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A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Björknäs study
Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Physiotherapy.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
2009 (English)In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 4, no 4, e5195- p.Article in journal (Refereed) Published
Abstract [en]

Background Successfully 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 Findings The 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 (–2.2cm: p=0.001), waist-hip ratio (–0.02: p<0.0001), systolic blood pressure (–4.9mmHg: p=0.036), and diastolic blood pressure (–1.6mmHg: 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 / Significance  A program of intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals.

Place, publisher, year, edition, pages
Public Library of Science , 2009. Vol. 4, no 4, e5195- p.
Keyword [en]
lifestyle intervention
National Category
Cardiac and Cardiovascular Systems
Research subject
Physiotherapy
Identifiers
URN: urn:nbn:se:umu:diva-31261DOI: 10.1371/journal.pone.0005195OAI: oai:DiVA.org:umu-31261DiVA: diva2:292047
Available from: 2010-02-12 Created: 2010-02-04 Last updated: 2017-12-12Bibliographically approved
In thesis
1. A 3-year lifestyle intervention in primary health care: effects on physical activity, cardiovascular risk factors, quality of life and cost-effectiveness
Open this publication in new window or tab >>A 3-year lifestyle intervention in primary health care: effects on physical activity, cardiovascular risk factors, quality of life and cost-effectiveness
2010 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: A sedentary lifestyle diminishes quality of life (QOL) and contributes to increasing prevalence of obesity, diabetes and cardiovascular diseases (CVD), and thus increases the economic burden on health care and society. Expensive and tightly controlled lifestyle interventions reduce cardiovascular risk and onset of diabetes. Transferring these findings to the primary care setting is of clinical importance. The primary aim of this thesis was to apply a lifestyle intervention program in the primary care setting among individuals with moderate-to-high risk for CVD, and evaluate the effects on physical activity, cardiovascular risk factor levels and QOL. A secondary aim was to investigate the cost-effectiveness.

Methods: A randomized controlled trial with one intervention group (n=75) and one control group (n=76) with follow-up at 3, 12, 24 and 36 months was used. Patients with the diagnosis obesity, hypertension, dyslipidemia, type 2 diabetes or any combination thereof (mean age 54 yr, 57% female) were recruited from a primary health centre in northern Sweden. The three-month intervention period consisted of group-based supervised exercise sessions and diet counselling, followed by regular, but sparse, group meetings with a behavioural approach during three years. Clinical measurements included anthropometrics, aerobic fitness, blood pressure and metabolic traits. Questionnaires on self-reported physical activity, stages of change for physical activity, and QOL were used. In a cost-utility analysis the costs, gained quality-adjusted life years (QALY), and savings in health care were considered. Probability of cost-effectiveness was described using Net Monetary Benefit Method.

Results: Overall, the lifestyle intervention generated beneficial improvements in anthropometrics, blood pressure, aerobic fitness and activity level, and QOL, compared to the control group which only received one information meeting.  At 36 months, intention-to-treat analyses showed that lifestyle modification reduced waist circumference (–2.2 cm), waist-hip ratio (–0.02), systolic blood pressure (–5.1 mmHg), and diastolic blood pressure (–1.6 mmHg) and significantly improved aerobic fitness (5%).  BMI, lipid or glucose values did not differ between groups. Progression to active stages of change for physical activity and increases in time spent exercising and total physical activity were reported. Both physical and mental dimensions of QOL were improved during the study period, but after 3 years differences persisted mainly in physical dimensions. Cost per gained QALY was low, 1668-4813 USD (savings not counted). Visits to family physicians significantly decreased and there was a net saving of 47 USD per participant. Probabilities of cost-effectiveness were 89-100% when 50 000 USD was used as threshold of willingness to pay for a gained QALY.

Conclusions: A group-based lifestyle intervention program in a primary health care setting favourably influences cardiovascular risk-factor profiles, increases physical activity level, and improves several dimensions of QOL in high-risk individuals, at least up to 3 years. The intervention method was highly cost-effective in relation to standard care. The results emphasize the advantage of an intervention that combines supervised exercise with regular follow-ups for reaching long term effects.  The study high-lights the feasibility of lifestyle interventions in the primary care setting and the importance of health care professionals supporting change in lifestyle.

Place, publisher, year, edition, pages
Umeå: Umeå university, 2010. 117 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 1333
Keyword
lifestyle intervention, primary health care, physical activity, cardiovascular risk factors, quality of life, cost-effectivenesss
National Category
Physiotherapy
Research subject
Physiotherapy
Identifiers
urn:nbn:se:umu:diva-32765 (URN)978-91-7264-953-8 (ISBN)
Public defence
2010-04-16, Aulan, konferenscenter, Sunderby sjukhus, Luleå, 13:00 (English)
Opponent
Supervisors
Available from: 2010-03-26 Created: 2010-03-25 Last updated: 2010-09-27Bibliographically approved

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Eriksson, Margareta K.Franks, Paul WEliasson, Mats

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