? DESCRIPTION (provided by applicant): Approximately 70% of patients with Chronic Obstructive Pulmonary Disease (COPD) are obese or overweight. Tobacco smoking that causes COPD also is associated with other poor health habits that can lead to obesity and cardiovascular disease. Symptoms of COPD are often non-specific and include dyspnea and exercise intolerance. COPD treatment guidelines recommend stepped escalation of inhaled medications to improve these symptoms, but make little mention of the effect of co-existing obesity or weight loss interventions because of insufficient evidence. Cardiovascular disease is a leading cause of mortality among patients with COPD, and obesity is associated with important risk factors for cardiovascular disease including dyslipidemia, hypertension, and diabetes. Comprehensive lifestyle interventions that include calorie-controlled healthy eating, increased physical activity, and behavioral self-management strategies consistently result in modest, clinically significant weight loss and associated reductions in cardiovascular risk factors. That overweight and obese patients with COPD would not only reap similar clinical benefits from modest weight loss is an intuitive - but untested - concept. Therefore, we propose to conduct a highly valid, multicenter, patient-level randomized, pragmatic clinical trial to produce first-ever data on the effectiveness of a self-directed 12-month evidence-based lifestyle intervention targeting modest weight loss and increased physical activity among overweight and obese patients with COPD. We aim to serve as a Protocol Leadership Group (PLG) for the National Heart, Lung, and Blood Institute's Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (PTC) in order to test if intervention participants have better outcomes through 24 months of follow-up compared to usual care control patients in terms of weight loss, exercise tolerance using the 6-Minute Walk Test, and dyspnea using the Borg dyspnea score. Secondary outcomes include, generic health-related quality of life using the SF-12, and major cardiovascular risk factors using Framingham risk score (including lipids), central obesity by waist circumference and blood pressure. We will oversee enrollment of 1000 patients at multiple clinical sites eventually chosen and contracted by the PTC's Network Management Core (NEMO). As the PLG for our proposed HOPE trial, we will cooperate with NEMO and will provide trial oversight, data management and reporting, and safety monitoring.
|Effective start/end date||8/1/15 → 7/31/19|