THE POLYP PREVENTION TRIAL-II - DIETARY INTERVENTION PROGRAM AND PARTICIPANT BASE-LINE DIETARY CHARACTERISTICS

The Polyp Prevention Trial (PPT) is a multicenter randomized controlle d trial to evaluate whether a low-fat, high-dietary fiber, high-fruit and -vegetable eating pattern will reduce the recurrence of adenomatou s polyps of the large bowel. Men and women who had one or more adenoma s removed recently were randomized into either the intervention (it = 1037) or control (it = 1042) arms, Food frequency questionnaire data i ndicate that PPT participants at the beginning of the trial consumed 3 6.8% of total energy from fat, 9.7 g of dietary fiber/1000 kcal, and 3 .8 daily servings of fruits and vegetables, Baseline dietary character istics, including intake of fat, fiber, and fruits and vegetables, as well as other macro- and micronutrients, were similar in the two study groups, The intervention participants receive extensive dietary and b ehavioral counseling to achieve the PPT dietary goals of 20% of total energy from fat, 18 g/1000 kcal of dietary fiber, and 5-8 daily servin gs (depending on total caloric intake) of fruits and vegetables, Contr ol participants do not receive such counseling and are expected to con tinue their usual intake, Dietary intake in both groups is monitored a nnually using a 4-day food record (also completed at 6 months by inter vention participants only) and a food frequency questionnaire, with a 10% random sample of participants completing an annual unscheduled 24- h telephone recall, Blood specimens are drawn and analyzed annually fo r lipids and carotenoids, This article provides details on the rationa le and design of the PPT dietary intervention program and describes th e participant baseline dietary intake data characteristics.