Results of a randomized feasibility study of a low-fat diet

• A 2-year randomized clinical trial was conducted to test whether free-living women aged 45 to 69 years can reduce the fat content of their diet from the typical US level of approximately 39% to 20% of energy from fat, using readily available foods, when given nutritional and behavioral counseling and social support. Three clinical units randomized 303 selected volunteers into intervention (low-fat eating plan) or control (customary diet) groups. The two groups were comparable at baseline. The intervention group received nutrition instruction and behavioral counseling largely in permanent groups of 12 to 15 participants meeting weekly, then biweekly, and finally monthly. At 6 months, they had substantially reduced the mean proportion of total energy from fat from 39.1% to 20.9%, compared with the control group's nonsignificant reduction from 39.0% to 38.1%. At 12 and 24 months, they sustained the reduction of energy from fat. Weight loss and plasma cholesterol level changes in the intervention group supported the self-recorded dietary intake changes. Attendance at intervention sessions averaged 75% during the first 6 months and, subsequently, 60% to 70%. Fourday food records for the randomized women were obtained at 6 and 12 months from approximately 95% and at 24 months from 87%. A clinical trial of a low-fat diet is feasible in women. (Arch Intern Med. 1909;150:421-427)