INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

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: Completed
• Conditions: Obesity; Overweight; Pulmonary Disease, Chronic Obstructive; Weight Loss; Life Style
• Intervention / Treatment: Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 684
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test	distance walked in six minutes	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: University of Illinois at Chicago; VA Puget Sound Health Care System
• Investigators: 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

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; exercise; obesity; overweight; diet; lifestyle; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Body Weight; Lung Diseases, Obstructive; Body Weight Changes; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Weight Loss; Overweight
• Other Study ID 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