Overall Study Plan

The Watch II Study is a 4½ year study in which 1200 pts of study physicians with LDL-C levels in the highest quartile were randomized to one of two conditions, with 600 pts randomized per condition. All of the study physicians will receive identical training in pt-centered counseling for nutrition change; and will be provided with the office support program and referral access to the Group Nutrition Intervention program (GNI). Training and an office support program comprised the successful condition III intervention utilized in WATCH. In addition, pts in the Intervention condition will receive systems-based interventions interwoven with the physician intervention, to include a Systems-Based Lipid Management Program (SBLMP), and other support materials (videotapes, audiotapes, and monthly newsletters). A 3-month run-in phase, involving 200 pts (40, 60, and 100 in months 1-3, respectively), will allow testing and refinement of the program.

All pts have baseline lipid profile measurements completed prior to their first physician visit. Physicians in both treatment conditions are provided with the study-qualifying lipid profile results (see D.10.1.1.). The intervention components are illustrated in Table D.1. The evaluation assesses differences at one year in pt intake of SFA (% energy) and changes in serum LDL-C levels as the primary study endpoints, with change in total fat intake, body weight, and physician practices as secondary endpoints. We also assess changes in physician knowledge and attitudes; and assess the cost and cost-effectiveness of the delivered intervention. Patient knowledge, attitudes and behaviors related to diet modification and other psychosocial and demographic variables are also assessed.

^{Table D.1. - Components of Treatment Conditions}