Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial A community based primary prevention programme for type 2 diabetes integrating identification and lifestyle intervention for prevention: the Let's Prevent Diabetes cluster randomised controlled trial. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program Comparing the effectiveness of two cardiovascular prevention programmes for highly educated professionals in general practice: a randomised clinical trial Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening A Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California. A Comprehensive Lifestyle Intervention to Prevent Type 2 Diabetes and Cardiovascular Diseases: the German CHIP Trial Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review Economic evaluation of a lifestyle intervention in primary care to prevent type 2 diabetes mellitus and cardiovascular diseases: a randomized controlled trial Cardiovascular disease markers in type 2 diabetes: the effects of a moderate home-based exercise training programme A multifaceted school-based intervention to reduce risk for type 2 diabetes in at-risk youth. Cardiovascular risk factors in type 2 diabetic patients: multifactorial intervention in primary care. Effectiveness of Systematic Health Education Model for Type 2 Diabetes Patients Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial A cluster randomised school-based lifestyle intervention programme for the prevention of childhood obesity and related early cardiovascular disease (JuvenTUM 3) No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial
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 OBJECTIVES Prevention of type 2 diabetes ( T2DM ) is a priority in healthcare , but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting . We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM  in people with pre-diabetes . MATERIAL S AND METHODS Forty-four general practice s were r and omised to receive either st and ard care or a 6hour group structured education programme with an annual refresher course , and regular phone contact . Participants were followed up for 3years . The primary outcome was progression to T2DM . RESULTS Eight hundred and eighty participants were included ( 36 % female , mean age 64years , 16 % ethnic minority group ) ; 131 participants developed T2DM . There was a non-significant 26 % reduced risk of developing T2DM in the intervention arm compared to st and ard care ( HR 0.74 , 95 % CI 0.48 , 1.14 , p=0.18 ) . The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant ( HR 0.65 , 0.41 , 1.03 , p=0.07 ) . There were statistically significant improvements in HbA1c ( -0.06 , -0.11 , -0.01 ) , LDL cholesterol ( -0.08 , -0.15 , -0.01 ) , sedentary time ( -26.29 , -45.26 , -7.32 ) and step count ( 498.15 , 162.10 , 834.20 ) when data were analysed across all time points . CONCLUSIONS This study suggests that a relatively low re source , pragmatic diabetes prevention programme result ed in modest benefits to biomedical , lifestyle and psychosocial outcomes , however the reduction to the risk of T2DM did not reach significance . The findings have important implication s for future research and primary care Background India currently has more than 60 million people with Type 2 Diabetes Mellitus ( T2DM ) and this is predicted to increase by nearly two-thirds by 2030 . While management of those with T2DM is important , preventing or delaying the onset of the disease , especially in those individuals at ‘ high risk ’ of developing T2DM , is urgently needed , particularly in re source -constrained setting s. This paper describes the protocol for a cluster r and omised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala , India . Methods / design A total of 60 polling booths are r and omised to the intervention arm or control arm in rural Kerala , India . Data collection is conducted in two steps . Step 1 ( Home screening ) : Participants aged 30–60 years are administered a screening question naire . Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic ( Step 2 ) . At the mobile clinic , participants complete question naires , undergo physical measurements , and provide blood sample s for biochemical analysis . Participants identified with T2DM at Step 2 are excluded from further study participation . Participants in the control arm are provided with a health education booklet containing information on symptoms , complications , and risk factors of T2DM with the recommended levels for primary prevention . Participants in the intervention arm receive : ( 1 ) eleven peer-led small group sessions to motivate , guide and support in planning , initiation and maintenance of lifestyle changes ; ( 2 ) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors , prevention and management ; ( 3 ) a participant h and book containing information primarily on peer support and its role in assisting with lifestyle modification ; ( 4 ) a participant workbook to guide self-monitoring of lifestyle behaviours , goal setting and goal review ; ( 5 ) the health education booklet that is given to the control arm . Follow-up assessment s are conducted at 12 and 24 months . The primary outcome is incidence of T2DM . Secondary outcomes include behavioural , psychosocial , clinical , and biochemical measures . An economic evaluation is planned . Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other re source -constrained setting s . Trial registration Australia and New Zeal and Clinical Trials Registry : ACTRN12611000262909 Background Cardiovascular disease is a major cause of mortality and morbidity and its prevalence is set to increase . While the benefits of medical and lifestyle interventions are established , the effectiveness of interventions which seek to improve the way preventive care is delivered in general practice is less so . The aim was to study and to compare the effectiveness of 2 intervention programmes for reducing cardiovascular risk factors within general practice . Methods A r and omised controlled trial was conducted in Belgium between 2007 - 2010 with 314 highly educated and mainly healthy professionals allocated to a medical ( MP ) or a medical + lifestyle ( MLP ) programme . The MP consisted of medical assessment s ( screening and follow-up ) and the MLP added a tailored lifestyle change programme ( web-based and individual coaching ) to the MP . Primary outcomes were total cholesterol , blood pressure , and body mass index ( BMI ) . The secondary outcomes were smoking status , fitness-score , and total cardiovascular risk . Results The mean age was 41 years , 95 ( 32 % ) participants were female , 7 had a personal cardiovascular event in their medical history and 3 had diabetes . There were no significant differences found between MP and MLP in primary or secondary outcomes . In both study conditions decreases of cholesterol , systolic blood pressure , and diastolic blood pressure were found . Unfavourable increases were found for BMI ( p < .05 ) . A significant decrease of the overall cardiovascular risk was reported ( p < .001 ) . Conclusions Both interventions are effective in reducing cardiovascular risk . In our population the combined medical and lifestyle programme was not superior to the medical programme . Trial registration IS RCT Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus ( T2DM ) . Latent phase identification through screening requires structured , appropriately targeted population -based approaches . Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from r and omised intervention trials in screen-detected T2DM cases . UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM . To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care . Here we describe the rationale and methods of a systematic community screening programme and r and omised controlled trial of cardiovascular risk management within a UK multiethnic setting ( ADDITION-Leicester ) . Design A single-blind cluster r and omised , parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care . Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practice s coordinated from a single academic research centre . Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40 - 75 years ( 25 - 75 years South Asian ) . Volunteers also provide detailed medical and family histories ; complete health question naires , undergo anthropometric measures , lipid profiling and a proteinuria assessment . Primary outcome is reduction in modelled Coronary Heart Disease ( UKPDS CHD ) risk at five years .  Seven thous and ( 30 % of South Asian ethnic origin ) volunteers over three years will be recruited to identify a screen-detected T2DM cohort ( n = 285 ) powered to detected a 6 % relative difference ( 80 % power , alpha 0.05 ) between treatment groups at one year . R and omisation will occur at practice -level with newly diagnosed T2DM cases receiving either conventional ( according to current national guidelines ) or intensive ( algorithmic target-driven multi-factorial cardiovascular risk intervention ) treatments . Discussion ADDITION-Leicester is the largest multiethnic ( targeting > 30 % South Asian recruitment ) community T2DM and vascular risk screening programme in the UK . By assessing feasibility and efficacy of T2DM screening , it will inform national disease prevention policy and contribute significantly to our underst and ing of the health care needs of UK South Asians . Trial registration Clinical trial.gov ( NCT00318032 ) BACKGROUND It has been demonstrated in previous studies that pharmacist management of patients with type 2 diabetes mellitus ( T2DM ) in the outpatient setting not only improves diabetes-related clinical outcomes such as hemoglobin A1c but also blood pressure ( BP ) , total cholesterol ( TC ) , and quality of life . Improved control of BP and TC has been shown to reduce the risks of cardiovascular disease ( CVD ) , which has placed a heavy economic burden on the health care system . However , no study has evaluated the cost-effectiveness of pharmacist intervention programs with respect to the long-term preventive effects on CVD outcomes among T2DM patients . OBJECTIVES To ( a ) quantify the long-term preventive effects of pharmacist intervention on CVD outcomes among T2DM patients using evidence from a matched cohort study in the outpatient primary care setting and ( b ) assess the relative cost-effectiveness of adding a clinical pharmacist to the primary care team for the management of patients with T2DM based on improvement in CVD risks with the aid of an economic model . METHODS Clinical data between the periods of June 2007 to February 2010 were collected from electronic medical records at 2 separate clinics at Kaiser Permanente ( KP ) Northern California , 1 with primary care physicians only ( control group ) and the other with the addition of a pharmacist ( enhanced care group ) . Patients in the enhanced care group were matched 1:1 with patients in the control group according to baseline characteristics that included age , gender , A1c , and Charlson comorbidity score . The estimated 10-year CVD risk for both groups was calculated by the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Risk Engine ( version 2 ) based on age , sex , race , smoking status , atrial fibrillation , duration of diabetes , levels of A1c , systolic BP ( SBP ) and TC , and high-density lipoprotein cholesterol ( HDL-C ) observed at 12 months . There was no statistical difference in the baseline clinical inputs to the Risk Engine ( A1c [ P=0.115 ] , SBP [ P=0.184 ] , TC [ P=0.055 ] , and HDL-C [ P=0.475 ] ) between the 2 groups . A Markov model was developed to simulate the estimated CVD outcomes over 10 years and to estimate cost-effectiveness . The final outcomes examined included incremental cost and effectiveness measured by life years and per quality -adjusted life year gained . Both deterministic sensitivity analysis ( SA ) and probabilistic SA were conducted to examine the robustness of the results . RESULTS The estimated risks for coronary heart disease ( CHD ) and stroke ( both nonfatal and fatal ) at the end of the follow-up were consistently lower in the enhanced care group compared with the control group , even though baseline risks in both groups were similar . The absolute risk reduction ( ARR ) between the enhanced care and control groups increased over time . For example , the ARR for nonfatal CHD risk in year 1 was 0.5 % ( 1.2 % vs. 0.7 % ) , whereas the ARR increased to 5.5 % in year 10 ( 14.8 % vs. 9.3 % ) . Similarly , the ARR between the enhanced care and the control groups was calculated as 0.3 % for fatal CHD in year 1 and increased to 4.6 % in year 10 . Results from the Markov model suggest that the enhanced care group was shown to be a dominant strategy ( less expensive and more effective ) compared with the control group in the 10-year evaluation period in the base-case ( average or mean results ) scenario . Sensitivity analysis that took into account the uncertainty in all important variables , such as wage of pharmacists , utility weight ( the degree of preference individuals have for a particular health state or condition ) , response rate to pharmacists ' care , and uncertainty associated with the estimated 10 years of CVD risk , revealed that the relative value of enhanced care was robust to most of the variations in these parameters . Notably , the level of cost-effectiveness measured by net monetary value depends on the time horizon adopted by the payers and the magnitude of CVD risk reduction . The enhanced care group has a higher chance of being considered as a cost-effective strategy when a longer time horizon such as a minimum of 4 to 5 years is adopted . CONCLUSIONS Adding pharmacists to the health care management team for diabetic patients improves the long-term CVD risks . The longer-term CVD risk reductions were shown to be more dramatic than the short-term reduction . A longer time horizon adopted by health plans in managing T2DM patients has a higher probability of making the intervention cost-effective The prevalence of type 2 diabetes is continuously increasing . This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system . In view of the fact that type 2 diabetes is primarily caused by behavioral factors , effective preventive strategies are urgently needed . We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes . We conducted a r and omized controlled trial in a primary care setting in Hannover , Germany , with 83 patients diagnosed as (pre)diabetic or at risk for diabetes . CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases . The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach . The primary outcome parameter was the body mass index ( BMI ) . Secondary outcome parameters included body weight , blood pressure , fasting glucose , HbA1c , blood lipids , and the FINDRISK score , which assesses long-term diabetes risk . At the final measurement after 12 months , in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m2 in controls ( p = .119 ) . The mean sustained weight loss after 12 months was −4.1 kg in the intervention group versus −0.8 kg in controls . Furthermore , we found a trend toward a stronger reduction in blood pressure , fasting glucose , and HbA1c as well as an improved FINDRISK score in the intervention group , compared to controls . Although failing to reach statistical significance at the final assessment , this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 Background Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases , addressing ‘ real-world ’ implementation , are needed . This study examines the cost-effectiveness of a primary care intervention from a societal perspective , compared with provision of health brochures , alongside a r and omized controlled trial . Methods Adults aged 30 - 50 years , at risk of type 2 diabetes ( T2DM ) and /or cardiovascular disease ( CVD ) , were recruited from twelve general practice s in The Netherl and s. They were r and omized to the intervention ( n = 314 ) or control group ( n = 308 ) . The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse , followed by three-monthly sessions by phone . Costs were collected using three-monthly retrospective question naires . Quality of life was measured with the EuroQol-5D-3L , at baseline , 6 , 12 and 24 months . Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae , respectively , based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points . Results Small , statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years ( QALYs ) gained . The mean difference in costs between the intervention and control group was € -866 ( 95 % confidence interval -2372 ; 370 ) . The probability that the intervention was cost-effective varied from 93 % at € 8000/QALY to 88 % at € 80,000/QALY . Conclusion A primary care lifestyle intervention aim ed at adults at increased risk of T2DM and /or CVD  could result in cost savings over a two-year period . However , due to method ological uncertainty no advice can be given regarding the implementation of the intervention in Dutch general practice s . Trial registration Current Controlled Trials IS RCT N59358434 Patients with T2DM have an increased risk of CVD . Prevention of CVD represents the major goal of all treatment of T2DM , and early intervention in those patients at particularly high risk is important . We measured the insulin sensitivity and plasma biomarkers of CVD to determine whether a home-based exercise training program improves biomarker levels and insulin sensitivity . Patients with T2DM ( n=12 ) , IGT ( n=4 ) and healthy control subjects ( n=9 ) were studied before and after eight weeks of exercise training by rowing ergometry at 65—70 % of peak oxygen uptake . Conclusions : 1 ) patients with T2DM have elevated plasma concentrations of CVD biomarkers compared to the matched control and IGT groups ; 2 ) a moderate to vigorous intensity home-based training program did not reduce plasma concentrations of these CVD markers ; 3 ) insulin sensitivity improved as a result of exercise training in the control group , but not in the T2DM group OBJECTIVE To evaluate the impact of a multifaceted , school-based intervention on inner city youth at high risk for type 2 diabetes mellitus ( T2DM ) and to determine whether the addition of coping skills training ( CST ) and health coaching improves outcomes . METHOD 198 students in New Haven , CT at risk for T2DM ( BMI > 85th percentile and family history of diabetes ) were r and omized by school to an educational intervention with or without the addition of CST and health coaching .  Students were enrolled from 2004 to 2007 and followed for 12 months . RESULTS Students in both groups showed some improvement in anthropometric measures , lipids , and depressive symptoms over 12 months . BMI was not improved by the intervention . Students who received CST showed greater improvement on some indicators of metabolic risk than students who received education only . CONCLUSION A multifaceted , school-based intervention may hold promise for reducing metabolic risk in urban , minority youth BACKGROUND Cardiovascular disease is the main cause of morbidity and mortality in patients with type 2 diabetes mellitus ( DM ) . Intervention on  cardiovascular risk factors  ( CVRF ) is essential to obtain clinical results reducing the excess of cardiovascular risk ( CVR ) in these patients . METHODS The objective of this study was to describe the association of type 2 DM with modifiable cardiovascular risk factors and the degree of control of these in a population of type 2 diabetics in attendance in primary care clinics , and also to establish prospect ively whether an integral and multifactorial intervention on uncontrolled cardiovascular risk factors , carried out in conditions of routine clinical practice by applying an open protocol , could significantly reduce the estimated CVR according to the Framingham scale . The proposed intervention included both actions aim ed at modifying habits , and pharmacologic intervention to achieve an optimum level of control in accordance with international recommendations for the objectives and treatment for type 2 diabetes . RESULTS A total of 3466 patients with a mean age of 58 + /- 7.5 years were studied and followed-up for 1 year . Of these , 90.4 % of patients had high blood pressure ; 60.1 % of men and 32.7 % of women presented CVR > 20 % in 10 years according to the Framingham scale by categories . Intervention at 1 year of follow-up had achieved statistically significant reductions in blood pressure , glycated hemoglobin , and lipid levels , but not of patients ' body weight . After 1 year of follow-up , 29 % of males and 24 % of women with a high CVR ( > 20 % ) at the start of the study presented reduced risk levels . CONCLUSION The results of the study demonstrate that an integrated and multifactorial intervention in type 2 diabetic patients can achieve clinical ly significant reductions in CVR . However , conducted in effective conditions , it is not able to achieve optimum levels of control in spite of the initial proposal , possibly due to some degree of inertia in routine clinical practice Background Health education is considered to be essential in the overall care of patients with type 2 diabetes mellitus ( T2DM ) ;  systematic health education integrates individual education not only during hospitalization but also extended care outside of a hospital . To test effectiveness of the systematic health education model for T2DM , we conducted a r and omized study with a control group among patients with T2DM living in Nanjing , China . Methods 998 eligible patients completed the enrollment and were r and omized to systematic health education model and conventional model groups ( 498 and 500 patients , resp . ) . The systematic health education model was based on the following aspects : image education , visitation of the exhibition hall , dissemination of educational material s , individualized medical nutrition therapy and exercise programs , WeChat group and regular health lectures , evaluation of complications , lifestyle modification , systematic treatment scheme , self-monitoring of glycemic control , monthly evaluation of the therapeutic effect , proposed improvement measures , and individualized follow-up scheme . The main outcome measures were glycated hemoglobin A1c ( HbA1c ) , blood pressure , body mass index ( BMI ) , and lipids during the 2-year follow-up . Results The systematic health education model led to a favorable variation in HbA1c , LDL cholesterol , and systolic blood pressure ( SBP ) ( P < 0.05 ) . After adjusted analysis , the HbA1c decreased by 0.67 % ( P < 0.01 ) in the systematic health education model , SBP decreased by 10.83 mmHg ( P < 0.01 ) , and the level of diastolic blood pressure ( DBP ) , HDL cholesterol , and total cholesterol decreased slightly and was not significant . The BMI did not change significantly during the study in either of the two groups . Conclusions The systematic health education model is a useful method in the treatment of T2DM because it contributes to decrease in HbA1c , LDL cholesterol , and SBP levels , as well as helps in increasing the compliance with the control criteria , except for DBP and BMI Background Individual health education is considered to be essential in the overall care of patients with type 2 diabetes ( DM2 ) , although there is some uncertainty regarding its metabolic control benefits . There have been very few r and omized studies on the effects of individual education on normal care in DM2 patients with a control group , and none of these have assessed the long-term results . Therefore , this study aims to use this design to assess the effectiveness of the PRECEDE ( Predisposing , Reinforcing , Enabling , Causes in Educational Diagnosis , and Evaluation ) education model in the metabolic control and the reduction of cardiovascular risk factors , in patients with type 2 diabetes . Methods An open community effectiveness study was carried out in 8 urban community health centers in the North-East Madrid Urban Area ( Spain ) . Six hundred patients with DM2 were r and omized in two groups : PRECEDE or conventional model for health promotion education . The main outcome measures were glycated hemoglobin A1c , body mass index ( BMI ) , blood pressure , lipids and control criteria during the 2-year follow-up period . Results Glycated hemoglobin A1c and systolic blood pressure ( SBP ) levels decreased significantly in the PRECEDE group ( multivariate analysis of covariance , with baseline glycated hemoglobin A1c , SBP , and variables showing statistically significant differences between groups at baseline visits ) . The decrease levels in diastolic blood pressure ( DBP ) , triglycerides and LDL cholesterol were nonsignificant . PRECEDE increased compliance in all control criteria , except for LDL cholesterol . BMI did not change during the study in either of the two models analyzed . Conclusions PRECEDE health education model is a useful method in the overall treatment in patients with type 2 diabetes , which contributes to decrease glycated hemoglobin A1c and SBP levels and increase the compliance in all the control criteria , except for LDL cholesterol . Trial registration number Clinical Trials.gov 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 Childhood obesity is not only associated with adult obesity but also with increased risk of adult onset of type 2 diabetes and subsequent coronary heart disease . The potential effects of school-based health intervention programmes on cardiovascular risk and surrogate markers are unclear , as only few studies have attempted to investigate a complete risk profile including a detailed laboratory analysis or micro- and macrovascular function . In this study a comprehensive school-based r and omized intervention programme will be investigated in 10 - 14-year old children addressing the influence of lifestyle intervention on inactivity , cardiometabolic risk factors and early signs of vascular disease . Methods / Design 15 secondary schools in Southern Germany are r and omly assigned to intervention or control schools . Children in the fifth grade ( 10 - 11 years ) will be observed over four years . The study combines a school-based with a home-based approach , aim ing at children , teachers and parents . The main components are weekly lifestyle-lessons for children , taught by regular classroom teachers to increase physical activity in- and outside of school , to improve eating patterns at school and at home , to reduce media consumption and to amplify well-being . In 4 - 6 annual meetings , teachers receive information about health-related topics with worksheets for children and supporting equipment , accounting for school-specific needs and strategies . Parents ' trainings are provided on a regular basis . All examinations are performed at the beginning and at the end of every school year . Anthropometry includes measurements of BMI , waist and upper arm circumferences , skinfold thickness as well as peripheral blood pressure . Blood sampling includes lipid parameters , insulin , glucose , hsCRP , adiponectin , and IL-6 as well as testosteron and estrogen to determine maturation status . Vascular function is non-invasively assessed by measuring arterial stiffness in large arteries using a sphygmograph and by analysing arteriolar and venular diameters in the retinal microcirculation using a non-mydriatric vessel analyser . A question naire is filled out to determine daily physical activity , motivational factors , dietary habits , quality of life ( KINDL-R ) and socio-economic data . Physical fitness is assessed by a six-item test battery . Discussion Our study aims to provide a feasible long-term intervention strategy to re-establish childhood health and to prevent obesity-related cardiovascular dysfunction in children . Trial Registration Background People with Familial Hypercholesterolemia ( FH ) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia . This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids ( low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , total cholesterol ( TC ) and triglycerides ) , systolic blood pressure , glucose , body mass index ( BMI ) and waist circumference in people with FH . Methods Adults with FH ( n = 340 ) , recruited from a Dutch cascade screening program , were r and omly assigned to either a control group or an intervention group . The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling . The control group received care as usual .  Lipids , systolic blood pressure , glucose , BMI , and waist circumference were measured at baseline and after 12 months . Regression analyses were conducted to examine differences between both groups . Results After 12 months , no significant between-group differences of cardiovascular disease ( CVD ) risk indicators were observed . LDL-C levels had decreased in both the intervention and control group . This difference between intervention and control group was not statistically significant . Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH . The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies .Trial registration NTR1899 at
Community-based programmes achieved good results for most risk factors except BMI and ( glycated haemoglobin ) HbA1c .
INTRODUCTION Although cardiovascular disease ( CVD ) and type 2 diabetes mellitus ( T2DM ) prevention programmes have been effective in urban residents , their effectiveness in non-urban setting s , where cardio-metabolic risk is typically elevated , is unknown .
We systematic ally review ed the effectiveness of primary prevention programmes aim ed at reducing risk factors for CVD/T2DM , including blood pressure , body mass index ( BMI ) , blood lipid and glucose , diet , lifestyle , and knowledge in adults residing in non-urban areas .