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A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors
Eriksson KM, Westborg CJ, Eliasson MC
Scandinavian Journal of Public Health 2006 Oct;34(5):453-461
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: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIMS: To evaluate the effects of a lifestyle intervention programme in primary healthcare, targeted to patients with moderate to high risk of cardiovascular disease in terms of cardiovascular risk factors, physical activity, and quality of life. METHOD: Randomized controlled trial with one-year follow-up, carried out in a primary healthcare centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes, or obesity were enrolled. The subjects were randomized to either the intervention (n = 75) or the control group (n = 76). A total of 123 subjects completed the one-year follow-up. INTERVENTIONS: Exercise: supervised endurance and circuit training in groups three times a week for three months. Diet: five group sessions of diet counselling with a dietitian. Follow- up meetings with a physiotherapist were conducted monthly thereafter. Primary outcomes were changes in anthropometry, maximal oxygen uptake, health-related quality of life, and self-reported physical activity. The secondary outcomes were changes in blood pressure and metabolic variables. RESULTS: After one year the intervention group significantly increased maximal oxygen uptake, physical activity, and quality of life and significantly decreased body weight, waist and hip circumference, body mass index, waist-hip ratio, systolic and diastolic blood pressure, triglycerides, and glycosylated haemoglobin. There were significant differences between groups, mean changes (and their 95% confidence intervals, CI) in waist circumference -1.9 cm (-2.80 to -0.90; p < 0.001), in waist-hip ratio -0.01 (-0.02 to -0.004; p < 0.01) and in diastolic blood pressure -2.3 mmHg (-4.04 to -0.51; p < 0.05). CONCLUSION: A prevention programme in primary healthcare with a focus on physical activity and diet counselling followed by structured follow-up meetings can favourably influence several risk factors for cardiovascular diseases and quality of life in high-risk subjects for at least one year.

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