BACKGROUND: Lifestyle interventions reduce cardiovascular risk and risk of diabetes mellitus, but reports on long-term effects on quality of life (QOL) and health care utilization are rare. We investigated the impact of a primary health care-based lifestyle intervention program on QOL and cost-effectiveness over 3 years. METHODS: A total of 151 men and women, aged 18 to 65 years, at moderate to high risk for cardiovascular disease, were randomly assigned to either lifestyle intervention with standard care or standard care alone. Intervention consisted of supervised exercise sessions and diet counseling for 3 months, followed by regular group meetings over a 3-year period. Change in QOL was measured with EuroQol (5-dimensional EuroQol-5D (EQ-5D) and EuroQol-VAS (EQ-VAS)), the 36-Item Short-Form Health Survey (SF-36), and the 6-dimensional Short-Form 6D (SF-6D). The health economic evaluation was performed from a societal view and a treatment perspective. In a cost-utility analysis, the costs, gained quality-adjusted life-years (QALYs), and savings in health care were considered. Cost-effectiveness was also described using the net monetary benefit method. RESULTS: Significant differences between the groups over the 3-year period were shown in the EQ-VAS (p = 0.002), SF-6D (p = 0.01), and SF-36 (p = 0.04) physical component summary but not in the EQ-5D (p = 0.24) or SF-36 (p = 0.37) mental component summary. The net savings were $47 per participant. Costs per gained QALY, savings not counted, were $1,668 to $4,813. Probabilities of cost-effectiveness were 89% to 100% when the amount of $50,000 was used as stakeholder's threshold of willingness to pay for a gained QALY. CONCLUSION: Lifestyle intervention in primary care improves QOL and is highly cost-effective in relation to standard care. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00486941.

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