Implementation of a 4-y, high-fiber, high-fruit-and-vegetable, low-fat dietary intervention: results of dietary changes in the Polyp Prevention Trial.

BACKGROUND: The Polyp Prevention Trial (PPT) was a multicenter randomized clinical trial designed to determine the effects of a high-fiber (4.30 g/MJ), high-fruit-and-vegetable (0.84 servings/MJ), low-fat (20% of energy from fat) diet on the recurrence of adenomatous polyps in the large bowel. OBJECTIVE: Our goal was to determine whether the PPT intervention plan could effect change in 3 dietary goals and to examine the intervention's effect on the intake of other food groups and nutrients. DESIGN: Participants with large-bowel adenomatous polyps diagnosed in the past 6 mo were randomly assigned to either the intervention (n = 1037) or the control (n = 1042) group and remained in the trial for 4 y. Three dietary assessment instruments were used to measure dietary change: food-frequency questionnaires (in 100% of the sample), 4-d food records (in a 20% random cohort), and 24-h dietary recalls (in a 10% random sample). RESULTS: Intervention participants made and sustained significant changes in all PPT goals as measured by the dietary assessment instruments; the control participants' intakes remained essentially the same throughout the trial. The absolute differences between the intervention and control groups over the 4-y period were 9.7% of energy from fat (95% CI: 9.0%, 10.3%), 1.65 g dietary fiber/MJ (95% CI: 1.53, 1.74), and 0.27 servings of fruit and vegetables/MJ (95% CI: 0.25, 0.29). Intervention participants also reported significant changes in the intake of other nutrients and food groups. The intervention group also had significantly higher serum carotenoid concentrations and lower body weights than did the control group. CONCLUSION: Motivated, free-living individuals, given appropriate support, can make and sustain major dietary changes over a 4-y period.

Self-rated quality of life measures: effect of change to a low-fat, high-fiber, fruit and vegetable enriched diet.

The Polyp Prevention Trial (PPT) was a multicenter, randomized clinical trial to determine the effect of a low-fat (20% of energy from fat), high-fiber (18 g/1,000 kcal/day), high-fruit/vegetable (3.5 servings/1,000 kcal/day) eatingplan on the recurrence of large bowel adenomatous polyps. The PPT provided an opportunity to examine the impact of dietary changes on quality of life. At baseline and annuallyfor 4 years, participants in the Quality of Life Substudy of PPT completed a Quality of Life Factors (QF) Questionnaire, a modified Block-National Cancer Institute Food Frequency Questionnaire, and a Health and Lifestyle Questionnaire. The 51-item QF Questionnaire assessed changes in nine domains: taste, convenience, cost, self-care, social, health assessment, health belief health action, and life satisfaction. The analysis compared annual changes in domain scores for intervention (n = 194) and control (n = 200) participants. At Year 1, 363 (92%) completed a questionnaire, and 325 (82%) participants completed a Year 4 questionnaire. There were no statistically significant differences between treatment groups in the change from baseline to Year 1 for the convenience, cost, taste, health assessment, and life satisfaction domains. At Year 1, intervention participants rated the self-care (p < .001), health belief (p = .021), and health action (p < .001) domains significantly higher and the social domain significantly lower (p <.001) than control participants. These changes were consistent through Years 2, 3, and 4. This study

The polyp prevention trial II: dietary intervention program and participant baseline dietary characteristics.

The Polyp Prevention Trial (PPT) is a multicenter randomized controlled trial to evaluate whether a low-fat, high-dietary fiber, high-fruit and -vegetable eating pattern will reduce the recurrence of adenomatous polyps of the large bowel. Men and women who had one or more adenomas removed recently were randomized into either the intervention (n = 1037) or control (n = 1042) arms. Food frequency questionnaire data indicate that PPT participants at the beginning of the trial consumed 36.8% of total energy from fat, 9.7 g of dietary fiber/1000 kcal, and 3.8 daily servings of fruits and vegetables. Baseline dietary characteristics, 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 behavioral 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 servings (depending on total caloric intake) of fruits and vegetables. Control participants do not receive such counseling and are expected to continue their usual intake. Dietary intake in both groups is mentioned annually using a 4-day food record (also completed at 6 months by intervention 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 for lipids and carotenoids. This article provides details on the rationale and design of the PPT dietary intervention program and describes the participant baseline dietary intake data characteristics.