INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

March 10, 2022 updated by: Seattle Institute for Biomedical and Clinical Research
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
684

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Birmingham VA Medical Center
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham - UAB Lung Health Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Francisco, California, United States, 94143
        • Universtiy of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Waterbury Pulmonary Associates
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Northwestern Medical Group - Pulmonology
      • Chicago, Illinois, United States, 60612
        • University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maine
      • South Portland, Maine, United States, 04106
        • Chest Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University - Pulmonary & Critical Care Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02132
        • Boston VA Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan - Division of Pulmonary & Critical Care Medicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System - Pulmonology
      • Saint Paul, Minnesota, United States, 55101
        • Minnesota Health partners
    • Missouri
      • Saint Louis, Missouri, United States, 63106
        • St. Louis VA
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Buffalo, New York, United States, 14203
        • University of Buffalo
      • Buffalo, New York, United States, 14215
        • Buffalo VA Medical Center
      • Mineola, New York, United States, 11501
        • NYU Winthrop
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Greenville, North Carolina, United States, 27834
        • East Carolina University - Pulmonary, Critical Care & Sleep Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44016
        • Case Western
      • Columbus, Ohio, United States, 43221
        • Ohio State University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital - Temple Lung Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center - Kaufmann Building
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75246
        • BSW Research
      • Houston, Texas, United States, 77505
        • Baylor College of Medicine
      • Katy, Texas, United States, 77498
        • Grand Medical Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • White River Junction VA
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lifestyle intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
No Intervention: Usual Care
Participants continue with usual diet and exercise activities as they desire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Six Minute Walk Test
Time Frame: 12 months
distance walked in six minutes
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Borg Scale
Time Frame: 12 months
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
12 months
Weight
Time Frame: 12 months
body weight
12 months
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
Time Frame: 12 months
scores range from 0-100 with higher scores reflecting better health
12 months
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
Time Frame: 12-months
scores range from 0-100 with higher scores reflecting better health
12-months
Non-laboratory Framingham Risk Score
Time Frame: 12 months
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).
12 months
Waist Circumference
Time Frame: 12 months
cardiovascular disease risk
12 months
Systolic Blood Pressure
Time Frame: 12 months
indicator of cardiovascular disease risk; higher values indicate higher risk
12 months
Body Mass Index (BMI)
Time Frame: 12 months
cardiovascular disease risk
12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
Time Frame: 12 months
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.
12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
Time Frame: 12 months
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.
12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
Time Frame: 12 months
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.
12 months
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Institute for Biomedical and Clinical Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Chicago
VA Puget Sound Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1U01HL128868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified dataset will be shared with NHLBI's data repository, Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).

IPD Sharing Time Frame

Summer 2022 and onward according to BioLINCC policy.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings