INtervention Study In overweiGHT Patients With COPD
- Conditions
- Weight LossLife StylePulmonary Disease, Chronic ObstructiveObesityOverweight
- Interventions
- Behavioral: Lifestyle Intervention
- Registration Number
- NCT02634268
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle intervention Lifestyle Intervention Behavioral lifestyle intervention focused on healthy eating and physical activity
- Primary Outcome Measures
Name Time Method Six Minute Walk Test 12 months distance walked in six minutes
- Secondary Outcome Measures
Name Time Method Systolic Blood Pressure 12 months indicator of cardiovascular disease risk; higher values indicate higher risk
Body Mass Index (BMI) 12 months cardiovascular disease risk
Non-laboratory Framingham Risk Score 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).
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score 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.
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score 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.
Weight 12 months body weight
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) 12-months scores range from 0-100 with higher scores reflecting better health
Waist Circumference 12 months cardiovascular disease risk
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score 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.
Modified Borg Scale 12 months Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) 12 months scores range from 0-100 with higher scores reflecting better health
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score 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.
Trial Locations
- Locations (39)
University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Albany Medical College
🇺🇸Albany, New York, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Northwestern University - Northwestern Medical Group - Pulmonology
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
NYU Winthrop
🇺🇸Mineola, New York, United States
Chest Medicine
🇺🇸South Portland, Maine, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
White River Junction VA
🇺🇸White River Junction, Vermont, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Waterbury Pulmonary Associates
🇺🇸Waterbury, Connecticut, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Johns Hopkins University - Pulmonary & Critical Care Medicine
🇺🇸Baltimore, Maryland, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Baystate Health
🇺🇸Springfield, Massachusetts, United States
BSW Research
🇺🇸Dallas, Texas, United States
Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
🇺🇸Hershey, Pennsylvania, United States
Buffalo VA Medical Center
🇺🇸Buffalo, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Temple University Hospital - Temple Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
Universtiy of California, San Francisco
🇺🇸San Francisco, California, United States
Minneapolis VA Health Care System - Pulmonology
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Birmingham VA Medical Center
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham - UAB Lung Health Center
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Michigan - Division of Pulmonary & Critical Care Medicine
🇺🇸Ann Arbor, Michigan, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Boston VA Medical Center
🇺🇸Boston, Massachusetts, United States
Minnesota Health Partners
🇺🇸Saint Paul, Minnesota, United States
St. Louis VA
🇺🇸Saint Louis, Missouri, United States
Case Western
🇺🇸Cleveland, Ohio, United States
East Carolina University - Pulmonary, Critical Care & Sleep Medicine
🇺🇸Greenville, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Pittsburgh Medical Center - Kaufmann Building
🇺🇸Pittsburgh, Pennsylvania, United States
Grand Medical Clinic
🇺🇸Katy, Texas, United States
VA Puget Sound Health Care System
🇺🇸Seattle, Washington, United States