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 The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial 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 Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme A randomized controlled trial of a cognitive behavioural patient education intervention vs a traditional information leaflet to address the cardiovascular aspects of rheumatoid disease. Development of a set of mobile phone text messages designed for prevention of recurrent cardiovascular events The impact of individualised cardiovascular disease (CVD) risk estimates and lifestyle advice on physical activity in individuals at high risk of CVD: a pilot 2 × 2 factorial understanding risk trial Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial A randomised controlled trial of providing personalised cardiovascular risk information to modify health behaviour School-based Interventions Improve Heart Health in Children With Multiple Cardiovascular Disease Risk Factors Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang National Study of Physician Awareness and Adherence to Cardiovascular Disease Prevention Guidelines The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Impact of socioeconomic deprivation on screening for cardiovascular disease risk in a primary prevention population: a cross-sectional study Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study Isfahan Healthy Heart Programme: a comprehensive integrated community-based programme for cardiovascular disease prevention and control. Design, methods and initial experience Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial.
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 BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for over one third of the mortality difference between African Americans and white patients . The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors . OBJECTIVES The current study is aim ed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin , and low-density lipoprotein cholesterol . METHODS A sample of African American patients with diabetes ( N = 400 ) will receive written education material at baseline and be r and omized to one of 2 arms : ( 1 ) usual primary care or ( 2 ) nurse-administered disease-management intervention combining patient self-management support and provider medication management . The nurse administered intervention is delivered monthly over the telephone . The nurses also interacts with the primary care providers at 3 , 6 , and 9 months to provide concise patient up date s and facilitate changes in medical management . All patients are followed for 12 months after enrollment . The primary outcomes are change in glycosylated hemoglobin , systolic blood pressure , and low-density lipoprotein cholesterol over 12-months . Secondary outcomes include change in overall cardiovascular risk , aspirin use , and health behaviors . CONCLUSION Given the continued racial disparities in CVD , the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients BACKGROUND Psychosocial factors are independently associated with increased risk of cardiovascular disease ( CVD ) morbidity and mortality , but the effects of psychosocial factor intervention on CVD are uncertain . We performed a r and omized controlled clinical trial of cognitive behavioral therapy ( CBT ) to measure its effects on CVD recurrence . METHODS The study included 362 women and men 75 years or younger who were discharged from the hospital after a coronary heart disease event within the past 12 months . Patients were r and omized to receive traditional care  ( reference group , 170 patients ) or traditional care plus a CBT program ( intervention group , 192 patients ) , focused on stress management , with 20 two-hour sessions during 1 year . Median attendance at each CBT session was 85 % . Outcome variables were all-cause mortality , hospital admission for recurrent CVD , and recurrent acute myocardial infa rct ion . RESULTS During a mean 94 months of follow-up , the intervention group had a 41 % lower rate of fatal and nonfatal first recurrent CVD events ( hazard ratio [ 95 % confidence interval ] , 0.59 [ 0.42 - 0.83 ] ; P = .002 ) , 45 % fewer recurrent acute myocardial infa rct ions ( 0.55 [ 0.36 - 0.85 ] ; P = .007 ) , and a nonsignificant 28 % lower all-cause mortality ( 0.72 [ 0.40 - 1.30 ] ; P = .28 ) than the reference group after adjustment for other outcome -affecting variables . In the CBT group there was a strong dose-response effect between intervention group attendance and outcome . During the first 2 years of follow-up , there were no significant group differences in traditional risk factors . CONCLUSIONS A CBT intervention program decreases the risk of recurrent CVD and recurrent acute myocardial infa rct ion . This may have implication s for secondary preventive programs in patients with coronary heart disease . Trial Registration clinical trials.gov Identifier : NCT00888485 Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register 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 Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been " identified"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India Background Because of a high cardiovascular disease ( CVD ) risk in people with Familial Hypercholesterolemia ( FH ) , early prevention of cardiovascular disease is important for health gain and cost reduction . This project focuses on the development and evaluation of an innovative intervention aim ing to reduce CVD risk by promoting a healthy lifestyle among people with FH . Methods This project is design ed as a r and omised controlled trial in which individuals with FH will be assigned r and omly to a control or intervention group . In the intervention group ( n = 200 ) , participants will receive a personalized intervention which is a combination of web-based tailored lifestyle advice and personal counselling by a lifestyle coach .  The control group ( n = 200 ) will receive care as usual . Primary outcomes are biological indicators of CVD risk : systolic blood pressure , glucose , BMI , waist circumference and lipids ( triglycerides , total , LDL and HDL cholesterol ) . Secondary outcomes are : healthy lifestyle behaviour ( with regard to smoking , physical activity , dietary pattern and compliance to statin therapy ) and psychological correlates and determinants of healthy lifestyle behaviour ( knowledge , attitude , risk perception , social influence , self-efficacy , cues to action , intention and autonomy ) . Measurement will take place at baseline , and at 3 and 12 months after r and omisation . Additionally , a throughout process-evaluation will be conducted to assess and monitor intervention implementation during the trial . Discussion Results of the PRO-FIT project will provide information about the effects and implementation of a healthy lifestyle intervention for individuals with FH . Our experiences with this intervention will be indicative about the suitability , feasibility and benefits of this approach for future interventions in other high-risk groups , such as Familial Combined Hypercholesterolemia ( FCH ) and diabetes . Trial registration Background Cardiovascular diseases ( CVD ) are the leading cause of death and the third cause of disability in Europe . Prevention programmes should include interventions aim ed at a reduction of medical risk factors ( hypertension , hypercholesterol , hyperglycemia , overweight and obesity ) as well as behavioural risk factors ( sedentary lifestyle , high fat intake and low fruit and vegetable intake , smoking ) . The aim of this study is to investigate the effects of a multifaceted , multidisciplinary electronic prevention programme on cardiovascular risk factors . Methods / Design In a r and omized controlled trial , one group will receive a maximal intervention  (= intervention group ) . The intervention group will be compared to the control group receiving a minimal intervention .  An inclusion of 350 patients in total , with a follow-up of 3 years is foreseen . The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas , insuring for guaranteed income in case of illness for self-employed . The maximal intervention group receives several prevention consultations by their general practitioner ( GP ) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors . These patients receive a follow-up with intensive support of health behaviour change via different methods , i.e. a tailored website and personal advice of a multidisciplinary team ( psychologist , physiotherapist and dietician ) . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines . The primary outcome measures will be cardiovascular risk factors . The secondary outcome measures are cardiovascular events , quality of life , costs and incremental cost effectiveness ratios . The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback . Discussion This trial incorporates interventions by GPs and other health professionals aim ing at a reduction of medical and behavioural cardiovascular risk factors . An assessment of clinical , psychological and economical outcome measures will be performed . Trial registration IS RCT OBJECTIVES Cardiovascular disease ( CVD ) is responsible for 50 % of the excess mortality for patients with RA . This study aim ed to evaluate a novel 8-week cognitive behavioural patient education intervention design ed to effect behavioural change with regard to modifiable CVD risk factors in people with RA . METHODS This was a non-blinded r and omized controlled trial with a delayed intervention arm . Participants were r and omly assigned to receive the cognitive behavioural education intervention or a control information leaflet at a ratio of 1:1 . The primary outcome measure was patient 's knowledge of CVD in RA ; secondary measures were psychological measures relating to effecting behaviour change , actual behaviour changes and clinical risk factors . Data were collected at baseline , 2 and 6 months . RESULTS A total of 110 participants consented ( 52 in the intervention group and 58 in the control group ) to participate in the study . At 6 months , those in the intervention group had significantly higher knowledge scores ( P < 0.001 ) ; improved behavioural intentions to increase exercise ( P < 0.001 ) , eat a low-fat diet ( P = 0.01 ) and lose weight ( P = 0.06 ) ; and lower mean diastolic blood pressure by 3.7 mmHg , whereas the control group 's mean diastolic blood pressure increased by 0.8 mmHg . There was no difference between the groups on actual behaviours . CONCLUSIONS Patient education has a significant role to play in CVD risk factor modification for patients with RA , and the detailed development of this programme probably contributed to its successful results . It is disappointing that behaviours , as we measured them , did not change . The challenge , as always , is how to translate behavioural intentions into action . Larger studies , powered specifically to look at behavioural changes , are required . Trial registration . National Institute for Health Research , UKCRN 4566 Background : Supporting lifestyle change is an effective way of preventing recurrent events in people with cardiovascular disease ( CVD ) . However , there is a need to develop innovative strategies that increase access to programmes for individuals at high risk of CVD . This study aim ed to develop a bank of text messages design ed to provide advice , motivation , and support for decreasing cardiovascular risk . Design : Iterative development process with mixed methods Methods : An initial bank of 120 text messages was drafted based on behaviour change techniques , guidelines , and input from clinicians and public health experts . A question naire was then administered to participants ( n = 53 ) for evaluation of message content , usefulness , and language . To test the process of delivery , a pilot study was conducted using a specifically design ed computer programme that delivered messages to multiple mobile phones according to a pre-specified schedule . Data were collected regarding message timing , delivery , and usefulness . Results : In the qualitative question naire , 92 % of participants found the messages easy to underst and and 86 % found the messages contained useful information . Positive feedback was also obtained from the pilot study . Based on these results , together with suggestions provided , several messages were reworded and an additional 44 were written . The need for semi-personalization was also identified and a r and om set of 103 individualized messages was created . Conclusions : A final bank of 137 mobile telephone text messages design ed to support behaviour change and decrease cardiovascular risk have been developed through a multistep iterative process . This provides a scientific approach for future developers of health-related text messages Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care .  A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921 Objectives To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease ( CVD ) risk . Design A prospect i ve within-trial patient-level economic evaluation conducted alongside a r and omised controlled trial . Setting Patients recruited through primary care , and intervention delivered via telehealth service .  Participants Adults with a 10-year CVD risk ≥20 % , as measured by the QRISK2 algorithm , with at least 1 modifiable risk factor . Intervention A series of up to 13 scripted , theory-led telehealth encounters with healthcare advisors , who supported participants to make behaviour change , use online re sources , optimise medication and improve adherence . Participants in the control arm received  usual care . Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up , calculated from incremental cost and incremental quality -adjusted life years ( QALYs ) . Productivity impacts , participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework . Results 641 participants were r and omised—325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care . 18 % of participants had missing data on either costs , utilities or both . Multiple imputation was used for the base case results . The intervention was associated with incremental mean per-patient National Health Service ( NHS ) costs of £ 138 ( 95 % CI 66 to 211 ) and an incremental QALY gain of 0.012 ( 95 % CI −0.001 to 0.026 ) . The incremental cost-effectiveness ratio was £ 10 859 . Net monetary benefit at a cost-effectiveness threshold of £ 20 000 per QALY was £ 116 ( 95 % CI −58 to 291 ) , and the probability that the intervention was cost-effective at this threshold value was 0.77 . Similar results were obtained from a complete case analysis . Conclusions There is evidence to suggest that the Healthlines telehealth intervention was likely to be cost-effective at a threshold of £ 20 000 per QALY . Trial registration number IS RCT N27508731 ; Results . Prospect ively registered 05 July 2012 Background Decreasing salt consumption can prevent cardiovascular diseases ( CVD ) . Practically , it is difficult to promote people ’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health . Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases . Methods / Design This is a cluster r and omized trial . A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District , Chiang Rai province , Thail and , will be studied with informed consent . A health center recruiting 100 participants is a cluster , the unit of r and omization . Eight clusters will be r and omized into intervention and control arms and followed up for 1 year . Within the intervention clusters the following will be undertaken : ( 1 )  salt content in the daily diet will be measured and shown to study participants ; ( 2 )  24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants ; ( 3 ) a dietician will assist small group health education classes in cooking meals with less salt . The primary outcome is blood pressure change at the 1-year follow-up . Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake , incidence of CVD events and CVD death . The intention-to-treat analysis will be followed . Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up . Clinical CVD events and deaths will be analyzed by time-event analysis . Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally . Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model ( SEM ) . Multilevel regression analyses will be applied . Finally , the cost effectiveness of the intervention will be analyzed . Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system . Dietary salt reduction will be applied as a prioritized , community level intervention for the prevention of CVD in a developing country . Trial registration IS RCT We conducted a feasibility study of a web-based intervention , which provided personalized cardiovascular disease ( CVD ) risk information , behavioural risk reduction strategies and educational re sources . Participants were block-r and omized to the 3-month intervention ( n = 47 ) or to usual care ( n = 49 ) . Participants in the intervention group were presented with their CVD risk based on the Framingham risk score , and in three subsequent online encounters could select two behavioural/lifestyle modules , giving them an opportunity to complete six modules over the course of the study . Because it was self-guided , participants had differing levels of engagement with intervention material s. Most intervention group participants ( 77 % , n = 36 ) completed all modules . After 3 months there were no significant differences between the intervention and usual care groups for systolic blood pressure , body-mass index , CVD risk , smoking cessation or medication non-adherence . The study suggests that modest clinical improvements can be achieved by interventions that are entirely web-administered . However , web-based interventions do not replace the need for human interaction to communicate CVD risk and assist with decision-making Objective . To determine the immediate effects of two types of elementary school-based interventions on children with multiple cardiovascular disease ( CVD ) risk factors . Design . R and omized , controlled field trial . Setting . Conducted in 18 r and omly selected elementary schools across North Carolina . Study Participants . Four hundred twenty-two children age 9 ± 0.8 years with at least two risk factors at baseline : low aerobic power and either high serum cholesterol or obesity . Intervention . Both 8-week interventions consisted of a knowledge and attitude program and an adaptation of physical education . The classroom-based intervention was given by regular teachers to all children in the 3rd and 4th grade s. The risk-based intervention was given in small groups only to children with identified risk factors . Children in the control group received usual teaching and physical education . Outcome Measures . The primary outcome measure was cholesterol ; additional measures were blood pressure , body mass index , body fat , eating and activity habits , and health knowledge . Results . Both interventions produced large reductions in cholesterol ( −10.1 mg/dL and −11.7 mg/dL ) compared with a small drop ( −2.3 mg/dL ) in the controls . There was a trend for systolic blood pressure to increase less in both intervention groups than in the controls . Both intervention groups had a small reduction in body fat and higher health knowledge than the control group . Conclusions . Both brief interventions can improve the CVD risk profile of children with multiple risk factors . The classroom-based approach was easier to implement and used fewer re sources . This population approach should be considered as one means of early primary prevention of CVD Background Cardiovascular disease ( CVD ) is a major cause of death in China . Despite government efforts , the majority of hypertensive and diabetic patients in China do not receive proper treatment . Reducing CVD events requires long-term care that is proactive , patient-centred , community-based , and sustainable . We have design ed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals ( providers of primary care ) in rural Zhejiang , China . This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care , and whether the package is cost-effective and suitable for routine implementation and scale-up . Methods / Design This is a prospect i ve , open-label , cluster r and omized controlled trial ( RCT ) with blinded data analysis . The trial will r and omize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province . Participants will be identified from existing health records and will comprise adults aged 50 to 74 years , with a calculated 10-year CVD risk of 20 % or higher , or diabetes . In the intervention arm , participants will receive a package of interventions including : 1 ) healthy lifestyle counseling ( smoking cessation , and salt , oil , and alcohol reduction ) ; 2 ) prescription of a combination of drugs ( antihypertensives , aspirin , and statin ) ; and 3 ) adherence support for drug compliance and healthy lifestyle change . In the control arm , participants will receive usual care for hypertension and diabetes management at individual clinicians ’ discretion . The primary outcome is the incidence of severe CVD events over 24 months of follow-up . All CVD events will be defined according to the World Health Organization ( WHO ) monitoring of trends and determinants in cardiovascular disease ( MONICA ) definitions , diagnosed at the county hospital or higher level , and reported by the Zhejiang surveillance system . Secondary outcomes include : mean systolic and diastolic blood pressure , blood glucose , serum total cholesterol ( TC ) , and adherence to appointments , and drugs and lifestyle changes . Discussion This trial focuses on risk reduction of CVD rather than specific diseases . It is not design ed to compare therapeutic and healthy lifestyle interventions , but rather their combined effects in primary care setting s. Through the trial , we intend to underst and the effectiveness of the comprehensive CVD reduction package in routine practice . We also intend to underst and the barriers and facilitators to implementing the package , and thus to advise on policy and practice change . Trial registration Current Controlled Trials : IS RCT Background —Few data have evaluated physician adherence to cardiovascular disease ( CVD ) prevention guidelines according to physician specialty or patient characteristics , particularly gender . Methods and Results —An online study of 500 r and omly selected physicians ( 300 primary care physicians , 100 obstetricians/gynecologists , and 100 cardiologists ) used a st and ardized question naire to assess awareness of , adoption of , and barriers to national CVD prevention guidelines by specialty . An experimental case study design tested physician accuracy and determinants of CVD risk level assignment and application of guidelines among high- , intermediate- , or low-risk patients . Intermediate-risk women , as assessed by the Framingham risk score , were significantly more likely to be assigned to a lower-risk category by primary care physicians than men with identical risk profiles ( P<0.0001 ) , and trends were similar for obstetricians/gynecologists and cardiologists . Assignment of risk level significantly predicted recommendations for lifestyle  and preventive pharmacotherapy . After adjustment for risk assignment , the impact of patient gender on preventive care was not significant except for less aspirin ( P<0.01 ) and more weight management recommended ( P<0.04 ) for intermediate-risk women . Physicians did not rate themselves as very effective in their ability to help patients prevent CVD . Fewer than 1 in 5 physicians knew that more women than men die each year from CVD . Conclusions —Perception of risk was the primary factor associated with CVD preventive recommendations . Gender disparities in recommendations for preventive therapy were explained largely by the lower perceived risk despite similar calculated risk for women versus men . Educational interventions for physicians are needed to improve the quality of CVD preventive care and lower morbidity and mortality from CVD for men and women 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 Investigate the association between socioeconomic deprivation and completeness of cardiovascular disease ( CVD ) risk factor recording in primary care , uptake of screening in people with incomplete risk factor recording and with actual CVD risk within the screened subgroup . Design Cross-sectional study . Setting Nine UK general practice s. Participants 7987 people aged 50–74 years with no CVD diagnosis . Methods CVD risk was estimated using the Framingham equation from data extracted from primary care electronic health records . Where there was insufficient information to calculate risk , patients were invited to attend a screening assessment . Analysis Proportion of patients for whom clinical data were sufficiently complete to enable CVD risk to be calculated ; proportion of patients invited to screening who attended ; proportion of patients who attended screening whose 10-year risk of a cardiovascular event was high ( > 20 % ) . For each outcome , a set of logistic regression models were run . Crude and adjusted ORs were estimated for person-level deprivation , age , gender and smoking status . We included practice -level deprivation as a continuous variable and practice as a r and om effect to account for clustering . Results People who had lower  Indices of Multiple Deprivation ( IMD ) scores ( less deprived ) had significantly worse routine CVD risk factor recording ( adjusted OR 0.97 ( 0.95 to 1.00 ) per IMD decile ; p=0.042 ) . Screening attendance was poorer in those with more deprivation ( adjusted OR 0.89 ( 0.86 to 0.91 ) per IMD decile ; p<0.001 ) . Among those who attended screening , the most deprived were more likely to have CVD risk > 20 % ( OR 1.09 ( 1.03 to 1.15 ) per IMD decile ; p=0.004 ) . Conclusions Our data suggest that those who had the most to gain from screening were least likely to attend , potentially exacerbating existing health inequalities . Future research should focus on tailoring the delivery of CVD screening to ensure engagement of socioeconomically deprived groups Background Of all workers in Dutch construction industry , 20 % has an elevated risk of cardiovascular disease ( CVD ) . A major risk factor for CVD risk is an unhealthy lifestyle . The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk , and to evaluate its ( cost- ) effectiveness . Methods / Design In a RCT , 692 participants will be r and omised to either the control or the intervention group . The control group will receive usual care . For the intervention group , a lifestyle intervention has been design ed based on interviews and current literature . The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts , consisting of individual counselling aim ed at increasing daily physical activity ( PA ) and improving dietary behaviour , and /or smoking cessation . Counselling will take place at the Occupational Health Service ( OHS ) , and will be done according to motivational interviewing ( MI ) . Additional written information about healthy lifestyle will also be provided to those in the intervention group . At baseline , after 6 and after 12 months , measurements will take place . Primary outcome variables will be the lifestyle behaviours of concern , i.e. daily PA , dietary intake , and smoking status . Secondary outcome variables will be body mass index ( BMI ) , systolic and diastolic blood pressure , total and HDL blood cholesterol , Hba1c and cardio-respiratory fitness ( CRF ) . Sickness absenteeism and cost-effectiveness will be assessed as well . Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group . Discussion By improving lifestyle , CVD risk may be lowered , yielding benefits for both employee and employer . If proven effective , this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry . Trial registration Current Controlled Trials IS RCT The Isfahan Healthy Heart Programme ( IHHP ) is a five to six year comprehensive integrated community-based programme for cardiovascular diseases ( CVD ) prevention and control via reducing CVD risk factors and improvement of cardiovascular healthy behaviour in a target population . IHHP started late in 1999 and will be finished in 2005 - 2006 . A primary survey was done to collect baseline data from interventional ( Isfahan and Najaf-Abad ) and reference ( Arak ) communities . In a two-stage sampling method , we r and omly selected 5 to 10 percent of households from r and omly selected clusters . Then individuals aged ≥19 years were selected for the survey . This way , data from 12,600 individuals ( 6300 in interventional counties and 6300 in the reference county ) was collected and stratified according to living area ( urban vs. rural ) and different age and sex groups . The sample s underwent a 30-minute interview to complete vali date d question naires containing questions on demography , socioeconomic status , smoking behaviour , physical activity , nutritional habits and other behaviour regarding CVD . Blood pressure and body mass index ( BMI ) measurements were done and fasting blood sample s were taken for two hours post load plasma glucose ( 2 hpp ) , serum ( total , HDL and LDL ) cholesterol and triglyceride levels . A twelve-lead electrocardiogram was recorded in all persons above 35 years of age . Community-wide surveillance of deaths , hospital discharges , myocardial infa rct ion and stroke registry was carried out in the intervention and control areas . Four to five years of interventions based on different categories such as mass media , community partnerships , health system involvement and policy and legislation have started in the intervention area while Arak will be followed without intervention . Considering the results of the baseline surveys . ( assessment s needed , the objectives , existing re sources and the possibility of national implementation ) the interventions were planned . They were set based on specific target groups like school children , women , work-site , health personnel , high-risk persons , and community leaders were actively engaged as decision makers . A series of teams was arranged for planning and implementation of the intervention strategies . Monitoring will be done on small sample s to assess the effect of different interventions in the intervention area . While four periodic surveys will be conducted on independent sample s to assess health behaviours related to CVD risk factors in the intervention and reference areas , the original pre-intervention subjects aged more than 35 years will be followed in both areas to assess the individual effect of interventions and outcomes like sudden death , fatal and nonfatal MI and stroke . The whole baseline survey will be repeated on the original and an independent sample in both communities at the end of the study AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 )
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 It is uncertain whether multiple health behaviour change ( MHBC ) interventions are effective for the primary prevention of cardiovascular disease ( CVD ) in primary care .