hospital - Temple Lung Center
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center - Kaufmann Building
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
BSW Research
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77505, United States
Grand Medical Clinic
Katy, Texas, 77498, United States
University of Utah
Salt Lake City, Utah, 84108, United States
White River Junction VA
White River Junction, Vermont, 05009, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Related Publications (1)
Au 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.
PMID: 37769182DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margaret Collins
- Organization
- VA Puget Sound Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
David H Au, MD, MS
VA Puget Sound Health Care System
- PRINCIPAL INVESTIGATOR
Jun Ma, MD, PhD
University of Illinois at Chicago - Institute for Health Research and Policy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 18, 2015
Study Start
May 12, 2017
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
April 7, 2022
Results First Posted
February 9, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Summer 2022 and onward according to BioLINCC policy.
- Access Criteria
- Researchers may submit a data request vis BioLINCC, including description of the research plan/protocol, and documentation of review from an Institutional Review Board (IRB) or Ethics Committee (EC). Once those requirements are met and the request is approved by the NHLBI, BioLINCC staff will provide a Research Materials Distribution Agreement (RMDA) to be signed by a designated Principal Investigator and an authorized business official from the receiving institution, prior to data release.
A de-identified dataset will be shared with NHLBI's data repository, Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).