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One-year follow-up of a therapeutic lifestyle intervention targeting cardiovascular disease risk
Wister A, Loewen N, Kennedy-Symonds H, McGowan B, McCoy B, Singer J
Canadian Medical Association Journal [Journal de l'Association Medicale Canadienne] 2007 Oct 9;177(8):859-865
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: In this study, we tested the efficacy of a low-intensity lifestyle intervention aimed at reducing the risk of cardiovascular disease among mid-life individuals. METHODS: We conducted a randomized controlled trial in which participants were randomly assigned either to receive a health report card with counselling (from a Telehealth nurse) on smoking, exercise, nutrition and stress or to receive usual care. The patients were divided into 2 groups on the basis of risk: the primary prevention group, with a Framingham risk score of 10% or higher (intervention, n = 157; control, n = 158), and the secondary prevention group, who had a diagnosis of coronary artery disease (intervention, n = 153; control, n = 143). The primary outcome was a change in the Framingham global risk score between baseline and 1-year follow-up. Data were analyzed separately for the 2 prevention groups using an intention-to-treat analysis controlling for covariates. RESULTS: Within the primary prevention group, there were statistically significant changes for the treatment group relative to the controls, from baseline to year 1, in Framingham score (intervention, -3.10 (95% confidence interval (CI) -3.98 to -2.22); control, -1.30 (95% CI -2.18 to -0.42); p < 0.01) and scores for total cholesterol (intervention, -0.41 (95% CI -0.59 to -0.23); control, -0.14 (95% CI -0.32 to 0.04); p < 0.05), systolic blood pressure (intervention, -7.49 (95% CI -9.97 to -5.01); control, -3.58 (95% CI -6.08 to -1.08); p < 0.05), nutrition level (intervention, 0.30 (95% CI 0.13 to 0.47); control, -0.05 (95% CI -0.22 to 0.12); p < 0.01), and health confidence (intervention, 0.20 (95% CI 0.09 to 0.31); control, 0.04 (95% CI -0.07 to 0.15); p < 0.05), with adjustment for covariates. No significant changes in outcome variables were found for the secondary prevention group. INTERPRETATION: We found evidence for the efficacy of an intervention addressing multiple risk factors for primary prevention at 1 year using Framingham risk score report cards and telephone counselling.

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