MAXIMIZING RECRUITMENT EFFORTS IN A DRUG LIPID-LOWERING TRIAL WITH DIETARY INTERVENTION TO LOWER LDL CHOLESTEROL

A select group of screened applicants initially disqualified from a fo ur-center, primary prevention drug lipid-lowering trial because of bor derline elevated serum low-density lipoprotein cholesterol (LDL-C) lev els, as defined in National Cholesterol Education Program-Adult Treatm ent Panel I (NCEP-ATP I) guidelines, participated in a dietary interve ntion protocol that was incorporated into the screening phase of the t rial. Seventy-seven screened applicants for the Asymptomatic Carotid A rtery Progression Study entered the dietary program, which was oversee n by an experienced registered dietitian at the central operations sit es who collaborated with local staff at clinical sites during program implementation. NCEP-ATP I fat-modified step I diet specifications ser ved as the basis for the intervention. The program, consisting of five sessions conducted over an 8-week period, primarily used written and audiovisual educational materials in combination with behavioral appro aches. Of the original 77 participants, 36 responded to the interventi on by achieving their LDL-C goal. Twenty-nine were nonresponders and 1 2 were dropouts. Responders achieved an average 11.7% drop in total ch olesterol at the end of the 8-week program. Mean LDL-C decline paralle led total cholesterol change. High-density lipoprotein cholesterol als o decreased significantly. These results were sustained for 24 of the responders attending the final screening visit approximately a month l ater, when another fasting blood lipid measurement was made. Participa nts who dropped out were more likely to be smokers. Pre- and postinter vention nutrition data assessed by semiquantitative food frequency que stionnaire for 20 screenees randomized into the study indicated signif icant reductions in total fat, saturated fat, polyunsaturated fat, and dietary cholesterol, all known to influence blood lipid levels. Simil ar programs may prove useful to other drug lipid-lowering trials to ma ximize recruitment efforts.