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A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study.

ABSTRACT: 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.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 (-2.2 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).A program of intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals.ClinicalTrials.gov NCT00486941.

SUBMITTER: Eriksson MK

PROVIDER: S-EPMC2664964 | biostudies-literature | 2009

REPOSITORIES: biostudies-literature

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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.

Eriksson Margareta K MK Franks Paul W PW Eliasson Mats M

PloS one 20090414 4

<h4>Background</h4>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 primar ...[more]

PMID: 19365563

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Project description:BackgroundIntensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months.MethodsThe PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24.ResultsAs recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point.ConclusionsA pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.

Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

Project description:ObjectiveTo evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.DesignRandomized controlled pilot trial.SettingThree primary health care centers in southern Sweden.SubjectsSixty patients aged 40-80 years with hypertension were included.Main outcome measuresFeasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.MethodsThirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.ResultsAll feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.ConclusionLifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.

Project description:BackgroundIn this study, we tested the efficacy of a low-intensity lifestyle intervention aimed at reducing the risk of cardiovascular disease among mid-life individuals.MethodsWe 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.ResultsWithin 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.InterpretationWe 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. (Requirement for clinical trial registration waived [enrolment completed before requirement became applicable].).

Project description:Implementation of interventions concerning prevention and health promotion in health care has faced particular challenges resulting in a low frequency and quality of these services. In November 2011, the Swedish National Board of Health and Welfare released national clinical practice guidelines to counteract patients' unhealthy lifestyle habits. Drawing on the results of a previous study as a point of departure, the aim of this two-year follow up was to assess the progress of work with lifestyle interventions in primary healthcare as well as the uptake and usage of the new guidelines on lifestyle interventions in clinical practice.Longitudinal study among health professionals with survey at baseline and 2 years later. Development over time and differences between professional groups were calculated with Pearson chi-square test.Eighteen percent of the physicians reported to use the clinical practice guidelines, compared to 58% of the nurses. Nurses were also more likely to consider them as a support in their work than physicians did. Over time, health professionals usage of methods to change patients' tobacco habits and hazardous use of alcohol had increased, and the nurses worked to a higher extent than before with all four lifestyles. Knowledge on methods for lifestyle change was generally high; however, there was room for improvement concerning methods on alcohol, unhealthy eating and counselling. Forty-one percent reported to possess thorough knowledge of counselling skills.Even if the uptake and usage of the CPGs on lifestyle interventions so far is low, the participants reported more frequent counselling on patients' lifestyle changes concerning use of tobacco and hazardous use of alcohol. However, these findings should be evaluated acknowledging the possibility of selection bias in favour of health promotion and lifestyle guidance, and the loss of one study site in the follow up. Furthermore, this study indicates important differences in physicians and nurses' attitudes to and use of the guidelines, where the nurses reported working to a higher extent with all four lifestyles compared to the first study. These findings suggest further investigations on the implementation process in clinical practice, and the physicians' uptake and use of the CPGs.

Dataset Information

A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study.

Publications

A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Björknäs study.

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