Diet and reinfarction trial (DART): design, recruitment, and compliance

A randomized controlled trial has been set up to examine the effect of diet on the secondary prevention of myocardial infarction, involving 2033 men. The trial has a factorial design, subjects being randomized independently to receive advice or no advice regarding three dietary factors: 1. a reduction in total fat and an increase in polyunsaturated fat intake; 2. an increase in fatty fish intake; 3. an increase in cereal fibre intake. Nearly half the men under 70 years of age who survived myocardial infarction during the recruitment period entered the trial, the commonest reason for exclusion being that the subject was already eating (or intended to eat) a diet which included one or more of the regimens being investigated. Detailed dietary questionnaires were completed by each subject after 6 months in the trial. The results suggest that compliance with the advice is reasonably good. The differences between the diets of the groups given and not given advice on fish and fibre were substantial; the difference attributable to advice on fat has been somewhat less than anticipated, partly because of failure to comply with advice and partly because of spontaneous changes in the diets of control subjects.