title: A Comprehensive Lifestyle Intervention to Prevent Type 2 Diabetes and Cardiovascular Diseases: the German CHIP Trial Randomized controlled trial on cardiovascular risk management by practice nurses supported by self-monitoring in primary care Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial Cardiovascular risk management and its impact on hypertension control in primary care in low-resource settings: a cluster-randomized trial. Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study. Family Heart Study Group. A 3-Year Randomized Trial of Lifestyle Intervention for Cardiovascular Risk Reduction in the Primary Care Setting: The Swedish Björknäs Study The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials The Tromsø Survey: the Family Intervention study--the effect of intervention on some coronary risk factors and dietary habits, a 6-year follow-up. Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study Combined Impact of Health Behaviours and Mortality in Men and Women: The EPIC-Norfolk Prospective Population Study Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up Is a targeted and planned GP intervention effective in cardiovascular disease prevention? A randomized controlled trial Results of the Heart Healthy and Ethnically Relevant Lifestyle trial: a cardiovascular risk reduction intervention for African American women attending community health centers. Life style changes improve insulin resistance in hyperinsulinaemic subjects: a one-year intervention study of hypertensives and normotensives in Dalby. Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial The impact of health care advice given in primary care on cardiovascular risk. CELL Study Group. Cardiac rehabilitation after myocardial infarction. Combined experience of randomized clinical trials. The effect of intensified diet counseling on the diet of hypertensive subjects in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland. Behavioural counselling in general practice for the promotion of healthy behaviour among adults at increased risk of coronary heart disease: randomised trial. Effectiveness of two preventive interventions for coronary heart disease in primary care. Predicting the 10 year risk of cardiovascular disease in the United Kingdom: independent and external validation of an updated version of QRISK2 Multiple significance tests: the Bonferroni method. Beneficial effects of short-term nutritional counselling at the primary health-care level among Brazilian adults. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial Framework for design and evaluation of complex interventions to improve health Cardiovascular prevention in the Hartslag Limburg project: effects of a high-risk approach on behavioral risk factors in a general practice population.
abstract: The prevalence of type 2 diabetes is continuously increasing . This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system . In view of the fact that type 2 diabetes is primarily caused by behavioral factors , effective preventive strategies are urgently needed . We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes . We conducted a r and omized controlled trial in a primary care setting in Hannover , Germany , with 83 patients diagnosed as (pre)diabetic or at risk for diabetes . CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases . The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach . The primary outcome parameter was the body mass index ( BMI ) . Secondary outcome parameters included body weight , blood pressure , fasting glucose , HbA1c , blood lipids , and the FINDRISK score , which assesses long-term diabetes risk . At the final measurement after 12 months , in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m2 in controls ( p = .119 ) . The mean sustained weight loss after 12 months was −4.1 kg in the intervention group versus −0.8 kg in controls . Furthermore , we found a trend toward a stronger reduction in blood pressure , fasting glucose , and HbA1c as well as an improved FINDRISK score in the intervention group , compared to controls . Although failing to reach statistical significance at the final assessment , this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes Background Treatment goals for cardiovascular risk management are generally not achieved . Specialized practice nurses are increasingly facilitating the work of general practitioners and self-monitoring devices have been developed as counseling aid . The aim of this study was to compare st and ard treatment supported by self-monitoring with st and ard treatment without self-monitoring , both conducted by practice nurses , on cardiovascular risk and separate risk factors . Methods Men aged 50–75 years and women aged 55–75 years without a history of cardiovascular disease or diabetes , but with a SCORE 10-year risk of cardiovascular mortality ≥5 % and at least one treatable risk factor ( smoking , hypertension , lack of physical activity or overweight ) , were r and omized into two groups . The control group received st and ard treatment according to guidelines , the intervention group additionally received pro-active counseling and self-monitoring ( pedometer , weighing scale and / or blood pressure device ) . After one year treatment effect on 179 participants was analyzed . Results SCORE risk assessment decreased 1.6 % ( 95 % CI 1.0–2.2 ) for the control group and 1.8 % ( 1.2–2.4 ) for the intervention group , difference between groups was .2 % ( −.6–1.1 ) . Most risk factors tended to improve in both groups . The number of visits was higher and visits took more time in the intervention group ( 4.9 ( SD2.2 ) vs. 2.6 ( SD1.5 ) visits p < .001 and 27 ( P25 –P75:20–33 ) vs. 23 ( P25 –P75:19–30 ) minutes/visit p = .048 ) . Conclusions In both groups cardiovascular risk decreased significantly after one year of treatment by practice nurses . No additional effect of basing the pro-active counseling on self-monitoring was found , despite the extra time investment . Trial registration trialregister.nl Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities .  Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities OBJECTIVE To measure the change in cardiovascular risk factors achievable in families over one year by a cardiovascular screening and lifestyle intervention in general practice . DESIGN R and omised controlled trial in 26 general practice s in 13 towns in Britain . SUBJECTS 12,472 men aged 40 - 59 and their partners ( 7460 men and 5012 women ) identified by household . INTERVENTION Nurse led programme using a family centred approach with follow up according to degree of risk . MAIN OUTCOME MEASURES After one year the pairs of practice s were compared for differences in ( a ) total coronary ( Dundee ) risk score and ( b ) cigarette smoking , weight , blood pressure , and r and om blood cholesterol and glucose concentrations . RESULTS In men the overall reduction in coronary risk score was 16 % ( 95 % confidence interval 11 % to 21 % ) in the intervention practice s at one year . This was partitioned between systolic pressure ( 7 % ) , smoking ( 5 % ) , and cholesterol concentration ( 4 % ) . The reduction for women was similar . For both sexes reported cigarette smoking at one year was lower by about 4 % , systolic pressure by 7 mm Hg , diastolic pressure by 3 mm Hg , weight by 1 kg , and cholesterol concentration by 0.1 mmol/l , but there was no shift in glucose concentration . Weight , blood pressure , and cholesterol concentration showed the greatest difference at the top of the distribution . If maintained long term the differences in risk factors achieved would mean only a 12 % reduction in risk of coronary events . CONCLUSIONS As most general practice s are not using such an intensive programme the changes in coronary risk factors achieved by the voluntary health promotion package for primary care are likely to be even smaller . The government 's screening policy can not be justified by these results 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 r and omized 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 r and omly 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 st and ard clinical care . Outcomes were changes in anthropometrics , aerobic fitness , self-reported physical activity , blood pressure , and metabolic traits . At 36 months post-r and omisation , 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 / 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 . Trial Registration Clinical Trials.gov Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more While most intervention studies on coronary heart disease have focused on the high-risk person only , the present study used the family as the unit of intervention . In the study 1373 high-risk men , ages 30 - 54 years , were identified on the basis of high total cholesterol ( TC ) and /or low relative high-density lipoprotein cholesterol ( HDL-C ) ( HDL-C/TC ) following the 1979/1980 survey in Tromsø . The men and their families were r and omly allocated to a control or intervention condition . The intervention families were given advice on diet , smoking , and exercise . At rescreening in 1986/1987 , significantly lower risk factor levels were found in both the intervention men and their spouses compared with those in the control group . For children , the differences were small and mostly nonsignificant . Men , spouses , and children in the intervention group reported more favorable dietary habits than those in the control group . No differences were found in smoking or leisure time physical activity Abstract Objective : To determine the effectiveness of health checks , performed by nurses in primary care , in reducing risk factors for cardiovascular disease and cancer . Design : R and omised controlled trial . Setting : Five urban general practice s in Bedfordshire . Subjects : 2205 men and women who were r and omly allocated a first health check in 1989 - 90 and a re-examination in 1992 - 3 ( the intervention group ) ; 1916 men and women who were r and omly allocated an initial health check in 1992 - 3 ( the control group ) . All subjects were aged 35 - 64 at recruitment in 1989 . Main outcome measures : Serum total cholesterol concentration , blood pressure , body mass index , and smoking prevalence ( with biochemical validation of cessation ) ; self reported dietary , exercise , and alcohol habits . Results : Mean serum total cholesterol was 3.1 % lower in the intervention group than controls ( difference 0.19 mmol/l ( 95 % confidence interval 0.12 to 0.26 ) ; in women it was 4.5 % lower ( P<0.0001 ) and in men 1.6 % ( P<0.05 ) , a significant difference between the sexes ( P<0.01 ) . Self reported saturated fat intake was also significantly lower in the intervention group . Systolic and diastolic blood pressures and body mass index were respectively 1.9 % , 1.9 % , and 1.4 % lower in the intervention group ( P<0.005 in all cases ) . There was a 3.9 % ( 2.4 to 5.3 ) difference in the percentage of subjects with a cholesterol concentration > /=8 mmol/l , but no significant differences in the number with diastolic blood pressure > /=100 mm Hg or body mass index > /=30 kg/m2 . There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use . Annual rechecks were no more effective than a single recheck at three years , but health checks led to a significant increase in visits to the nurse according to patients ' degree of cardiovascular risk . Conclusions : The benefits of health checks were sustained over three years . The main effects were to promote dietary change and reduce cholesterol concentrations ; small differences in blood pressure may have been attributable to accommodation to measurement . The benefits of systematic health promotion in primary care are real , but must be weighed against the costs in relation to other priorities . Key messages Key messages There is little effect on smoking or alcohol use , and more targeted approaches to modifying these behaviours may be appropriate Systematic implementation of health checks might lead to a reduction in risk of myocardial infa rct ion among those who attend of about 5 - 15 % ; men , who are at higher risk , show less change than women Health checks consume substantial re sources , and their effect is attenuated by non-attendance The benefits of health promotion through primary care must be weighed against their costs and in relation to other Background There is overwhelming evidence that behavioural factors influence health , but their combined impact on the general population is less well documented . We aim ed to quantify the potential combined impact of four health behaviours on mortality in men and women living in the general community . Methods and Findings We examined the prospect i ve relationship between lifestyle and mortality in a prospect i ve population study of 20,244 men and women aged 45–79 y with no known cardiovascular disease or cancer at baseline survey in 1993–1997 , living in the general community in the United Kingdom , and followed up to 2006 . Participants scored one point for each health behaviour : current non-smoking , not physically inactive , moderate alcohol intake ( 1–14 units a week ) and plasma vitamin C > 50 mmol/l indicating fruit and vegetable intake of at least five servings a day , for a total score ranging from zero to four . After an average 11 y follow-up , the age- , sex- , body mass– , and social class – adjusted relative risks ( 95 % confidence intervals ) for all-cause mortality(1,987 deaths ) for men and women who had three , two , one , and zero compared to four health behaviours were respectively , 1.39 ( 1.21–1.60 ) , 1.95 ( 1.70–-2.25 ) , 2.52 ( 2.13–3.00 ) , and 4.04 ( 2.95–5.54 ) p < 0.001 trend . The relationships were consistent in subgroups stratified by sex , age , body mass index , and social class , and after excluding deaths within 2 y. The trends were strongest for cardiovascular causes . The mortality risk for those with four compared to zero health behaviours was equivalent to being 14 y younger in chronological age . Conclusions Four health behaviours combined predict a 4-fold difference in total mortality in men and women , with an estimated impact equivalent to 14 y in chronological age Background Intensive diet and physical activity interventions have been found to reduce cardiovascular disease ( CVD ) risk , but are re source intensive . The American Heart Association recently recommended motivational interviewing ( MI ) as an effective approach for low-intensity interventions to promote health-related outcomes such as weight loss . However , there is limited research evaluating the long-term effectiveness of MI-based interventions on health-related outcomes associated with CVD risk . The current research evaluated the effectiveness of a six-month low-intensity MI intervention in a UK primary -care setting in maintaining reductions in CVD risk factors at12 months post-intervention . Methods Primary -care patients were r and omised to an intervention group that received st and ard exercise and nutrition information plus up to five face-to-face MI sessions , delivered by a physical activity specialist and registered dietician over a 6-month period , or to a minimal intervention comparison group that received the st and ard information only . Follow-up measures of behavioural ( vigorous and moderate physical activity , walking , physical activity stage-of-change , fruit and vegetable intake , and dietary fat intake ) and biomedical ( weight , body mass index [ BMI ] , blood pressure , cholesterol ) outcomes were taken immediately post-intervention and at a 12-month follow-up occasion . Results Intent-to-treat analyses revealed significant differences between groups for walking and cholesterol .  Obese and hypercholesterolemic patients at baseline exhibited significant improvements in BMI and cholesterol respectively among those allocated to the intervention group compared to the comparison group . Post-intervention improvements in other health-related outcomes including blood pressure , weight , and BMI were not maintained . Conclusions The present study suggests that a low-intensity MI counselling intervention is effective in bringing about long-term changes in some , but not all , health-related outcomes ( walking , cholesterol levels ) associated with CVD risk . The intervention was particularly effective for patients with elevated levels of CVD risk factors at baseline . Based on these findings future interventions should be conducted in a primary care setting and target patients with high risk of CVD . Future research should investigate how the long-term gains in health-related outcomes brought about by the MI-counselling intervention in the current study could be extended to a wider range of health outcomes Background The optimal intensity and duration of the intervention to achieve sustained risk reduction in patients at high and very high cardiovascular ( CV ) risk still need to be established . The aim of this study was to evaluate the impact of general practitioner ’s ( GP ’s ) systematic and planned intervention on total CV risk reduction and a change in individual CV risk factors . Material / Methods This was a cluster-r and omized trial ( IS RCT N31857696 ) including 64 practice s and 3245 patients aged ≥40 . The participating GPs and their examinees were r and omized into an intervention or to a control group ( st and ard care ) . Intervention group practitioners followed up their examinees during 1 , 3 , 6 , 12 , and 18 months . The main outcome measures were change in proportion of patients with low , moderate , high , and very high CV risk , and change in individual CV risk factors from the first to the second registration . Results The proportion of patients with very high CV risk was lower in the intervention group , the same as of patients with high blood pressure , total and LDL cholesterol , and increased intake of alcohol . The mean systolic ( −1.49 mmHg ) and diastolic ( −1.57 mmHg ) blood pressure , triglycerides ( −0.18 mmol/L ) , body mass index ( −0.22 ) , and waist ( −0.4 cm ) and hip circumference ( −1.08 cm ) was reduced significantly in the intervention group . There was no additional impact in the intervention group of other tested CV risk factors . Conclusions Systematic and planned GP ’s intervention in CVD prevention reduces the number of patients with very high total CV risk and influences a change in lifestyle habits OBJECTIVES We evaluated a theory-based lifestyle intervention targeting physical activity and dietary fat intake among African American women at high risk for cardiovascular disease . METHODS The Heart Healthy and Ethnically Relevant Lifestyle trial ( 2005 - 2008 ) r and omly assigned 266 low-income African American women aged 35 years and older who were patients of South Carolina community health care centers into comprehensive or st and ard care interventions . Comprehensive participants received st and ard care ( stage-matched provider counseling and assisted goal setting ) plus 12 months of telephone counseling and tailored newsletters . Primary outcomes were 6- and 12-month self-reported physical activity and dietary fat intake . RESULTS Comprehensive participants were more likely than were st and ard care participants to decrease total physical activity ( odds ratio [ OR ] = 3.13 ; 95 % confidence interval [ CI ] = 1.18 , 8.25 ) and increase leisure-time physical activity ( OR = 3.82 ; 95 % CI = 1.41 , 10.3 ) at 6 months ( no 12-month differences ) . Mean reductions in Dietary Risk Assessment score occurred in both groups but were greater among comprehensive participants than among st and ard care participants ( 6 months , -8.50 vs -5.34 ; 12 months , -7.16 vs -3.37 ; P < .001 ) . CONCLUSIONS The comprehensive intervention improved women 's leisure-time physical activity and dietary fat intake , highlighting a replicable model to help primary care providers implement lifestyle counseling OBJECTIVE Insulin resistance and hyperinsulinaemia are , in some prospect i ve studies , linked to an increased cardiovascular risk , at least in men . We tested the hypothesis that hyperinsulinaemia may be reduced by non-pharmacological methods independently of other cardiovascular risk factors . DESIGN In a non-pharmacological intervention study for 1 year three groups of subjects ( hypertensives as well as normotensives ) were selected after stratification for insulin level at baseline . Half of the hyperinsulinaemic subjects were r and omly assigned to active intervention with physical exercise and dietary regulation ( HI-A group ) , the other half were followed passively during the study period ( HI-P group ) . Normo-insulinaemics and hypo(low)-insulinaemics also underwent active intervention ( NI-A and LI-A groups , respectively ) . SETTING Primary health care in Sweden . RESULTS During the 1-year follow-up subjects in the HI-A group reduced their weight , waist : hip ratio and systolic and diastolic blood pressure , as well as their low : high-density lipoprotein (LDL : HDL)-cholesterol ratio . Glucose levels before and during an oral glucose tolerance test did not change . However , plasma insulin and plasma-C-peptide decreased both in the fasting state and after 1 and 2 h of oral glucose tolerance testing . This decrease was independent of the previously mentioned reduction in weight , waist : hip ratio , blood pressure and LDL : HDL-cholesterol ratio . No reduction in insulin levels was seen in the HI-P , NI-A or LI-A groups , but in the HI-P group there was a slight decrease in fasting plasma-C-peptide levels . In the HI-A group dietary improvements were observed during the study period , with a reduction in energy intake , fat consumption and cholesterol intake . Fibre intake was increased . No major changes were seen in the HI-P group . CONCLUSIONS We conclude that in hypertensive and normotensive subjects with hyperinsulinaemia insulin levels can be reduced by active non-pharmacological treatment for 1 year without altering glucose tolerance . This shows that insulin resistance may be lowered by non-pharmacological treatment , which may be of considerable importance , and not only for hypertensives Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences OBJECTIVE To evaluate the additional benefit of " intensive " health care advice through six group sessions , compared with the advice usually offered to subjects with multiple risk factors for cardiovascular disease . DESIGN Prospect i ve , r and omised controlled clinical study lasting 18 months . SETTING 681 subjects aged 30 - 59 years , with at least two cardiovascular risk factors in addition to moderately high lipid concentrations : total cholesterol > or = 6.5 mmol/l on three occasions , triglycerides < 4.0 mmol/l , and ratio of low density lipoprotein cholesterol to high density lipoprotein cholesterol > 4.0 . Most ( 577 ) of the subjects were men . MAIN OUTCOME MEASURE Percentage reduction in total cholesterol concentration ( target 15 % ) ; quantification of the differences between the two types of  health care advice  ( intensive v usual ) for the Framingham cardiovascular risk and for individual risk factors . RESULTS In the group receiving intensive health care advice  total cholesterol concentration decreased by 0.15 mmol/l more ( 95 % confidence interval 0.04 to 0.26 ) than in the group receiving usual advice . The overall Framingham risk dropped by 0.068 more ( 0.014 to 0.095 ) in the group receiving intensive advice , and most of the risk factors showed a greater change in a favourable direction in this group than in the group receiving usual advice , but the differences were seldom significant . The results from question naires completed at the group sessions showed that the subjects improved their lifestyle and diet . CONCLUSION Limited additional benefit was gained from being in the group receiving the intensive health care advice . It is difficult to make an important impact on cardiovascular risk in primary care by using only the practice staff . Better methods of communicating the messages need to be devised R and omized clinical trials of cardiac rehabilitation following myocardial infa rct ion have typically demonstrated a lower mortality in treated patients , but with a statistically significant reduction in only one trial . To overcome the problem of not being able to detect small but clinical ly important benefits in mortality in r and omized clinical trials of exercise and risk factor rehabilitation after myocardial infa rct ion with small numbers of patients , we carried out a meta- analysis on the combined results of ten r and omized clinical trials that included 4347 patients ( control , 2145 patients ; rehabilitation , 2202 patients ) . The pooled odds ratios of 0.76 ( 95 % confidence intervals , 0.63 to 0.92 ) for all-cause death and of 0.75 ( 95 % confidence intervals , 0.62 to 0.93 ) for cardiovascular death were significantly lower in the rehabilitation group than in the control group , with no significant difference for nonfatal recurrent myocardial infa rct ion . These results suggest that , for appropriately selected patients , comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infa rct ion BACKGROUND Diet is an essential part of the nonpharmacological management of hypertension . The aim of this study was to investigate in a primary health care setting the effect of intensified diet counseling on the diet of hypertensive subjects . METHODS A total of 715 free-living subjects , ages 25 - 74 years , with systolic blood pressure 140 - 179 mm Hg and /or diastolic blood pressure 90 - 109 mm Hg and /or drug treatment for hypertension participated in an open r and omized trial with a 2-year follow-up at health centers in eastern Finl and . The intervention group ( n = 360 ) was advised to reduce their total fat , saturated fat , and salt intake and to increase monounsaturated and polyunsaturated fat intake as well as to reduce weight and to use alcohol in moderation if at all . The usual care group ( n = 355 ) continued with their usual primary health care . The subjects filled out a 4-day food record , and 24-h urine sample s were collected at baseline and at 1- and 2-year examinations . RESULTS The 2-year net changes ( change in intervention minus change occurring in usual care group ) in total fat intake [ -2.7 E% ( 95 % CI -4.0 , -1.6 ; P < 0.0005 ) ] , in saturated fatty acid intake [ -1.7 E% ( 95 % CI -2.3 , -1.1 ; P < 0.0005 ) ] , and in body weight [ -1.4 kg ( 95 % CI -2.0 , -0.8 ; P < 0.0005 ) ] were significant . Furthermore , the 2-year net change in daily sodium intake was significant , -9 mmol ( 95 % CI -17 , -2 ; P = 0.021 ) , but the 24-h urinary sodium excretion showed no difference between the study groups . CONCLUSION The intensified diet counseling in primary health care result ed in dietary changes interpreted as being of benefit in the long-term treatment of hypertension and prevention of atherosclerotic vascular diseases Abstract Objective : To measure the effect of behaviourally oriented counselling in general practice on healthy behaviour and biological risk factors in patients at increased risk of coronary heart disease . Design : Cluster r and omised controlled trial . Participants : 883 men and women selected for the presence of one or more modifiable risk factors : regular cigarette smoking , high serum cholesterol concentration ( 6.5 - 9.0 mmol/l ) , and high body mass index ( 25 - 35 ) combined with low physical activity . Intervention : Brief behavioural counselling , on the basis of the stage of change model , carried out by practice nurses to reduce smoking and dietary fat intake and to increase regular physical activity . Main outcome measures : Question naire measures of diet , exercise , and smoking habits , and blood pressure , serum total cholesterol concentration , weight , body mass index , and smoking cessation ( with biochemical validation ) at 4 and 12 months . Results : Favourable differences were recorded in the intervention group for dietary fat intake , regular exercise , and cigarettes smoked per day at 4 and 12 months . Systolic blood pressure was reduced to a greater extent in the intervention group at 4 but not at 12 months No differences were found between groups in changes in total serum cholesterol concentration , weight , body mass index , diastolic pressure , or smoking cessation . Conclusions : Brief behavioural counselling by practice nurses led to improvements in healthy behaviour . More extended counselling to help patients sustain and build on behaviour changes may be required before differences in biological risk factors emerge OBJECTIVES 1 . To compare a patient-centred , self-directive intervention with conventional care ; 2 . To evaluate longitudinal within-group changes of coronary heart disease risk . METHODS Risk factor changes were evaluated in 110 men with high coronary heart disease risk attending a one year intervention study in general practice . The 22 participating general practice centres were r and omly allocated to follow either a patient-centred , self-directive intervention or a conventional approach . RESULTS No significant between-group differences were found in any single risk factor or in the combined risk of coronary heart disease . The improvement of total risk from screening time to conclusion of the study corresponded with changes of relative risks of CHD to 0.64 ( 95 % CI : 0.54 - 0.77 ) and 0.65 ( 0.54 - 0.77 ) in the patient-centred , self-directive and the conventional care group respectively ( p < 0.0001 in both groups ) . CONCLUSION Everyday general practice clinical work seems as efficacious as a specific intervention method based on currently advocated behaviour change principles Objective To evaluate the performance of the QRISK2 - 2011 score for predicting the 10 year risk of cardiovascular disease in an independent UK cohort of patients from general practice and to compare it with earlier versions of the model and a National Institute for Health and Clinical Excellence version of the Framingham equation . Design Prospect i ve cohort study to vali date a cardiovascular risk score with routinely collected data between June 1994 and June 2008 . Setting 364 practice s from the United Kingdom contributing to The Health Improvement Network ( THIN ) data base . Participants Two million patients aged 30 to 84 years ( 11.8 million person years ) with 93 564 cardiovascular events . Main outcome measure First diagnosis of cardiovascular disease ( myocardial infa rct ion , angina , coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records . Results Results from this independent and external validation of QRISK2 - 2011 indicate good performance data when compared with the NICE version of the Framingham equation . QRISK2 - 2011 had better ability to identify those at high risk of developing cardiovascular disease than did the NICE Framingham equation . QRISK2 - 2011 is well calibrated , with reasonable agreement between observed and predicted outcomes , whereas the NICE Framingham equation seems to consistently over-predict risk in men by about 5 % and shows poor calibration in women . Conclusions QRISK2 - 2011 seems to be a useful model , with good discriminative and calibration properties when compared with the NICE version of the Framingham equation . Furthermore , based on current high risk thresholds , concerns exist on the clinical usefulness of the NICE version of the Framingham equation for identifying women at high risk of developing cardiovascular disease . At current thresholds the NICE version of the Framingham equation has no clinical benefit in either men or women Many published papers include large numbers of significance tests . These may be difficult to interpret because if we go on testing long enough we will inevitably find something which is “ significant . ” We must beware of attaching too much importance to a lone significant result among a mass of non-significant ones . It may be the one in 20 which we expect by chance alone . Lee et al simulated a clinical trial of the treatment of coronary artery disease by allocating 1073 patient records from past cases  into two “ treatment ” groups at r and om.1 They then analysed the outcome as if it were a genuine trial of two treatments . The analysis was quite detailed and thorough . As we would expect , it failed to show any significant difference in survival between those patients allocated to the two treatments . Patients were then subdivided by two variables which affect prognosis , the number of diseased coronary vessels and whether the left ventricular contraction pattern was normal or abnormal . A significant difference in survival between the two “ treatment ” groups was found in those patients with three diseased vessels ( the maximum ) and abnormal ventricular contraction . As this would be the subset of patients with the worst prognosis , the finding would be easy to account for by saying that the superior “ treatment ” OBJECTIVE To evaluate the impact of a low-cost nutritional intervention in changing the lifestyle of adults . DESIGN R and omised clinical trial . SETTING Primary health-care centre in São José do Rio Preto , São Paulo State , Brazil . SUBJECTS We r and omly assigned 104 adults ( 83 women and 21 men aged 30 - 65 years , body mass index 24 - 35 kg m(-2 ) , non-diabetic ) into two groups : nutrition counselling and control . Each subject in the intervention group received three individualised nutritional counselling sessions during the first 6 months aim ed at increasing intakes of fruits , vegetables and olive oil , reducing saturated fat and improving physical activity .  Body composition , biochemical indicators and lifestyle were assessed at baseline and at 6 months and 1 year in both groups . RESULTS After 6 months of follow-up , body weight , waist circumference , diastolic blood pressure , fasting blood glucose , total and low-density lipoprotein cholesterol , total and saturated fat , and dietary energy and cholesterol levels showed a more significant decrease among subjects in the intervention group than in the control group ( P < 0.05 ) . Moreover , the intervention group showed significantly greater improvement in each intervention goal , such as reduced intake of saturated fat and increased intakes of fruits , vegetables , fibre and olive oil ( P < 0.05 ) . After 12 months of follow-up , most of the outcomes were maintained . CONCLUSIONS The low-cost nutritional intervention programme improved serum lipids profile and weight control , and appeared to be feasible for use at a primary health-care centre in a developing country Objective To assess whether non- clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies . Design Pragmatic , multicentre , r and omised controlled trial . Setting 42 general practice s in three areas of Engl and . Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20 % or more , no previous cardiovascular event , at least one modifiable risk factor ( systolic blood pressure ≥140 mm Hg , body mass index ≥30 , current smoker ) , and access to a telephone , the internet , and email . Participants were individually allocated to intervention ( n=325 ) or control ( n=316 ) groups using automated r and omisation stratified by site , minimised by practice and baseline risk score . Interventions Intervention was the Healthlines service ( alongside usual care ) , comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software . Advisors facilitated self management by supporting participants to use online re sources to reduce risk factors , and sought to optimise drug use , improve treatment adherence , and encourage healthier lifestyles . The control group comprised usual care alone . Main outcome measures The primary outcome was the proportion of participants responding to treatment , defined as maintaining or reducing their cardiovascular risk after 12 months . Outcomes were collected six and 12 months after r and omisation and analysed masked . Participants were not masked . Results 50 % ( 148/295 ) of participants in the intervention group responded to treatment compared with 43 % ( 124/291 ) in the control group ( adjusted odds ratio 1.3 , 95 % confidence interval 1.0 to 1.9 ; number needed to treat=13 ) ; a difference possibly due to chance ( P=0.08 ) . The intervention was associated with reductions in blood pressure ( difference in mean systolic −2.7 mm Hg ( 95 % confidence interval −4.7 to −0.6 mm Hg ) , mean diastolic −2.8 ( −4.0 to −1.6 mm Hg ) ; weight −1.0 kg ( −1.8 to −0.3 kg ) , and body mass index −0.4 ( −0.6 to −0.1 ) but not cholesterol −0.1 ( −0.2 to 0.0 ) , smoking status ( adjusted odds ratio 0.4 , 0.2 to 1.0 ) , or overall cardiovascular risk as a continuous measure ( −0.4 , −1.2 to 0.3 ) ) . The intervention was associated with improvements in diet , physical activity , drug adherence , and satisfaction with access to care , treatment received , and care coordination . One serious related adverse event occurred , when a participant was admitted to hospital with low blood pressure . Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk , and there was no overall improvement in average risk . The Healthlines service was , however , associated with improvements in some risk behaviours , and in perceptions of support and access to care . Trial registration Current Controlled Trials IS RCT N 27508731 R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community BACKGROUND This study describes a general- practice -based high-risk cardiovascular prevention approach in Maastricht , The Netherl and s ( 1999 - 2003 ) . The intervention consisted of a complete registration of risk factors , optimization of medical treatment and health counseling on high fat consumption , smoking and physical inactivity . METHODS Behavioral effects were assessed in a trial , r and omization by practice and usual care as control . Vali date d question naires were completed by 1300 patients at baseline , 1174 after 4 months ( 90.3 % ) and 1046 ( 80.5 % ) after 18 months . RESULTS After 4 months , intention-to-treat analyses revealed a decrease in saturated fat intake of 1.3 points ( scale ranging from 7 to 30 points , p=0.000 ) . This was partly sustained after 18 months ( -0.5 points , p=0.014 ) . After 18 months , obese intervention patients were more likely to be sufficiently physically active than their control counterparts ( OR=1.90 , p=0.023 ) . No intervention effects were found for smoking . CONCLUSION Given the multiple factor and multiple component high-risk approach , the intervention had modest effects on only some of the behavioral risk factors addressed . Process data showed that the registration of risk factors and the optimization of medical treatment were only partly implemented , that the health counseling component could be further improved and that the intervention could benefit from additional health promoting strategies
target: Pooled net change in systolic blood pressure ( 16 trials ) was -1.86 ( 95 % CI -3.17 to -0.55 ; p=0.01 ) mm Hg ; diastolic blood pressure ( 15 trials ) , -1.53 ( -2.43 to -0.62 ; p=0.001 ) mm Hg ; body mass index ( 14 trials ) , -0.13 ( -0.26 to -0.01 ; p=0.04 ) kg/m2 ; serum total cholesterol ( 14 trials ) , -0.13 ( -0.19 to -0.07 ; p<0.001 ) mmol/L. There was no significant association between interventions with a reported theoretical basis and improved intervention outcomes .
  No association was observed between intervention intensity ( number of sessions and intervention duration ) and intervention outcomes .
  MHBC interventions delivered to CVD-free participants in primary care did not appear to have quantitatively important effects on CVD risk factors .
background: BACKGROUND It is uncertain whether multiple health behaviour change ( MHBC ) interventions are effective for the primary prevention of cardiovascular disease ( CVD ) in primary care .