Systematic Review of the Effect of Diet and Exercise Lifestyle Interventions in the Secondary Prevention of Coronary Heart Disease Influence on lifestyle measures and five-year coronary risk by a comprehensive lifestyle intervention programme in patients with coronary heart disease Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour A pharmacist-led follow-up program for patients with established coronary heart disease in North Norway – a randomized controlled trial The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Secondary prevention clinics for coronary heart disease: a 10-year follow-up of a randomised controlled trial in primary care The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411] Enhancing support for health behavior change among women at risk for heart disease: the Mediterranean Lifestyle Trial. Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol The effect of a smartphone-based coronary heart disease prevention (SBCHDP) programme on awareness and knowledge of CHD, stress, and cardiac-related lifestyle behaviours among the working population in Singapore: a pilot randomised controlled trial Community-based comprehensive lifestyle programs in patients with coronary artery disease: Objectives, design and expected results of Randomized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 trial (RESPONSE 2). Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial Implications of small reductions in diastolic blood pressure for primary prevention. Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial Representation of elderly persons and women in published randomized trials of acute coronary syndromes. Effects of the mediterranean lifestyle program on multiple risk behaviors and psychosocial outcomes among women at risk for heart disease Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. Integrating depression and chronic disease care among patients with diabetes and/or coronary heart disease: the design of the TEAMcare study. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study. Community-Based Lifestyle Intervention in Patients With Coronary Artery Disease: The RESPONSE-2 Trial.
The effectiveness of lifestyle interventions within secondary prevention of coronary heart disease ( CHD ) remains unclear . This systematic review aim ed to determine their effectiveness and included r and omized controlled trials of lifestyle interventions , in primary care or community setting s , with a minimum follow-up of three months , published since 1990 . 21 trials with 10,799 patients were included ; the interventions were multifactorial ( 10 ) , educational ( 4 ) , psychological ( 3 ) , dietary ( 1 ) , organisational ( 2 ) , and exercise ( 1 ) . The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes . In trials that examined mortality and morbidity , significant benefits were reported for total mortality ( in 4 of 6 trials ; overall risk ratio ( RR ) 0.75 ( 95 % confidence intervals ( CI ) 0.65 , 0.87 ) ) , cardiovascular mortality ( 3 of 8 trials ; overall RR 0.63 ( 95 % CI 0.47 , 0.84 ) ) , and nonfatal cardiac events ( 5 of 9 trials ; overall RR 0.68 ( 95 % CI 0.55 , 0.84 ) ) . The heterogeneity between trials and generally poor quality of trials make any concrete conclusions difficult . However , the beneficial effects observed in this review are encouraging and should stimulate further research Background Lifestyle measures of coronary heart disease ( CHD ) prevention have been overshadowed by the efficacy of drug treatments . This is particularly the case in the setting of secondary prevention where the benefits of lipid lowering , anti-platelet and anti-hypertensive drugs have been emphasised in numerous trials . Lifestyle measures address several CHD risk factors at once and are generally free of serious side effects . Objectives The objective of the present study was to determine whether a comprehensive programme of lifestyle modification could favourably influence dietary and exercise habits in addition to smoking cessation over two years . In addition , an attempt was made to evaluate if this programme could favourably influence the five-year CHD-risk in the male population included in the study . Design A total of 197 patients with proven coronary heart disease were included and r and omised to a lifestyle intervention programme or to usual care . Follow-up was after a period of two years . Methods Intervention comprised a low fat diet , regular exercise , smoking cessation , psychosocial support and education , delivered by nurses on the rationale for pharmacological and lifestyle measures . Usual care comprised follow-up in the routine outpatient clinic . Both groups were given the same comprehensive medication according to recent guidelines . Results Patients in the lifestyle intervention group reduced the intake of saturated fat , sugar and cholesterol ( P<0.001 ) , increased their exercise level ( P<0.01 ) and stopped smoking ( P<0.05 ) when compared with the usual care group . A sub analysis of the influence of five-year CHD calculated risk in males result ed in a relative risk reduction of 22 % ( 95 % confidence intervals 9 - 35 ) . Although significant , this result must be interpreted with caution due to poor statistical power and reproducibility of the method . Conclusions In the presence of modern drug treatments for secondary cardiovascular disease prevention it remains possible through a favourable diet , exercise and smoking cessation to show an additional reduction in the five-year risk for CHD in males Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 Objectives : The aim of the study was twofold ; 1 ) to develop a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease ( CHD ) discharged from the University Hospital of North Norway , and 2 ) to explore the impact of the program with regards to adherence to a medication assessment tool for secondary prevention of CHD and change in biomedical risk factors . Methods : A total of 102 patients aged 18 - 82 years were enrolled in a non-blinded r and omized controlled trial with an intervention group and a control group . The intervention comprised medication reconciliation , medication review and patient education during three meetings ; at discharge , after three months and after twelve months . The control group received st and ard care from their general practitioner . Primary outcomes were adherence to clinical guideline recommendations concerning prescription , therapy goal achievement and lifestyle education  defined in the medication assessment tool for secondary prevention of CHD ( MAT-CHDSP ) . Secondary outcomes included changes in the biomedical risk factors cholesterol , blood pressure and blood glucose . Results : Ninety-four patients completed the trial , 48 intervention group patients and 46 controls . Appropriate prescribing was high , but therapy goal achievement was low in both groups . Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end , 78.4 % vs. 62.0 % , p<0.001 . The difference was statistically significant for the documented lifestyle advices in intervention group patients . No significant improvements in biomedical risk factors were observed in favor of the intervention group . Conclusions : The study showed an increased guideline adherence in both study groups . This indicates that attention to clinical practice guideline recommendations in itself increases adherence – which may be a clinical pharmacist task . A larger adequately powered study is needed to show a significant difference in biomedical risk factor improvements in favor of the intervention . Amendments to the follow-up program are suggested before implementation in st and ard patient care can be recommended Disseminating and implementing evidence -based , cardiovascular disease ( CVD ) prevention lifestyle interventions in community setting s and in ethnic minority population s is a challenge . We describe the design and methods for the South Asian Heart Lifestyle Intervention ( SAHELI ) study , a pilot study design ed to determine the feasibility and initial efficacy of a culturally-targeted , community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians ( SAs ) . Participants with at least one CVD risk factor will be r and omized to either a lifestyle intervention or a control group .  Participants in both groups will be screened in a community setting and receive a primary care referral after r and omization . Intervention participants will receive 6weeks of group classes , followed by 12weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal . Control participants will receive their screening results and monthly mailings on CVD prevention . Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline , 3- , and 6-month follow-up . Secondary outcomes will be changes in weight , clinical risk factors , primary care visits , self-efficacy , and social support . This study will be one of the first to pilot-test a lifestyle intervention for SAs , one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk . Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population Objectives : To evaluate the effects of nurse-led secondary prevention clinics for coronary heart disease ( CHD ) in primary care on total mortality and coronary event rates after 10 years . Design : Follow-up of a r and omised controlled trial by review of national data sets . Setting : Stratified r and om sample of 19 general practice s in northeast Scotl and . Participants : Original study cohort of 1343 patients , aged < 80 years , with a working diagnosis of CHD , but without dementia or terminal illness and not housebound . Intervention : Nurse-led secondary prevention clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow-up for 1 year , Main outcome measures : Total mortality and coronary events ( non-fatal myocardial infa rct ions ( MIs ) and coronary deaths ) . Results : Mean ( SD ) follow-up was at 10.2 ( 0.19 ) years . No significant differences in total mortality or coronary events were found at 10 years . 254 patients in the intervention group and 277 patients in the control group had died : cumulative death rates were 38 % and 41 % , respectively ( p = 0.177 ) . 196 coronary events occurred in the intervention group and 195 in the control group : cumulative event rates were 29.1 % and 29.1 % , respectively ( p = 0.994 ) . When Kaplan – Meier survival analysis , adjusted for age , sex and general practice , was used , proportional hazard ratios were 0.88 ( 0.74 to 1.04 ) for total mortality and 0.96 ( 0.79 to 1.18 ) for coronary death or non-fatal MI . No significant differences in the distribution of cause of death classifications was found at either 4 or 10 years . Conclusions : After 10 years , differences between groups were no longer significant . Total mortality survival curves for the intervention and control groups had not converged , but the coronary event survival curves had . Possibly , therefore , the earlier that secondary prevention is optimised , the less likely a subsequent coronary event is to prove fatal Background The aim of the SPHERE study is to design , implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease ( CHD ) in general practice across two different health systems on the isl and of Irel and .CHD is a common cause of death and a significant cause of morbidity in Irel and . Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives . Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the isl and of Irel and . The review literature recommends structured programmes with continued support and follow-up of patients ; the provision of training , tailored to practice needs of access to evidence of effectiveness of secondary prevention ; structured recall programmes that also take account of individual practice needs ; and patient-centred consultations accompanied by attention to disease management guidelines . Methods SPHERE is a cluster r and omised controlled trial , with practice -level r and omisation to intervention and control groups , recruiting 960 patients from 48 practice s in three study centres ( Belfast , Dublin and Galway ) . Primary outcomes are blood pressure , total cholesterol , physical and mental health status ( SF-12 ) and hospital re-admissions . The intervention takes place over two years and data is collected at baseline , one-year and two-year follow-up . Data is obtained from medical charts , consultations with practitioners , and patient postal question naires . The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice . It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients . General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD . Patients are invited to attend regular four-monthly consultations over two years , during which targets and goals for secondary prevention are set and review ed . The analysis will be strengthened by economic , policy and qualitative components This paper describes a r and omized study to evaluate the effects of a comprehensive lifestyle management intervention for 279 postmenopausal women with type 2 diabetes who are at elevated risk for coronary heart disease ( CHD ) . The intervention , called the Mediterranean Lifestyle Trial , is focused on dietary factors , physical activity , social support and stress management . The Mediterranean Lifestyle Trial relies on a synthesis of Social Cognitive Theory and Social Ecologic Theory , as well as goal -systems theory , to explicitly inform the lifestyle intervention and to address maintenance . Thus , the trial should help illuminate the theoretical mechanisms responsible for lifestyle change . Primary outcome variables are dietary , stress management and physical activity behavior change , quality of life , and CHD-related biological risk factors . Hypothesized mediating variables include self-efficacy , coping , and social and environmental support . Following the initial 6-month intervention , participants in the intervention condition are r and omized to one of two groups design ed to enhance maintenance of effects : either a peer-led support group or a personalized multilevel community re sources maintenance condition . Unlike the peer group , the personalized approach focuses on multiple levels of community re sources to promote healthful lifestyle change . Because this research focuses on issues of generalization and translation to practice , the RE- AIM evaluation framework is being used to evaluate Reach , Effectiveness , Adoption , Implementation and Maintenance . This framework will help to translate research into practice by directing research ers ' attention to important but seldom-investigated strategies for enhancing longer-term maintenance . Specifically , the study tests how long-term maintenance may be improved through the use of existing community re sources , an intervention based on multiple environmental factors and multiple lifestyle behaviors , and lay leaders versus personalized professional support Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Abstract Background Coronary heart disease ( CHD ) is the most prevalent type of cardiac disease among adults worldwide , including those in Singapore . Most of its risk factors , such as smoking , physical inactivity and high blood pressure , are preventable . mHealth has improved in the last decade , showing promising results in chronic disease prevention and health promotion worldwide . Our aim was to develop and examine the effect of a 4-week Smartphone-Based Coronary Heart Disease Prevention ( SBCHDP ) programme in improving awareness and knowledge of CHD , perceived stress as well as cardiac-related lifestyle behaviours in the working population of Singapore . Methods The smartphone app “ Care4Heart ” was developed as the main component of the programme . App content was review ed and vali date d by a panel of experts , including two cardiologists and two experienced cardiology-trained nurses . A pilot r and omised controlled trial was conducted . Eighty working people were recruited and r and omised to either the intervention group ( n = 40 ) or the control group ( n = 40 ) . The intervention group underwent a 4-week SBCHDP programme , whereas the control group were offered health promotion websites only . The participants ’ CHD knowledge , perceived stress and behavioural risk factors were measured at baseline and on the 4th week using the Heart Disease Fact Question naire-2 , Perceived Stress Scale , and Behavioural Risk Factor Surveillance System . Results After the SBCHDP programme , participants in the intervention group had a better awareness of CHD being the second leading cause of death in Singapore ( X2 = 6.486 , p = 0.039 ) , a better overall CHD knowledge level ( t = 3.171 , p = 0.002 ) , and better behaviour concerning blood cholesterol control ( X2 = 4.54 , p = 0.033 ) than participants in the control group . Conclusion This pilot study partially confirmed the positive effects of the SBCHDP programme in improving awareness and knowledge of CHD among the working population . Due to the small sample size and short follow-up period , this study was underpowered to detect significant differences between groups . A full-scale longitudinal study is required in the future to confirm the effectiveness of the SBCHDP programme UNLABELLED Patients with coronary artery disease ( CAD ) are at high risk of recurrent events . A healthy lifestyle can significantly reduce this risk . A previous trial , R and omized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists ( RESPONSE ) , demonstrated that nurse-coordinated outpatient clinics improve drug treatment of cardiovascular risk factors . However , lifestyle-related risk factors , including smoking , overweight , and physical inactivity , were common and remained largely unchanged at follow-up in most patients ( 66 % ) . The aim of the current study is to evaluate the impact of 3 community-based lifestyle programs in patients after hospitalization for CAD . We are conducting a multicenter ( n = 15 ) , r and omized trial that will recruit 800 patients to test the efficacy of up to 3 widely available commercial lifestyle programs , aim ed at patients and their partners , on top of usual care . These programs are aim ed at smoking cessation ( Luchtsignaal ( ® ) ) , weight loss ( Weight Watchers ( ® ) ) , and improving physical activity ( Philips DirectLife ( ® ) ) . OUTCOMES The primary outcome at 12months is the proportion of patients in whom at least 1 lifestyle risk factor is improved without deterioration in any of the other 2 , and a relative increase of at least 30 % in this proportion is considered clinical ly relevant Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events .  Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary Background Mobile technology has the potential to deliver behavior change interventions ( mHealth ) to reduce coronary heart disease ( CHD ) at modest cost . Previous studies have focused on single behaviors ; however , cardiac rehabilitation ( CR ) , a component of CHD self-management , needs to address multiple risk factors . Objective The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program ( Text4Heart ) to improve adherence to recommended lifestyle behaviors ( smoking cessation , physical activity , healthy diet , and nonharmful alcohol use ) in addition to usual care ( traditional CR ) . Methods A 2-arm , parallel , r and omized controlled trial was conducted in New Zeal and adults diagnosed with CHD . Participants were recruited in-hospital and were encouraged to attend center-based CR ( usual care control ) . In addition , the intervention group received a personalized 24-week mHealth program , framed in social cognitive theory , sent by fully automated daily short message service ( SMS ) text messages and a supporting website . The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score ( ≥3 ) at 3 and 6 months . Secondary outcomes included clinical outcomes , medication adherence score , self-efficacy , illness perceptions , and anxiety and /or depression at 6 months . Baseline and 6-month follow-up assessment s ( unblinded ) were conducted in person . Results Eligible patients ( N=123 ) recruited from 2 large metropolitan hospitals were r and omized to the intervention ( n=61 ) or the control ( n=62 ) group . Participants were predominantly male ( 100/123 , 81.3 % ) , New Zeal and European ( 73/123 , 59.3 % ) , with a mean age of 59.5 ( SD 11.1 ) years . A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months ( AOR 2.55 , 95 % CI 1.12 - 5.84 ; P=.03 ) , but not at 6 months ( AOR 1.93 , 95 % CI 0.83 - 4.53 ; P=.13 ) . The intervention group reported significantly greater medication adherence score ( mean difference : 0.58 , 95 % CI 0.19 - 0.97 ; P=.004 ) . The majority of intervention participants reported reading all their text messages ( 52/61 , 85 % ) . The number of visits to the website per person ranged from zero to 100 ( median 3 ) over the 6-month intervention period . Conclusions A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zeal and adults with CHD compared to usual care alone . The effect was not sustained to the end of the 6-month intervention . A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events . Trial Registration ACTRN 12613000901707 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=364758&is Review = true ( Archived by WebCite at http://www.webcitation.org/6c4qhcHKt OBJECTIVES To estimate the impact of small reductions in the population distribution of diastolic blood pressure ( DBP ) , such as those potentially achievable by population -wide lifestyle modification , on incidence of coronary heart disease ( CHD ) and stroke . DESIGN Published data from the Framingham Heart Study , a longitudinal cohort study , and from the National Health and Nutrition Examination Survey II , a national population survey , were used to examine the impact of a population -wide strategy aim ed at reducing DBP by an average of 2 mm Hg in a population including normotensive subjects . SETTING / PARTICIPANTS White men and women aged 35 to 64 years in the United States . MAIN OUTCOME MEASURES Incidence of CHD and stroke , including transient ischemic attacks ( TIAs ) . RESULTS Data from overviews of observational studies and r and omized trials suggest that a 2-mm Hg reduction in DBP would result in a 17 % decrease in the prevalence of hypertension as well as a 6 % reduction in the risk of CHD and a 15 % reduction in risk of stroke and TIAs . From an application of these results to US white men and women aged 35 to 64 years , it is estimated that a successful population intervention alone could reduce CHD incidence more than could medical treatment for all those with a DBP of 95 mm Hg or higher . It could prevent 84 % of the number prevented by medical treatment for all those with a DBP of 90 mm Hg or higher . For stroke ( including TIAs ) , a population -wide 2-mm Hg reduction could prevent 93 % of events prevented by medical treatment for those with a DBP of 95 mm Hg or higher and 69 % of events for treatment for those with a DBP of 90 mm Hg or higher . A combination strategy of both a population reduction in DBP and targeted medical intervention is most effective and could double or triple the impact of medical treatment alone . Adding a population -based intervention to existing levels of hypertension treatment could prevent an estimated additional 67,000 CHD events ( 6 % ) and 34,000 stroke and TIA events ( 13 % ) annually among all those aged 35 to 64 years in the United States . CONCLUSIONS A small reduction of 2 mm Hg in DBP in the mean of the population distribution , in addition to medical treatment , could have a great public health impact on the number of CHD and stroke events prevented . Whether such DBP reductions can be achieved in the population through lifestyle interventions , in particular through sodium reduction , depends on the results of ongoing primary prevention trials as well as the cooperation of the food industry , government agencies , and health education professionals 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 CONTEXT Elderly persons and women were underrepresented in r and omized controlled trials ( RCTs ) prior to 1990 . Since then , efforts have been made to correct these biases , but their effect is unclear . OBJECTIVE To determine whether the percentage of elderly persons and women in published clinical trials of acute coronary syndromes has increased and how this enrollment compared with disease prevalence . DATA SOURCES The MEDLINE and Cochrane data bases were search ed for English- language articles from January 1966 to March 2000 regarding myocardial infa rct ion , unstable angina , or acute coronary syndromes . Additional data sources included meta-analyses , review articles , and cardiology textbooks . Estimates of community-based myocardial infa rct ion rates came from the National Registry of Myocardial Infa rct ion and the Worcester Heart Study . STUDY SELECTION Published RCTs of acute coronary syndrome patients were included and trials enrolling 50 patients or fewer , those without clinical end points , papers published in a language other than English , and unpublished manuscripts were excluded . Of 7645 studies identified , 593 RCTs were selected for review . DATA EXTRACTION The RCTs were abstract ed by 2 of the authors for year of publication , source of support ( ie , funding ) , pharmacotherapy , study phase , number of study sites , trial location , number of patients , mean age of the study population , and any age exclusion criteria for enrollment . DATA SYNTHESIS The number of published RCTs with explicit age exclusions has declined from 58 % during 1966 - 1990 to 40 % during 1991 - 2000 . Trial enrollment of patients aged 75 years or older increased from 2 % for studies published during 1966 - 1990 to 9 % during 1991 - 2000 , but remains well below their representation among all patients with myocardial infa rct ion ( 37 % ) in the United States . Enrollment of women has risen from 20 % for studies published between 1966 - 1990 to 25 % during 1991 - 2000 , but remains well below their proportion of all patients with myocardial infa rct ion ( 43 % ) in the United States . CONCLUSIONS Attempts at making cardiovascular RCTs more inclusive appear to have had limited success ; thus , women and elderly persons remain underrepresented in published trial literature relative to their disease prevalence . Because safety and efficacy can vary as a function of sex and age , these enrollment biases undermine efforts to provide evidence -based care to all cardiac patients Background : The Mediterranean Lifestyle Program was evaluated for its effects on multiple behavioral risk factors for coronary heart disease ( CHD )  among postmenopausal women with diabetes . Purpose : Our purpose is to test a comprehensive lifestyle management intervention to reduce CHD risk in postmenopausal women with type 2 diabetes . Methods : Participants ( N = 279 ) were r and omized to usual care ( UC ) or Mediterranean Lifestyle Program , a lifestyle change intervention aim ed at the behavioral risk factors ( eating patterns , physical activity , stress management , and social support ) affecting risk for CHD in postmenopausal women with type 2 diabetes . Results : In original and intent-to-treat analyses ,  Mediterranean Lifestyle Program participants showed significantly greater improvement in dietary behaviors , physical activity , stress management , perceived support , and weight loss at 6 months compared to UC . Conclusions : This study demonstrated the effectiveness of the Mediterranean Lifestyle Program in improving self-care among women with type 2 diabetes , showed that postmenopausal women could make comprehensive lifestyle changes , and provided evidence that a program using social-cognitive strategies and peer support can be used to modify multiple lifestyle behaviors Background Many patients with type 2 diabetes fail to achieve good glycaemic control . Poor control is associated with complications including coronary heart disease ( CHD ) . Effective self-management and engagement in health behaviours can reduce risks of complications . However , patients often struggle to adopt and maintain these behaviours . Self-management interventions have been found to be effective in improving glycaemic control . Recent developments in the field of genetics mean that patients can be given personalised information about genetic- and lifestyle-associated risk of developing CHD . Such information may increase patients ’ motivation to engage in self-management . The Coronary Risk in Diabetes ( CoRDia ) trial will compare the effectiveness of a self-management intervention , with and without provision of personalised genetic- and lifestyle-associated risk information , with usual care , on clinical and behavioural outcomes , the cognitive predictors of behaviour , and psychological wellbeing . Methods / Design Participants will be adults aged 25–74 years registered with general practice s in the East of Engl and , diagnosed with type 2 diabetes , with no history of heart disease , and with a glycated haemoglobin level of ≥6.45 % ( 47 mmol/mol ) . Consenting participants will be r and omised to one of three arms : usual care control , group self-management only , group self-management plus personalised genetic- and lifestyle-associated risk information . The self-management groups will receive four weekly 2-hour group sessions , focusing on knowledge and information sharing , problem solving , goal setting and action planning to promote medication adherence , healthy eating , and physical activity . Primary outcomes are glycaemic control and CHD risk . Clinical data will be collected from GP records , including HbA1c , weight , body mass index , blood pressure , and HDL and total cholesterol . Self-reported health behaviours , including medication adherence , healthy eating and physical activity , and cognitive outcomes will be assessed by question naire . Measures will be taken at baseline , 3 months ( question naire only ) , 6 months and 12 months post-baseline . Discussion This study will determine whether the addition of personalised genetic- and lifestyle-associated CHD risk information to a group self-management intervention  improves diabetes control and CHD risk compared with group self-management and usual care . Effectiveness of the combined intervention on health behaviours cognitions theorised to predict them , and psychological outcomes will also be investigated . Trial registration This study has been registered at Clinical Trials.gov ; registration identifier NCT01891786 , registered 28 June 2013 IMPORTANCE Most primary care clinicians lack the skills and re sources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk . Thus , effective and feasible CHD prevention programs are needed for typical practice setting s. OBJECTIVE To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats . DESIGN , SETTING , AND PARTICIPANTS A comparative effectiveness trial in 5 diverse family medicine practice s in North Carolina . Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , ≥10 % ) . INTERVENTIONS Participants were r and omized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions . After r and omization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies . Participants chose the risk-reducing strategies they wished to follow . MAIN OUTCOMES AND MEASURES The primary outcome was within-group change in FRS at 4-month follow-up . Other measures included st and ardized assessment s of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence . Acceptability and cost-effectiveness were also assessed . Outcomes were assessed at 4 and 12 months . RESULTS Of 2274 screened patients , 385 were r and omized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % . Follow-up at 4 and 12 months included 91 % and 87 % of the r and omized participants , respectively . There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) . At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) . The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor- and web-based interventions , respectively . CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up . The web format was less expensive . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01245686 IMPORTANCE Cardiovascular disease prevention , including lifestyle modification , is important but underutilized . Mobile health strategies could address this gap but lack evidence of therapeutic benefit . OBJECTIVE To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors . DESIGN AND SETTING The Tobacco , Exercise and Diet Messages ( TEXT ME ) trial was a parallel-group , single-blind , r and omized clinical trial that recruited 710 patients ( mean age , 58 [ SD , 9.2 ] years ; 82 % men ; 53 % current smokers ) with proven coronary heart disease ( prior myocardial infa rct ion or proven angiographically ) between September 2011 and November 2013 from a large tertiary hospital in Sydney , Australia . INTERVENTIONS Patients in the intervention group ( n = 352 ) received 4 text messages per week for 6 months in addition to usual care . Text messages provided advice , motivational reminders , and support to change lifestyle behaviors . Patients in the control group ( n=358 ) received usual care . Messages for each participant were selected from a bank of messages according to baseline characteristics ( eg , smoking ) and delivered via an automated computerized message management system . The program was not interactive . MAIN OUTCOMES AND MEASURES The primary end point was low-density lipoprotein cholesterol ( LDL-C ) level at 6 months . Secondary end points included systolic blood pressure , body mass index ( BMI ) , physical activity , and smoking status . RESULTS At 6 months , levels of LDL-C were significantly lower in intervention participants , with concurrent reductions in systolic blood pressure and BMI , significant increases in physical activity , and a significant reduction in smoking . The majority reported the text messages to be useful ( 91 % ) , easy to underst and ( 97 % ) , and appropriate in frequency ( 86 % ) . [ table : see text ] . CONCLUSIONS AND RELEVANCE Among patients with coronary heart disease , the use of a lifestyle-focused text messaging service compared with usual care result ed in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors . The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12611000161921 Diabetes and coronary heart disease ( CHD ) are two of the most prevalent medical illnesses in the US population and comorbid depression occurs in up to 20 % of these patients . Guidelines for management of diabetes and CHD overlap for healthy lifestyle and disease-control recommendations . However , the majority of patients with these medical illnesses have been shown to have inadequate control of key risk factors such as blood pressure , LDL cholesterol , or blood sugar . Comorbid depression has been shown to adversely affect self-care of diabetes and CHD , and is associated with an increased risk of complications and mortality . Interventions that have improved quality and outcomes of depression care alone in patients with diabetes and CHD have not demonstrated benefits in self-care , improved disease control or morbidity and mortality . This paper describes the design and development of a new biopsychosocial intervention ( TEAMcare ) aim ed at improving both medical disease control and depression in patients with poor control of diabetes and /or CHD who met the criteria for comorbid depression . A team approach is used with a nurse interventionist who receives weekly psychiatric and primary care physician caseload supervision in order to enhance treatment by the primary care physician . This intervention is being tested in an NIMH-funded r and omized controlled trial in a large integrated health plan BACKGROUND Although lifestyle and medications are effective for coronary heart disease ( CHD ) risk reduction , few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction . In this paper , we report on the design and baseline characteristics of participants for just such a trial . METHODS We conducted a r and omized trial of the same lifestyle and medication intervention delivered in two alternate formats : counselor-delivered or web-based . The trial was conducted at 5 diverse practice s in a family medicine research network and included men and women age 35 - 79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10 % or a known history of cardiovascular disease . After individual-level r and omization , participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months . The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease . Secondary outcomes , measured among all participants , included changes in CHD risk factors , cost-effectiveness , and acceptability at 4 and 12-month follow-up . RESULTS We r and omized 489 eligible patients : 389 without and 100 with a known history of cardiovascular disease . Mean age was 62.3 . 75 % were white , 25 % African-American . 45 % had a college education . 88 % had health insurance . Mean 10-year predicted CHD risk was 16.9 % . CONCLUSION We have successfully recruited a diverse sample of practice s and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention BACKGROUND Among patients with coronary artery disease ( CAD ) , improvement of lifestyle-related risk factors ( LRFs ) reduces cardiovascular morbidity and mortality . However , modification of LRFs is highly challenging . OBJECTIVES This study sought to evaluate the impact of combining community-based lifestyle programs with regular hospital-based secondary prevention . METHODS The authors performed a r and omized controlled trial of nurse-coordinated referral of patients and their partners to 3 widely available community-based lifestyle programs , in 15 hospitals in the Netherl and s. Patients admitted for acute coronary syndrome and /or revascularization , with ≥1 LRF ( body mass index > 27 kg/m2 , self-reported physical inactivity , and /or smoking ) were included . All patients received guideline -based usual care . The intervention was based on 3 lifestyle programs for weight reduction , increasing physical activity , and smoking cessation . The primary outcome was the proportion of success at 12 months , defined as improvement in ≥1 qualifying LRF using weight ( ≥5 % reduction ) , 6-min-walking distance ( ≥10 % improvement ) , and urinary cotinine ( 200 ng/ml detection limit ) without deterioration in the other 2 . RESULTS The authors r and omized 824 patients . Complete data on the primary outcome were available in 711 patients .  The proportion of successful patients in the intervention group was 37 % ( 133 of 360 ) compared with 26 % ( 91 of 351 ) in the control group ( p = 0.002 ; risk ratio : 1.43 ; 95 % confidence interval : 1.14 to 1.78 ) . In the intervention group , partner participation was associated with a significantly greater success rate ( 46 % vs. 34 % ; p = 0.03 ) . CONCLUSIONS Among patients with coronary artery disease , nurse-coordinated referral to a comprehensive set of community-based , widely available lifestyle interventions , with optional partner participation , leads to significant improvements in LRFs . ( RESPONSE-2 : R and omised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 ; NTR3937 )
The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes .
The effectiveness of lifestyle interventions within secondary prevention of coronary heart disease ( CHD ) remains unclear .
This systematic review aim ed to determine their effectiveness and included r and omized controlled trials of lifestyle interventions , in primary care or community setting s , with a minimum follow-up of three months , published since 1990 .