INtervention Study In overweiGHT Patients With COPD

Not Applicable

Completed

Conditions: Weight Loss
Life Style
Pulmonary Disease, Chronic Obstructive
Obesity
Overweight

Registration Number: NCT02634268

Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

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

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Six Minute Walk Test	12 months	distance walked in six minutes

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
Weight	12 months	body weight

Trial Locations

Locations (39): Birmingham VA Medical Center
🇺🇸
Birmingham, Alabama, United States
University of Alabama at Birmingham - UAB Lung Health Center
🇺🇸
Birmingham, Alabama, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
University of California, Los Angeles
🇺🇸
Los Angeles, California, United States
Universtiy of California, San Francisco
🇺🇸
San Francisco, California, United States
National Jewish Health
🇺🇸
Denver, Colorado, United States
Waterbury Pulmonary Associates
🇺🇸
Waterbury, Connecticut, United States
Sarasota Memorial Hospital
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Sarasota, Florida, United States
Northwestern University - Northwestern Medical Group - Pulmonology
🇺🇸
Chicago, Illinois, United States
University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
🇺🇸
Chicago, Illinois, United States
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Birmingham VA Medical Center
🇺🇸Birmingham, Alabama, United States