Background – With escalating costs of pharmaceuticals to manage cardiovascular risk factors, there is a need to develop more effective lifestyle intervention programs that can reduce the reliance on these agents.
Objectives – To evaluate the efficacy of a pilot Comprehensive Lifestyle Intervention Program (CLIP) compared with qualitative lifestyle advice (L) and Simvastatin plus qualitative lifestyle (S+L) on cardiovascular risk factors in overweight hypercholesterolaemic individuals at mild-moderate cardiovascular risk.
Design – Parallel randomised controlled trial of 6 weeks duration. Intervention groups were CLIP (n=22): structured meal plan comprising energy restriction (6MJ), fish 2meals/week, cereal high in soluble fibre, saturated fat<8% energy, wholegrain bread, nuts, 25g plant sterol margarine per day plus exercise advice and self monitoring. The
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groups were matched for total cholesterol 6.3 ± 0.8mmol/L, age 51± 9 y and BMI 32 ± 4 kg/m . L (n=22) were
provided comprehensive qualitative diet and exercise advice and S + L (n-22 received 20mg/day simvastatin plus the same advice.
Outcomes – CLIP lowered LDL cholesterol by 0.70 ± 0.73mmol/L (18%), L by 0.23 ± 0.63mmol/L (6%) and L+S by 1.5 ± 0.6mmol/L (39%) all significantly different (P<0.001). The total cholesterol/HDL ratio was only lowered by CLIP and S+L. Weight and waist circumference was significantly lowered by CLIP (-4.4 ± 2.1kg; -6.7 ± 3.9 cm) compared to L (-1.1 ± 1.7 kg; -2.6 ± 3.5 cm) and L+S (-1.0 ± 1.3 kg; -2.7 ± 2.2) P<0.001). β carotene levels increased on CLIP and L relative to S+L (P=0.001). Folate increased on CLIP only (P<0.01). CLIP was well accepted by participants.
Conclusion – CLIP is more effective than qualitative lifestyle advice in improving cardiometabolic risk factors. Although not as effective as simvastatin in lowering LDL cholesterol, this program, if sustainable, may assist in comprehensive risk factor management and delay the need for lipid lowering drugs in this group.