INtervention Study In overweiGHT Patients With COPD

Study Overview
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Brief Summary
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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.

Official Title
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INtervention Study In overweiGHT Patients With COPD

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

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle intervention<br>Behavioral lifestyle intervention focused on healthy eating and physical activity | Behavioral: Lifestyle Intervention<br>* Behavioral lifestyle intervention focused on healthy eating and physical activity<br>|
| No Intervention: Usual Care<br>Participants continue with usual diet and exercise activities as they desire | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle