OBJECTIVE: To evaluate the effect of a culturally sensitive cholesterol lowering diet program on lipid and lipoproteins, body weight, nutrient intakes, and quality of life (QOL) in patients with systemic lupus erythematosus (SLE). METHOD:Seventeen patients with SLE were randomized to a Step 2 diet intervention group or a control group for 12 weeks. The diet intervention was made up of weekly group sessions during the first 6 weeks followed by telephone counseling every 2 weeks for the last 6 weeks. Data on fasting lipid and lipoproteins, body weight, food intake (3 day food record), and QOL were collected at baseline, 6 weeks, and 12 weeks. Program acceptability was assessed in the diet group at 6 weeks. RESULTS: The intervention was found to be highly acceptable and culturally sensitive. The changes in nutrient intakes at 6 and 12 weeks in the diet group were -49% and -33%, respectively, for cholesterol, -44% and -32%, respectively, for percentage calories from fat, and -46% and -32%, respectively, for percentage calories from saturated fat. The corresponding figures in the control group were +22% and -8% for cholesterol, +9% and +6% for percentage calories from fat, and +5% and +7% for percentage calories from saturated fat. The treatment by time interaction was significant for all the dietary variables (p = 0.0003 to 0.02). QOL was reported to improve by 15-17% in the diet group and decrease by 4-6% in the control group, and the treatment by time interaction was significant (p = 0.05). The changes in the physiological variables at 6 and 12 weeks in the diet group were -10% and -6%, respectively, for total cholesterol, -10% and -2%, respectively, for low density lipoprotein (LDL) cholesterol, -11% and -4%, respectively, for high density lipoprotein (HDL) cholesterol, -25% and -34%, respectively, for very low density lipoprotein (VLDL) cholesterol, -8% and -24%, respectively, for triglycerides, and -2% and -5%, respectively, for body weight. The corresponding figures in the control group were -5% and -3% for total cholesterol, -6% and -5% for LDL cholesterol, 0% and +12% for HDL cholesterol, +4% and -8% for VLDL cholesterol, -6% and -15% for triglycerides, and -5% and -6% for body weight. The treatment by time interaction was significant for HDL cholesterol (p = 0.04). A significant reduction was seen in the diet group for total cholesterol at 6 and 12 weeks, LDL and HDL cholesterol at 6 weeks, and body weight at 12 weeks (p = 0.0002 to 0.01). CONCLUSION: This culturally sensitive cholesterol reducing diet program was highly accepted and effective in changing the diet and QOL of patients with SLE. The effect on serum lipids, lipoproteins, and body weight, however, was modest. A larger randomized study with a longer intervention period is necessary to test the effectiveness of a cholesterol-lowering diet on lipids and lipoproteins in patients with SLE.
RCT Entities:
OBJECTIVE: To evaluate the effect of a culturally sensitive cholesterol lowering diet program on lipid and lipoproteins, body weight, nutrient intakes, and quality of life (QOL) in patients with systemic lupus erythematosus (SLE). METHOD: Seventeen patients with SLE were randomized to a Step 2 diet intervention group or a control group for 12 weeks. The diet intervention was made up of weekly group sessions during the first 6 weeks followed by telephone counseling every 2 weeks for the last 6 weeks. Data on fasting lipid and lipoproteins, body weight, food intake (3 day food record), and QOL were collected at baseline, 6 weeks, and 12 weeks. Program acceptability was assessed in the diet group at 6 weeks. RESULTS: The intervention was found to be highly acceptable and culturally sensitive. The changes in nutrient intakes at 6 and 12 weeks in the diet group were -49% and -33%, respectively, for cholesterol, -44% and -32%, respectively, for percentage calories from fat, and -46% and -32%, respectively, for percentage calories from saturated fat. The corresponding figures in the control group were +22% and -8% for cholesterol, +9% and +6% for percentage calories from fat, and +5% and +7% for percentage calories from saturated fat. The treatment by time interaction was significant for all the dietary variables (p = 0.0003 to 0.02). QOL was reported to improve by 15-17% in the diet group and decrease by 4-6% in the control group, and the treatment by time interaction was significant (p = 0.05). The changes in the physiological variables at 6 and 12 weeks in the diet group were -10% and -6%, respectively, for total cholesterol, -10% and -2%, respectively, for low density lipoprotein (LDL) cholesterol, -11% and -4%, respectively, for high density lipoprotein (HDL) cholesterol, -25% and -34%, respectively, for very low density lipoprotein (VLDL) cholesterol, -8% and -24%, respectively, for triglycerides, and -2% and -5%, respectively, for body weight. The corresponding figures in the control group were -5% and -3% for total cholesterol, -6% and -5% for LDL cholesterol, 0% and +12% for HDL cholesterol, +4% and -8% for VLDL cholesterol, -6% and -15% for triglycerides, and -5% and -6% for body weight. The treatment by time interaction was significant for HDL cholesterol (p = 0.04). A significant reduction was seen in the diet group for total cholesterol at 6 and 12 weeks, LDL and HDL cholesterol at 6 weeks, and body weight at 12 weeks (p = 0.0002 to 0.01). CONCLUSION: This culturally sensitive cholesterol reducing diet program was highly accepted and effective in changing the diet and QOL of patients with SLE. The effect on serum lipids, lipoproteins, and body weight, however, was modest. A larger randomized study with a longer intervention period is necessary to test the effectiveness of a cholesterol-lowering diet on lipids and lipoproteins in patients with SLE.