? ? An extensive body of evidence from efficacy trials, including several behavioral intervention trials conducted by the Hopkins investigators, has documented that weight loss is achievable. However, primary care providers typically had no direct involvement in the interventions. We propose a 3 group, randomized trial to determine the effectiveness of two integrated clinical-behavioral interventions (ICBIs). Participants will be 300 overweight or obese individuals with medication-treated hypertension, who are patients at two primary care clinics. The comparison group, as well as both ICBIs, will receive an evidence-based program to improve hypertension control. One ICBI, termed ICBI-IP, is a multi-channel intervention with in-person visits delivered by health counselors at the Hopkins center. This intervention is similar to traditional in-person interventions tested in efficacy trials; however, some in-person contacts are replaced with other types of contacts (telephone, web, email) in order to reduce costs and improve efficiency. The other ICBI, termed ICBI-Remote, is a multi-channel intervention (telephone, web, email) without in-person visits implemented by trained counselors of Healthways, Inc, a leading Disease Management company. This research effort builds upon previous research conducted by the investigators. Both ICBIs will be theory-guided interventions, adapted from PREMIER, an efficacy trial in which interventions lowered weight and controlled hypertension. Each ICBI will implement well-established behavioral techniques to accomplish weight loss, and each will use a web-based tool to facilitate communication among counselors, participants and clinicians; self- monitoring by participants; and feedback by counselors and clinicians. Both ICBIs will actively engage primary care providers. The primary outcome variable will be BMI and the secondary outcome hypertension control. Both ICBI should reduce weight. Critical questions are the extent of weight loss from each program. ICBI-IP might reduce weight to a greater extent than ICBI-Remote. Still, ICBI-Remote should be less expensive and more flexible. ICBI-IP could be implemented in a variety of settings (e.g. wellness programs, large clinics), while ICBI-Remote has the advantage of being readily 'scalable', that is, if successful, it could be rapidly implemented. In short, this translation study should provide the scientific foundation for efforts to control weight and improve hypertension control in overweight or obese medical patients. ? ? ?
Showing the most recent 10 out of 14 publications
