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INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham VA Medical Center
  • University of Alabama at Birmingham - UAB Lung Health Center
  • University of Arizona
  • University of California, Los Angeles
  • Universtiy of California, San Francisco
  • National Jewish Health
  • Waterbury Pulmonary Associates
  • Sarasota Memorial Hospital
  • Northwestern University - Northwestern Medical Group - Pulmonology
  • University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
  • University of Iowa
  • Chest Medicine
  • University of Maryland
  • Johns Hopkins University - Pulmonary & Critical Care Medicine
  • Boston VA Medical Center
  • Baystate Health
  • University of Michigan - Division of Pulmonary & Critical Care Medicine
  • Minneapolis VA Health Care System - Pulmonology
  • Minnesota Health Partners
  • St. Louis VA
  • Albany Medical College
  • University of Buffalo
  • Buffalo VA Medical Center
  • NYU Winthrop
  • Duke University
  • East Carolina University - Pulmonary, Critical Care & Sleep Medicine
  • Case Western
  • Ohio State University
  • Geisinger Medical Center
  • Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
  • Temple University Hospital - Temple Lung Center
  • University of Pittsburgh Medical Center - Kaufmann Building
  • Medical University of South Carolina
  • BSW Research
  • Baylor College of Medicine
  • Grand Medical Clinic
  • University of Utah
  • White River Junction VA
  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lifestyle intervention

Usual Care

Arm Description

Behavioral lifestyle intervention focused on healthy eating and physical activity

Participants continue with usual diet and exercise activities as they desire

Outcomes

Primary Outcome Measures

Six Minute Walk Test
distance walked in six minutes

Secondary Outcome Measures

Modified Borg Scale
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Weight
body weight
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
scores range from 0-100 with higher scores reflecting better health
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
scores range from 0-100 with higher scores reflecting better health
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).
Waist Circumference
cardiovascular disease risk
Systolic Blood Pressure
indicator of cardiovascular disease risk; higher values indicate higher risk
Body Mass Index (BMI)
cardiovascular disease risk
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.
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.
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.
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.

Full Information

First Posted
December 10, 2015
Last Updated
March 10, 2022
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
VA Puget Sound Health Care System, University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02634268
Brief Title
INtervention Study In overweiGHT Patients With COPD
Acronym
INSIGHT COPD
Official Title
INtervention Study In overweiGHT Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
VA Puget Sound Health Care System, University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Obesity, Weight Loss, Life Style, Overweight
Keywords
randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
684 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Active Comparator
Arm Description
Behavioral lifestyle intervention focused on healthy eating and physical activity
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants continue with usual diet and exercise activities as they desire
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
Behavioral lifestyle intervention focused on healthy eating and physical activity
Primary Outcome Measure Information:
Title
Six Minute Walk Test
Description
distance walked in six minutes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Modified Borg Scale
Description
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Time Frame
12 months
Title
Weight
Description
body weight
Time Frame
12 months
Title
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
Description
scores range from 0-100 with higher scores reflecting better health
Time Frame
12 months
Title
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
Description
scores range from 0-100 with higher scores reflecting better health
Time Frame
12-months
Title
Non-laboratory Framingham Risk Score
Description
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).
Time Frame
12 months
Title
Waist Circumference
Description
cardiovascular disease risk
Time Frame
12 months
Title
Systolic Blood Pressure
Description
indicator of cardiovascular disease risk; higher values indicate higher risk
Time Frame
12 months
Title
Body Mass Index (BMI)
Description
cardiovascular disease risk
Time Frame
12 months
Title
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
Description
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.
Time Frame
12 months
Title
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
Description
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.
Time Frame
12 months
Title
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
Description
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.
Time Frame
12 months
Title
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Au, MD, MS
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Organizational Affiliation
University of Illinois at Chicago - Institute for Health Research and Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham - UAB Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Universtiy of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Waterbury Pulmonary Associates
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Northwestern University - Northwestern Medical Group - Pulmonology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Chest Medicine
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University - Pulmonary & Critical Care Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston VA Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan - Division of Pulmonary & Critical Care Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minneapolis VA Health Care System - Pulmonology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Minnesota Health Partners
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
St. Louis VA
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Buffalo VA Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
NYU Winthrop
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
East Carolina University - Pulmonary, Critical Care & Sleep Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44016
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University Hospital - Temple Lung Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center - Kaufmann Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
BSW Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Grand Medical Clinic
City
Katy
State/Province
Texas
ZIP/Postal Code
77498
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
White River Junction VA
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://biolincc.nhlbi.nih.gov/home/

Learn more about this trial

INtervention Study In overweiGHT Patients With COPD

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