We propose a randomized controlled trial to evaluate how well an intervention, Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of obesity in adults with at least one cardiovascular risk factor (CVRF). We will assess how well it creates initial and sustained improvements in BMI and metabolic, anthropometric and behavioral outcomes in obese adults, age 25 to 70 who have one or more of the following CVRFs: hypertension, smoking or the metabolic syndrome. Planned CORR integrates intervention components based on behavior change theory with a delivery strategy based on the Chronic Care Model (Wagner et al, 2001;also called the ?Planned Care Model?) and is designed to incorporate intervention principles used successfully to treat obesity while at the same time supporting the management of one or more CVRFs. Planned CORR is intended to be compatible with a variety of primary care settings including those with minimal resources to devote to patient education and where most obese adults receive their usual medical care. After formative work to ensure that intervention components are useful to intended participants, we will recruit 274 women and men, age 25-70 who meet the entry criteria of obesity (Class I ⅈBMI 30-39.9) plus one or more CVRFs. We anticipate that approximately 40% will be Hispanic. Planned CORR is a stepped care intervention that begins with computer-assisted assessment and tailored action planning, physician or nurse practitioner counseling, and an intensive ?first step? of 4 months of lifestyle modification delivered via monthly in-person sessions and phone calls and weekly web or mail (based on preference) tutorials. CVRFs are managed concurrently according to recognized evidence-based protocols. Successive 4-month steps involve more, the same, or less intensive intervention depending on clinical response. The primary aim is to evaluate the effects at 12 &24 months of Planned CORR on BMI when compared to enhanced usual care. Secondary aims will evaluate: CVRF outcomes;physiological, metabolic, behavioral, and psychosocial factors related to obesity and CVRFs;quality of life &depression;patient, provider &staff satisfaction;and process measures relevant to implementation in primary care. Project Narrative The aim of this project is to explore how to improve the way primary care providers provide services to their patients who are overweight and who also have other important medical conditions or health risks such as hypertension, smoking or high cholesterol. Because these patients require a complicated treatment course that includes regular use of medications and individual or group health behavior counseling, their needs are often poorly addressed. This study will explore the use of a systems-based approach to improve these services.
| Liu, Jie; Godino, Job G; Norman, Gregory J et al. (2018) Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial. Prev Med 114:223-231 |
