Abstract

BackgroundSuccessfully transferring the findings of expensive and tightly controlled programmes of intensive lifestyle modification to the primary care setting is necessary if such knowledge is to be of clinical utility. The objective of this study was to test whether intensive lifestyle modification, shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals, can reduce cardiovascular risk factor levels in the primary care setting.Methodology / Principal FindingsThe Swedish Björknäs study was a randomized controlled trial conducted from 2003 to 2006 with follow-up on cardiovascular risk factors at 3, 12, 24 and 36 months. A total of 151 middle-aged men and women at moderate- to high-risk of cardiovascular disease from northern Sweden were randomly assigned to either an intensive lifestyle intervention (n = 75) or control (n = 76) group. The intervention was based broadly on the protocol of the Diabetes Prevention Program. The three-month intervention period was administered in the primary care setting and consisted of supervised exercise sessions and diet counselling, followed by regular group meetings during three years. The control group was given general advice about diet and exercise and received standard clinical care. Outcomes were changes in anthropometrics, aerobic fitness, self-reported physical activity, blood pressure, and metabolic traits. At 36 months post-randomisation, intensive lifestyle modification reduced waist circumference (−2.2 cm: p = 0.001), waist-hip ratio (−0.02: p<0.0001), systolic blood pressure (−4.9 mmHg: p = 0.036), and diastolic blood pressure (−1.6 mmHg: p = 0.005), and improved aerobic fitness (5%; p = 0.038). Changes in lipid or glucose values did not differ statistically between groups. At 36 months, self-reported time spent exercising and total physical activity had increased more in the intervention group than in the control group (p<0.001).Conclusion / SignificanceA program of intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals.Trial RegistrationClinicalTrials.gov NCT00486941

Highlights

  • Evidence from epidemiological and experimental studies overwhelmingly illustrates the beneficial impact of healthy lifestyle behaviours on cardiovascular risk [1,2]

  • We present here the full results from the Swedish Bjorknas Study, a three year randomised controlled trial of intensive lifestyle modification for cardiovascular risk reduction in patients at moderate- to high-risk of cardiovascular disease

  • The study protocol was adapted from the Diabetes Prevention Program (DPP), but was delivered with limited resources at a primary health care centre in the northern Swedish town of Boden

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Summary

Introduction

Evidence from epidemiological and experimental studies overwhelmingly illustrates the beneficial impact of healthy lifestyle behaviours on cardiovascular risk [1,2]. The methods to promote physical activity have involved activity feedback using pedometers, activity counseling, and exercise prescription [4,5,6], or more extensive lifestyle programs such as those implemented in the Finnish Diabetes Prevention Study (DPS) [7] and the Diabetes Prevention Program (DPP) [8] These more extensive lifestyle intervention programs have been shown to induce around 5–7% weight loss and achieve clinically relevant reductions in cardiovascular risk factor levels [9,10] and delay the onset of type 2 diabetes [7,11,12] and CVD [1,2,3]. The objective of this study was to test whether intensive lifestyle modification, shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals, can reduce cardiovascular risk factor levels in the primary care setting

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