Optimal nutritional management of the 40 million Americans with significant hyperlipidemia requires efficient, inexpensive and widely available methods. The investigators have previously demonstrated the efficacy of a computerized nutritional intervention, (Computer-Assisted Learning System, CALS) in reducing plasma cholesterol. The proposed research compared the efficacy of 3 interventions of graded intensity: 1) a nutritional manual alone, 2) the manual plus CALS and 3) the manual plus CALS plus supplemental nutritional counseling and followup telephone contacts. Prior to randomization, all 3 groups received brief, standardized instruction from primary care physicians about the clinical importance of nutritional management of hyperlipidemia. CALS uses data obtained form food frequency questionnaire (FFQ) , completed at baseline and at 3 and 7 weeks. FFQ responses direct the computer generation of printed individualized progress reports at 4 and 8 weeks that provide nutritional goals and explicit feedback of progress toward these goals. FFQ and progress reports are sent through the mail; patients do not interact with the computer. A total of 750 men and women aged 30-69 receiving care in two San Francisco Bay are Kaiser-Permanente (K- P)Medical Center whose plasma cholesterol values on multiphasic health evaluation need NCEP criteria for medically-supervised nutritional intervention will be randomized, 250 to each of 3 groups. The primary outcome measure is plasma LDL cholesterol, measured at 12, 24 and 48 weeks. A 10 mg/dl or greater reduction in plasma LDL cholesterol is considered clinically important. Sample size is set to yield sufficient power to detect such a difference between any pair of interventions. The primary aim of the study is to determine the efficacy of CALS compared to usual care ie. physician counseling plus bibliotherapy (group 1 versus 2) and the extent to which the efficacy of CALS is further enhanced b nutritionist-mediated counseling (group 2 versus 3). CALS could help to triage patients into three groups: 1. those whose plasma LDL cholesterol decreases in response to nutritional change, 2. those whose plasma LDL cholesterol does not decrease in response to nutritional change and 3. those who have not changed their diets significantly. Depending on other coronary risk factors, patients in these three groups may required no further therapy, lipid-lowering drugs or nutritionist-mediated counseling, respectively. CALS; low cost of $ per person and its wide availability and convenience could spur its adoption by millions of hyperlipidemia Americans who are not presently receiving, and are unlikely to receive, nutritionist-mediated counseling. Moreover, CALS could help to identify patients most in need of nutritionist-mediated counseling. Future studies using CALS can address the effectiveness of CALS in different patient populations and health care delivery settings and the long-term maintenance of nutritional change.
