Background: 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 reap similar clinical benefits from modest weight loss is an intuitive - but untested - concept. Therefore, this project is a multicenter, patient-level randomized, pragmatic clinical trial to produce data on the effectiveness of an evidence-based self-directed lifestyle intervention for 12 months targeting modest weight loss and increased physical activity among overweight and obese patients with COPD.
Methods: Approximately 1000 overweight and obese COPD patients, aged 40 years and older, will be randomized to usual care (UC) or UC plus the self-directed lifestyle intervention for 12 months. The 12-month intervention that will have 2 distinct stages: core curriculum (months 1-3) and post core (months 4-12). The core curriculum will be delivered using the GLB DVD or on-line viewing option, with supplementary remote lifestyle coaching at the participant’s discretion. The coach will contact intervention participants within two weeks of randomization for phone orientation, to review the coach role in the intervention, and describe how participants may request coaching if desired. Also, the coach will send biweekly standardized messages via MyFitnessPal as reminders and/or to reinforce the lifestyle change recommendations in the videos.
Results: As an ongoing clinical trial, continuous data is being collected from study sites all across North America using the REDCap data capturing system.
Conclusion: Even though data is continuously being collected and analyzed, we are confident that this trial will provide the evidence clinicians need to appropriately and effectively treat obese patients with COPD.