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Individualized multifactorial lifestyle intervention trial for high-risk cardiovascular patients in primary care [with consumer summary]
Ketola E, Makela M, Klockars M
British Journal of General Practice 2001 Apr;51(465):291-294
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The multiprofessional teams in Finnish health centres are well placed to carry out interventions aimed at the prevention of cardiovascular diseases. AIM: To evaluate the effectiveness of an individually tailored multifactorial lifestyle intervention in primary care for individuals at high risk for cardiovascular disease. DESIGN OF STUDY: A randomised controlled trial was conducted over 24 months with interim assessments at six and 12 months. SETTING: A health centre in Finland with a patient population of 11,000. METHOD: One hundred and fifty adults aged 18 to 65 years old with existing cardiovascular disease or multiple risk factors were randomised to active multiprofessional risk factor intervention or to standard care. The main outcome measure was a change in cardiovascular risk-factor score. Secondary outcomes were changes in blood pressure, weight, body-mass index, serum cholesterol, blood glucose, smoking cessation, and exercise habits. RESULTS: The cardiovascular risk score decreased by 28% in the intervention group (23% in the control group), body weight decreased by 3.7% (2%) and total cholesterol decreased by 10.8% (6.5%), while time engaged in exercise increased by 39% (43%). Differences were not significant. CONCLUSIONS: Cardiovascular risk levels of high-risk individuals decreased in both intervention and control groups. Primary care prevention should be targeted to high-risk persons. Long-term follow-up studies are needed.

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