Prevention of type 2 diabetes - where is the evidence? The clinical application of genetic testing in type 2 diabetes: a patient and physician survey 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 Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial A randomized trial of the clinical utility of genetic testing for obesity: Design and implementation considerations 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 What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol 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 The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial The Sydney Diabetes Prevention Program: A community-based translational study Impact of Positive Family History and Genetic Risk Variants on the Incidence of Diabetes Examining the theory‐effectiveness hypothesis: A systematic review of systematic reviews Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial Psychological responses to genetic testing for weight gain: a vignette study. Identifying effective behavioural components of Intervention and Comparison group support provided in SMOKing cEssation (IC-SMOKE) interventions: a systematic review protocol Cohort Profile: The Korean Genome and Epidemiology Study (KoGES) Consortium Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program Globalization of Diabetes Do sugar-sweetened beverages cause adverse health outcomes in children? A systematic review protocol The effect of different cardiovascular risk presentation formats on intentions, understanding and emotional affect: a randomised controlled trial using a web-based risk formatter (protocol) Behavioural interventions for type 2 diabetes: an evidence-based analysis. Systematic Review: Family History in Risk Assessment for Common Diseases The contribution of lifestyle coaching of overweight patients in primary care to more autonomous motivation for physical activity and healthy dietary behaviour: results of a longitudinal study
Diabetes is an “ old disease ” . The first description of diabetes written on papyrus about 3500 years ago is found in the Ebers papyrus  , which was discovered in Egypt in 1873 by the German archeologist Georg Ebers . Humans , like most mammals , may develop diabetes , if sufficient environmental exposure to physical inactivity , unhealthy diet and obesity are present . Genetic effects are important for the individual risk of type 2 diabetes ( T2D ) but twin studies have shown that the genetic effects combined explain less than 50 % of the risk of T2D ( 1 ) . Today we know almost 100 susceptibility genes associated with T2D but the relative importance of each of these genes is low ( 2 ) , and together they explain only a small part of the disease risk . Thus , genetic screening can not be used for the prediction of T2D for individuals . On the other h and , healthy lifestyle can also prevent T2D in people who are genetically at high risk , e.g. those with positive family history ( 3 ) . Thus , the importance of lifestyle factors for the development and prevention of T2D is overwhelming . The strongest evidence in medicine is considered to come from r and omized controlled trials ( RCTs ) . They are also important in providing the link to causal inference that in most observational studies can not be derived . At the same time , observational studies are necessary for the identification of factors associated with an increased or decreased risk of a disease , and for generation of hypotheses on potential means for prevention based on modifiable risk factors . Observational studies have by now identified a large number of factors that are associated with the development of T2D or with the protection against it . Most of them are related to physical activity , diet and obesity . It has also been shown unequivocally that exposures ( poor nutrition , infections , smoking , etc . ) during fetal life and early infancy result ing in insufficient development ( often shown as low birth weight ) also predict T2D later in life ( 4 ) . Traditionally , T2D has been considered to be a disease of the elderly . However , with increasing obesity and sedentary lifestyle in children , there are increasing numbers of cases of T2D already occurring at a young age in many population s ( 5 ) . In the past two decades several innovative RCTs have repeatedly shown that interventions on modifiable risk factors can reduce the incidence of diabetes in high-risk groups . The evidence has been summarized in several systematic review s and meta-analyses ( 6,7 ) . There is compelling scientific evidence from RCTs that T2D can be prevented or its onset delayed . The key for prevention is a multimodal package of lifestyle changes that is a sum outcome of dietary and physical activity behaviours . The power of lifestyle was dramatically illustrated by the Finnish Diabetes Prevention Study ( DPS ) that explicitly showed that when the study participants with impaired glucose tolerance reached all five modest lifestyle intervention targets , none of them progressed to T2D ( 8) . Importantly , lifestyle intervention lasting for 3–6 years has been shown to have a carry-over effect on T2D incidence that lasts for several years ; up to 15 in the Finnish Diabetes Prevention Study ( 9 ) and 20 years in the China Da Qing Diabetes Prevention Study ( 10 ) . The observed sustained risk reduction seems to be a result of sustained lifestyle changes , but the legacy effect of improved glycaemia during the early intervention may also have contributed to the long-term effect . The follow-up data from the Chinese study indicate moreover that vascular risks are also reduced by lifestyle management . Several prognostic question naires exist for detecting people at risk of T2D ( 11 ) . One of the screening tools with an adequately high sensitivity and specificity is the Finnish Diabetes Risk Score ( FINDRISC ) developed in Finl and ( 12 ) . The FINDRISC has been successfully implemented in the Finnish primary health care system and used also in many other countries . The FINDRISC was also tested in the Omani population and as a result a slightly modified Omani Diabetes Risk Score was developed ( 13 ) which may be a suitable screening tool for the Arab population s in the Middle East . Lifestyle interventions aim ing at translating evidence from efficacy RCTs on T2D prevention into “ real world ” intervention programmes have also been carried out in various population s. Such data were recently combined in a meta- analysis considering the relationship between intervention effectiveness and adherence to guidelines ( 14 ) . The primary meta- analysis included 22 studies with outcome data for weight loss at 12 months . The pooled result of the direct pairwise meta- analysis shows that Aims /hypothesisAdvances in type 2 diabetes genetics have raised hopes that genetic testing will improve disease prediction , prevention and treatment . Little is known about current physician and patient views regarding type 2 diabetes genetic testing . We hypothesised that physician and patient views would differ regarding the impact of genetic testing on motivation and adherence . Methods We surveyed a nationally representative sample of US primary care physicians and endocrinologists ( n = 304 ) , a r and om sample of non-diabetic primary care patients ( n = 152 ) and patients enrolled in a diabetes pharmacogenetics study ( n = 89 ) . Results Physicians and patients favoured genetic testing for diabetes risk prediction ( 79 % of physicians vs 80 % of non-diabetic patients would be somewhat/very likely to order/request testing , p = 0.7 ) . More patients than physicians ( 71 % vs 23 % , p < 0.01 ) indicated that a ‘ high risk ’ result would be very likely to improve motivation to adopt preventive lifestyle changes . Patients favoured  genetic testing to guide therapy ( 78 % of patients vs 48 % of physicians very likely to request/recommend testing , p < 0.01 ) and reported that genetic testing would make them ‘ much more motivated ’ to adhere to medications ( 72 % vs 18 % of physicians , p < 0.01 ) . Many physicians ( 39 % ) would be somewhat/very likely to order genetic testing before published evidence of clinical efficacy . Conclusions /interpretationDespite the paucity of current data , physicians and patients reported high expectations that genetic testing would improve patient motivation to adopt key behaviours for the prevention or control of type 2 diabetes . This suggests the testable hypothesis that ‘ genetic ’ risk information might have greater value to motivate behaviour change compared with st and ard risk information 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 Type 2 diabetes ( T2D ) is associated with increased risk of morbidity and premature mortality . Among those at high risk , incidence can be halved through healthy changes in behaviour . Information about genetic and phenotypic risk of T2D is now widely available . Whether such information motivates behaviour change is unknown . We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours , anxiety , and other cognitive and emotional theory-based antecedents of behaviour change . In a parallel group , open r and omised controlled trial , approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population -based , observational Fenl and Study ( Cambridgeshire , UK ) . Eligible participants will have undergone clinical , anthropometric , and psychosocial measurements , been genotyped for 23 single-nucleotide polymorphisms associated with T2D , and worn a combined heart rate monitor and accelerometer ( Actiheart ® ) continuously for six days and nights to assess physical activity .  Participants are r and omised to receive either st and ard lifestyle advice alone ( control group ) , or in combination with a genetic or a phenotypic risk estimate for T2D ( intervention groups ) . The primary outcome is objective ly measured physical activity . Secondary outcomes include self-reported diet , self-reported weight , intention to be physically active and to engage in a healthy diet , anxiety , diabetes-related worry , self-rated health , and other cognitive and emotional outcomes . Follow-up occurs eight weeks post-intervention . Values at follow-up , adjusted for baseline , will be compared between r and omised groups . This study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D . Importantly , it will be among the first to examine the impact of genetic risk information using a r and omised controlled trial design , a population -based sample , and an objective ly measured behavioural outcome . Results of this trial , along with recent evidence syntheses of similar studies , should inform policy concerning the availability and use of genetic risk information . Current Controlled Trials IS RCT Background Obesity rates in the United States have escalated in recent decades and present a major challenge in public health prevention efforts . Currently , testing to identify genetic risk for obesity is readily available through several direct-to-consumer companies . Despite the availability of this type of testing , there is a paucity of evidence as to whether providing people with personal genetic information on obesity risk will facilitate or impede desired behavioral responses . Purpose We describe the key issues in the design and implementation of a r and omized controlled trial examining the clinical utility of providing genetic risk information for obesity . Methods Participants are being recruited from the Coriell Personalized Medicine Collaborative , an ongoing , longitudinal research cohort study design ed to determine the utility of personal genome information in health management and clinical decision making . The primary focus of the ancillary Obesity Risk Communication Study is to determine whether genetic risk information added value to traditional communication efforts for obesity , which are based on lifestyle risk factors . The trial employs a 2 × 2 factorial design in order to examine the effects of providing genetic risk information for obesity , alone or in combination with lifestyle risk information , on participants ’ psychological responses , behavioral intentions , health behaviors , and weight . Results The factorial design generated four experimental arms based on communication of estimated risk to participants : ( 1 ) no risk feedback ( control ) , ( 2 ) genetic risk only , ( 3 ) lifestyle risk only , and ( 4 ) both genetic and lifestyle risk ( combined ) . Key issues in study design pertained to the selection of algorithms to estimate lifestyle risk and determination of information to be provided to participants assigned to each experimental arm to achieve a balance between clinical st and ards and method ological rigor . Following the launch of the trial in September 2011 , implementation challenges pertaining to low enrollment and differential attrition became apparent and required immediate attention and modifications to the study protocol . Although monitoring of these efforts is ongoing , initial observations show a doubling of enrollment and reduced attrition . Limitations The trial is evaluating the short-term impact of providing obesity risk information as participants are followed for only 3 months . This study is built upon the structure of an existing personalized medicine study wherein participants have been provided with genetic information for other diseases . This nesting in a larger study may attenuate the effects of obesity risk information and has implication s for the generalizability of study findings . Conclusions This r and omized trial examines value of obesity genetic information , both when provided independently and when combined with lifestyle risk assessment , to motivate individuals to engage in healthy lifestyle behaviors . Study findings will guide future intervention efforts to effectively communicate genetic risk information 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 Introduction Large proportions of the population are not meeting recommended levels of physical activity and have increasingly sedentary lifestyles . Low levels of physical activity are predictive of poor health outcomes and time spent sedentary is related to a host of risk factors independently of physical activity levels . Building an evidence base of the best approaches to intervene in the lifestyles of inactive individuals is crucial in preventing long-term disease , disability and higher mortality rates . Methods and analysis Systematic search es will be conducted on all relevant data bases ( eg , PubMed , Scopus , CINAHL , PsycINFO ) . Studies will be included if they assess interventions aim ed at changing physical activity or sedentary behaviour levels in adults ( over 18 ) who are inactive and do not suffer from chronic conditions . Studies must also be r and omised controlled trials ( RCTs ) , have a primary outcome of physical activity or sedentary behaviour , and measure outcomes at least 6 months after intervention completion . Studies will be coded using the Behaviour Change Technique ( BCT ) taxonomy v1 and Template for Intervention Description and Replication ( TIDieR ) guidelines . 2 review ers will independently screen full-text articles and extract data on study characteristics , participants , BCTs , intervention features and outcome measures . Study quality will also be assessed independently by 2 review ers using the Cochrane risk of bias tool . A meta- analysis will be considered if there is sufficient homogeneity across outcomes . GRADE criteria will be used to assess quality of evidence . Dissemination This will be the first review to systematic ally appraise interventions aim ed at changing the physical activity or sedentary behaviour of inactive individuals using RCT design s with a 6-month follow-up post-intervention . This review will better inform intervention design ers targeting inactive population s and inform the design of a future complex intervention . Review registration number This protocol was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) on 17 October 2014 ( registration number : CRD42014014321 ) 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 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 Type 2 diabetes is a major public health problem in Australia with prevalence increasing in parallel with increasing obesity . Prevention is an essential component of strategies to reduce the diabetes burden . There is strong and consistent evidence from r and omised controlled trials that type 2 diabetes can be prevented or delayed through lifestyle modification which improves diet , increases physical activity and achieves weight loss in at risk people . The current challenge is to translate this evidence into routine community setting s , determine feasible and effective ways of delivering the intervention and providing on-going support to sustain successful behavioural changes . Methods / Design The Sydney Diabetes Prevention Program ( SDPP ) is a translational study which will be conducted in 1,550 participants aged 50 - 65 years ( including 100 indigenous people aged 18 years and older ) at high risk of future development of diabetes . Participants will be identified through a screening and recruitment program delivered through primary care and will be offered a community-based lifestyle modification intervention . The intervention comprises an initial individual session and three group sessions based on behaviour change principles and focuses on five goals : 5 % weight loss , 210 min/week physical activity ( aerobic and strength training exercise ) , limit dietary fat and saturated fat to less than 30 % and 10 % of energy intake respectively , and at least 15 g/1000 kcal dietary fibre . This is followed by 3-monthly contact with participants to review progress and offer ongoing lifestyle advice for 12 months . The effectiveness and costs of the program on diabetes-related risk factors will be evaluated . Main outcomes include changes in weight , physical activity , and dietary changes ( fat , saturated fat and fibre intake ) . Secondary outcomes include changes in waist circumference , fasting plasma glucose , blood pressure , lipids , quality of life , psychological well being , medication use and health service utilization . Discussion This translational study will ascertain the reach , feasibility , effectiveness and cost-effectiveness of a lifestyle modification program delivered in a community setting through primary health care . If demonstrated to be effective , it will result in recommendations for policy change and practical methods for a wider community program for preventing or delaying the onset of type 2 diabetes in high risk people OBJECTIVE We aim ed to investigate the influence of positive family history ( FH+ ) of diabetes and 19 known genetic risk loci on the effectiveness of lifestyle changes and their predictive value on the incidence of type 2 diabetes  in the Finnish Diabetes Prevention Study ( DPS ) . RESEARCH DESIGN AND METHODS A total of 522 subjects with impaired glucose tolerance ( IGT ) were r and omized into the control ( n = 257 ) and intervention ( n = 265 ) groups . The mean follow-up was 6.2 years ( median 7 years ) , and the lifestyle intervention , aim ed at  weight reduction , healthy diet , and increased physical activity  , lasted for 4 years ( range 1–6 years ) . An oral glucose tolerance test ( OGTT ) and assessment of basic clinical variables were performed annually . RESULTS The effect of intervention on the incidence of diabetes was almost similar in subjects with FH+ compared with subjects with a negative family history ( FH− ) of diabetes during the entire follow-up . In the Cox model , including FH , genetic risk SNPs , and r and omization group , and adjusted for the effects of age , sex , BMI , and study center , only lifestyle intervention had a significant effect ( hazard ratio 0.55 , 95 % CI 0.41–0.75 , P < 0.001 ) on the incidence of diabetes . Further analyses showed that in addition to the baseline glucose and insulin values , 1-year changes in 2-h glucose and 2-h insulin achieved by lifestyle intervention had a significant effect on the incidence of diabetes . CONCLUSIONS These results emphasize the effectiveness of  lifestyle intervention  in reducing the risk of diabetes in high-risk individuals independently of genetic or familial risk of type 2 diabetes PURPOSE Health interventions based on theory may be more effective than those that are not . This review of review s synthesizes all published r and omized controlled trial ( RCT ) meta-analytic evidence from the last decade to examine whether theory-based interventions were found to be associated with more effective  adult health behaviour change interventions . METHODS Systematic review s including meta-analyses were identified by search ing Medline , CINAHL , PsycINFO , and CDSR . A narrative synthesis was used to summarize and analyse the evidence . Only review s including RCTs of health behaviour change interventions with adults aged 18 + published from 2007 to 2017 were included . RESULTS Of 8,659 articles , nine systematic review s met inclusion criteria . The majority of review s ( n = 8) suggested no increased effectiveness for theory-based compared to non-theory-based interventions for effectiveness of outcomes relating to health behaviour . Less than half of the RCTs included in the review s reported the use of theory ( 85/183 ) . Two review s suggested interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Method ological and reporting issues limit the conclusions . CONCLUSIONS Theory-based interventions as currently operationalized in systematic review s were not found to be more effective than non-theory-based interventions . Method ological and reporting issues at study and review level may not reflect the true utility of theory use within health behaviour interventions . The promotion of theory use may benefit from using a multifaceted argument , rather than a narrow focus of increased effectiveness . Statement of contribution What is already known on this subject ? Theory use is regularly promoted by cl aim ing that it will lead to more effective behaviour change interventions . Theory use has been frequently linked to effectiveness within systematic review s of behaviour change interventions . The theory-effectiveness hypothesis has not been systematic ally examined at the systematic review level . What does this study add ? Theory use as operationalized by systematic review authors was not associated with increased effectiveness within systematic review s examining r and omized controlled trials of behaviour change interventions in adults . Interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Theory use should be promoted using a multifaceted argument , and assertions for increased effectiveness of theory-based interventions should only be used in domains where specific evidence exists to support this cl aim 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 Genetic testing for obesity risk is increasingly available to the public but few studies have examined motivational or affective reactions . Here we report findings from a " vignette " study investigating reactions to " higher-risk " and " average-risk " results for the obesity-related FTO gene in two groups : a panel sample of individuals with weight concerns , for whom testing may have treatment implication s ( n = 306 , mean age = 45 years , mean BMI = 35 ) and a student sample ( n = 395 , mean age = 25 years , mean BMI = 23 ) , for whom testing would have implication s for obesity prevention . Participants were given FTO gene information that described higher-risk alleles as linked with modest weight gain and slightly higher risk of obesity . They responded to both higher- and average-risk vignettes , with order r and omized . Interest in genetic testing was high overall , and higher in panel respondents than students ( 93 % vs. 78 % would " probably " or " definitely " have the test ; P < 0.001 ) . In students , a higher-risk result generated higher motivation to change ( d = 0.15 ; P < 0.001 ) , but also slightly higher negative affect ( d = 0.03 , P < 0.001 ) and fatalism ( d = 0.05 , P < 0.001 ) than an average-risk result . Panel respondents also had higher motivation to change ( d = 0.17 , P < 0.001 ) as well as relief about having an explanation for their body weight ( d = 0.02 , P = 0.013 ) in the higher-risk condition , but no increase in fatalism or depression . These results suggest that at the level of anticipated responses to FTO gene feedback , higher-risk results had positive motivational effects with minimal changes in negative affect or fatalism . Genetic testing has the potential to be a useful clinical or preventive tool when combined with appropriate information Background Systematic review s of behaviour change interventions for  smoking cessation  vary in scope , quality , and applicability . The current review aims to generate more accurate and useful findings by ( 1 ) a detailed analysis of intervention elements that change behaviour ( i.e. behaviour change techniques ( BCTs ) ) and potential moderators of behaviour change ( i.e. other intervention and sample characteristics ) and ( 2 ) assessing and controlling for variability in support provided to comparison groups in smoking cessation trials . Methods A systematic review will be conducted of r and omized controlled trials of behaviour change interventions for smoking cessation in adults ( with or without pharmacological support ) , with a minimum follow-up of 6 months , published after 1995 . Eligible articles will be identified through the Cochrane Tobacco Addiction Group Specialized Register . Study authors will be asked for detailed descriptions of smoking cessation support provided to intervention and comparison groups . All data will be independently coded by two research ers . The BCT taxonomy v1 ( tailored to smoking cessation interventions ) and template for intervention description and replication criteria will be used to code intervention characteristics . Data collection will further include sample and trial characteristics and outcome data ( smoking cessation rates ) . Multilevel mixed-effects meta-regression models will be used to examine which BCTs and /or BCT clusters delivered to intervention and comparison groups explain smoking cessation rates in treatment arms ( and effect sizes ) and what key moderators of behaviour change are . Predicted effect sizes of each intervention will be computed assuming all interventions are compared against comparison groups receiving the same levels of behavioural support ( i.e. low , medium , and high levels ) . Multi-disciplinary advisory board members ( policymakers , health care providers , and (ex-)smokers ) will provide strategic input throughout the project to ensure the review ’s applicability to policy and practice . Discussion By capturing BCTs in intervention and comparison groups , this systematic review will provide more accurate estimates of the effectiveness of smoking cessation interventions , the most promising BCTs and /or BCT clusters associated with smoking cessation rates in intervention and comparison arms , and important moderators of behaviour change . The results could set new st and ards for conducting meta-analyses of behaviour change interventions and improve research , service delivery , and training in the area of smoking cessation . Systematic review registration PROSPERO Worldwide globalization and Westernization in social and economic aspects have led to drastic changes in South Korea during the past several decades . These changes include individual health behaviours , which were reflected as increased prevalence of non-communicable chronic diseases ( NCDs ) , such as type 2 diabetes mellitus ( T2DM ) , hypertension , obesity and cardiovascular disease ( CVD ) . These NCDs are known to be caused by both environmental risk factors and predisposing genetic factors . Population decline is another issue in South Korea ; the recorded fertility rate was 1.3 births per woman , and 10 % of the population were elderly individuals aged 65 years according to the Population and Housing Census results of 2005 - 2010 . We have also been observing an increased influx and efflux of the population due to globalization . In particular , there has been a rising tendency in the marriage-based inflow of South Asian women during the last decade . To attempt to solve public health issues result ing from these population trends and prepare for personalized and preventive health care in the future , the Korean government ( National Research Institute of Health ( NIH ) , Centers for Disease Control and Prevention and the Ministry of Health and Welfare , Korea ) initiated a large prospect i ve cohort study with government funding , named the Korean genome and epidemiology study ( KoGES ) . The study is a consortium project consisting of six prospect i ve cohort studies that would be categorized into population -based and geneenvironment model studies ( Figure 1 ) . The aim of the KoGES was to establish a genome epidemiological study platform for the research community with a health data base and biobank , to investigate the genetic and environmental aetiology of common complex diseases in Koreans ( i.e. T2DM , hypertension , obesity , metabolic syndrome , osteoporosis , CVD , and cancer ) and causes of death with longterm follow-up . The ultimate goal of the KoGES was to develop comprehensive and applicable health care guidelines for common complex diseases in Koreans , reduce the burden of chronic diseases and improve the quality of life 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 Type 2 diabetes is a global public health crisis that threatens the economies of all nations , particularly developing countries . Fueled by rapid urbanization , nutrition transition , and increasingly sedentary lifestyles , the epidemic has grown in parallel with the worldwide rise in obesity . Asia 's large population and rapid economic development have made it an epicenter of the epidemic . Asian population s tend to develop diabetes at younger ages and lower BMI levels than Caucasians . Several factors contribute to accelerated diabetes epidemic in Asians , including the “ normal-weight metabolically obese ” phenotype ; high prevalence of smoking and heavy alcohol use ; high intake of refined carbohydrates ( e.g. , white rice ) ; and dramatically decreased physical activity levels . Poor nutrition in utero and in early life combined with overnutrition in later life may also play a role in Asia 's diabetes epidemic . Recent advances in genome-wide association studies have contributed substantially to our underst and ing of diabetes pathophysiology , but currently identified genetic loci are insufficient to explain ethnic differences in diabetes risk . Nonetheless , interactions between Westernized diet and lifestyle and genetic background may accelerate the growth of diabetes in the context of rapid nutrition transition . Epidemiologic studies and r and omized clinical trials show that type 2 diabetes is largely preventable through diet and lifestyle modifications . Translating these findings into practice , however , requires fundamental changes in public policies , the food and built environments , and health systems . To curb the escalating diabetes epidemic , primary prevention through promotion of a healthy diet and lifestyle should be a global public policy priority Background Cardiovascular disease and type 2 diabetes are examples of chronic diseases that impose significant morbidity and mortality in the general population worldwide . Most chronic diseases are associated with underlying preventable risk factors , such as elevated blood pressure , high blood glucose or glucose intolerance , high lipid levels , physical inactivity , excessive sedentary behaviours , and overweight/obesity . The occurrence of intermediate outcomes during childhood increases the risk of disease in adulthood . Sugar-sweetened beverages are known to be significant sources of additional caloric intake , and given recent attention to their contribution in the development of chronic diseases , a systematic review is warranted . We will assess whether the consumption of sugar-sweetened beverages in children is associated with adverse health outcomes and what the potential moderating factors are . Methods / Design Of interest are studies addressing sugar-sweetened beverage consumption , taking a broad perspective . Both direct consumption studies as well as those evaluating interventions that influence consumption ( e.g. school policy , educational ) will be relevant . Non-specific or multi-faceted behavioural , educational , or policy interventions may also be included subject to the level of evidence that exists for the other interventions /exposures . Comparisons of interest and endpoints of interest are pre-specified . We will include r and omized controlled trials , controlled clinical trials , interrupted time series studies , controlled before-after studies , prospect i ve and retrospective comparative cohort studies , case – control studies , and nested case – control design s. The MEDLINE ® , Embase , The Cochrane Library , CINAHL , ERIC , and PsycINFO ® data bases and grey literature sources will be search ed . The processes for selecting studies , abstract ing data , and resolving conflicts are described . We will assess risk of bias using design -specific tools . To determine sets of confounding variables that should be adjusted for , we have developed causal directed acyclic graphs and will use those to inform our risk of bias assessment s. Meta- analysis will be conducted where appropriate ; parameters for exploring statistical heterogeneity and effect modifiers are pre-specified . The Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach will be used to determine the quality of evidence for outcomes . Systematic review registration PROSPERO CRD42014009641 Background The future risk of heart disease can be predicted with increasing precision . However , more research is needed into how this risk is conveyed and presented . The aim of this study is to compare the effects of presenting cardiovascular risk in different formats on individuals ' intention to change behaviour to reduce risk , underst and ing of risk information and emotional affect . Methods / design A r and omised controlled trial comprising four arms , with a between subjects design will be performed . There will be two intervention groups and two control groups . The first control comprises a pre-intervention question naire and presents risk in a bar graph format . The second control presents risk in a bar graph format without pre-intervention question naire . These two control groups are to account for the potential Hawthorne effect of thinking about cardiovascular risk before viewing actual risk . The two intervention groups comprise presenting risk in either a pictogram or metonym format ( image depicting seriousness of having a myocardial infa rct ion ) .  800 individuals ' aged between 45 and 64 years , who have not been previously diagnosed with heart disease and have access to a computer with internet , will be given a link to a website comprising a risk calculator and electronic question naires . 10-year risk of having a coronary heart disease event will be assessed and presented in one of the three formats . A post-intervention question naire will be completed after viewing the risk format . Main outcome measures are ( i ) intention to change behaviour , ( ii ) underst and ing of risk information , ( iii ) emotional affect and ( iv ) worry about future heart disease . Secondary outcomes are the sub-components of the theory of planned behaviour : attitudes , perceived behavioural control and subjective norms . Discussion Having review ed the literature , we are not aware of any other studies which have used the assessment of actual risk , in a trial to compare different graphical cardiovascular risk presentation formats . This trial will provide data about which graphical cardiovascular risk presentation format is most effective in encouraging behaviour change to reduce cardiovascular risk . Trial registration Current Controlled Trials IS RCT UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT Family history represents the integration of risk within a family from shared genetic susceptibilities and familial clustering of environmental exposures , lifestyles , and behaviors . Epidemiologic evidence shows associations between family history and risk for many common chronic diseases ( 17 ) . Thus , family history information might aid in assessing risk for a condition , even in the absence of an underst and ing of the molecular cause of that condition and even for disorders that do not follow a distinct Mendelian inheritance pattern . Knowledge of family history might also act as a motivator for behavior change ( 8) . As with any health care intervention , family historybased risk assessment carries re source implication s and opportunity costs . We present evidence about the potential beneficial and harmful effects of collecting and using family history information , family history elements that are most useful for risk assessment , and the accuracy of family history information reported by patients . We focus on family history collection and interpretation in a primary care context , in which the population presents a full range of disease risks , primary care practitioners obtain history information , and chronic disease risk assessment and prevention is the goal . Methods We developed and followed a st and ard protocol for all steps of the review . A technical report that details methods , including the literature search strategies , and presents results for 6 original research questions is available at www.ahrq.gov . The Appendix and Appendix Figure , provide further details of our methods and analytic framework . Appendix . Appendix Material s Key Questions This evidence review addresses 4 of 6 original research questions developed by a panel from the National Human Genome Research Institute and the Office of Medical Applications of Research of the National Institutes of Health . A representative from the panel and the Technical Expert Panel helped refine the scope of the questions and define pertinent eligibility criteria . They recommended focusing on primary care and selecting experimental and quasi-experimental design s for the effectiveness questions . 1 . What is the direct evidence that getting a family history will improve health outcomes for the patient or family ? 2 . What is the direct evidence that getting a family history will result in adverse outcomes for the patient or family ? 3 . What are the key elements of a family history in a primary care setting for the purpose s of risk assessment for common diseases ? 4 . What is the accuracy of family history , and under what conditions does the accuracy vary ? Data Sources and Selection We search ed for English- language publications in MEDLINE , EMBASE , CINAHL , the Cochrane Central Registry of Controlled Trials , and PsycINFO from 1995 to 2 March 2009 . With the exception of question 4 , we restricted participants to those who were unselected for high preexisting risk and recruited from general population setting s. We excluded studies of patients undergoing genetic testing because of suspicion of high a priori risk . We defined the intervention as the systematic collection of family history by any means , alone or with other risk information . For questions 1 and 2 , we restricted study design s to r and omized , controlled trials ; nonr and omized trials ; and beforeafter studies . For question 3 , we restricted design s to retrospective and prospect i ve cohort studies and cross-sectional studies and the conditions of interest to breast , colorectal , ovarian , prostate , and lung cancer ; coronary heart disease ; stroke ; and diabetes . For question 4 , we did not restrict study design . The eligible outcomes varied with the research questions . ( Full technical report is available at www.ahrq.gov . ) Trained research assistants independently screened each citation using st and ardized forms and a training manual developed by the review ers . They assessed eligibility on the basis of title and abstract and retrieved articles if at least 1 judged it potentially eligible . At full-text screening , 2 assistants came to consensus on the identification , selection , and data abstract ion . We review ed all reports with unclear eligibility and resolved any disagreements about selection or data by discussion . Data Extraction and Quality Assessment We extracted data on participant characteristics , method of family history collection , study outcomes , study design , and quality . At least 1 review er confirmed all data extraction . We assessed quality on the basis of r and omization , blinding processes , and completeness of follow-up for controlled trials ( 9 ) ; risk for selection and outcome biases for uncontrolled beforeafter studies ; selection and information biases for longitudinal and cross-sectional analyses relevant to question 3 ; and spectrum , selection , verification , and masking biases for studies relevant to question 4 ( 10 ) . For question 4 , we treated patient reporting of family history as the index test and the verified disease status of the relatives as the reference test ; we assumed that both the index test and the reference test were equivalent across studies . Data Synthesis and Analysis We used a descriptive approach to summarize study characteristics and outcomes for all research questions . For question 3 , we compared the predictive accuracy of family history elements by first considering specific ancestry , specific relative of interest ( for example , mother ) , degree of relative of interest 's relationship to informant ( for example , first degree ) , age of onset of condition in affected relative , and lineage of affected relative ( informant 's maternal or paternal line ) to be categories of family history elements . We then treated any definition of positive family history reported in an article as a combination of these elements . For each report , we noted the elements each definition incorporated . We then calculated the sensitivity and specificity of each definition for predicting or detecting the disease of interest , treating fulfillment of the definition as the test and nonfulfillment as the reference . For each condition , we compared the sensitivities and specificities for each definition ( each combination of 1 or more elements ) . We decided that meta- analysis was inappropriate because of an insufficient number of studies and data for questions 1 and 2 ; important clinical heterogeneity across studies and nonindependence of many observations for question 3 ; and important clinical heterogeneity across studies , insufficient studies for some disease categories , and missing measures of variance for evidence relevant to question 4 . Role of the Funding Source The Agency for Healthcare Research and Quality , in partnership with the National Institutes of Health Office of Medical Applications of Research Consensus Conferences , suggested the initial questions . The Agency for Healthcare Research and Quality provided copyright release for this manuscript . Both the Agency for Healthcare Research and Quality and the National Institutes of Health Office of Medical Applications of Research representatives were informed of key method ological decisions but did not participate in the literature search , data analysis , or interpretation of the results . Results We screened 32444 titles and abstract s and evaluated 1254 full-text articles . A total of 137 publications met eligibility criteria ( Appendix Figure ) . The Table ( 1179 ) summarizes the review ed studies . Table . Summary of Review ed Studies Evidence That Getting a Family History Improves Outcomes We identified 2 uncontrolled beforeafter studies ( 11 , 12 ) that evaluated the effect of collecting family history of breast or ovarian cancer with risk personalization on adherence with recommended breast cancer screening behaviors ( Appendix Tables 1 and 2 ) . One study was  workplace-based  ( 11 ) , and the other recruited walk-in clients of community pharmacies and health fair participants ( 12 ) . The intervention was telephone-based in 1 study and in-person in the other . The outcomes for both studies were self-reported rates of breast self-examination , clinical breast examination , and screening mammography at 8 ( 11 ) or 6 ( 12 ) months . Both studies showed an increase in breast self-examination rates , from 34 % to 62 % ( 11 ) and 31 % to 56 % ( 12 ) , and an increase in clinical breast examination rates , from 82 % to 92 % ( P < 0.014 ) ( 11 ) and 86 % to 91 % ( P < 0.090 ) ( 12 ) . One study showed an increase in mammography uptake from 76 % to 93 % ( P < 0.057 ) ( 11 ) , and the other showed a decrease from 75 % to 70 % ( P < 0.48 ) ( 12 ) . These 2 studies provide limited and insufficient evidence about the effect of collecting family history and personalizing risk on health behavior . They had low statistical power , lacked control groups , and had concurrent co- interventions such as awareness campaignsthat probably affected results . Also , study participants were from self-selected groups who had relatively high baseline rates of adherence to screening recommendations . Evidence That Getting a Family History Causes Harm We identified 1 r and omized , controlled trial ( 13 ) , with 100 r and omly assigned and 76 analyzed participants , and 2 uncontrolled beforeafter studies ( 14 , 15 ) ( Appendix Tables 3 and 4 ) . Two studies ( 13 , 15 ) evaluated  generic family history assessment  , and 1 ( 14 ) specifically evaluated  cancer history assessment . One study evaluated family history as part of a periodic health examination ( 13 ) , the second within a dedicated family practice clinic ( 15 ) , and the third through a special postal survey ( 14 ) . Personalized risk was provided in person in 2 studies ( 13 , 15 ) and by letter ( low-risk respondents ) or in person ( high-risk respondents ) in the third ( 14 ) . Anxiety and cancer worry were the reported outcomes . All 3 studies assessed anxiety by using the short form Spielberger State-Trait Anxiety Inventory ( 80 ) . The r and omized , controlled trial ( 13 ) observed an increase in anxiety scores in the intervention group compared with the control group at 1 and 2 Background Combined lifestyle interventions ( CLIs ) have been advocated as an effective instrument in efforts to reduce overweight and obesity . The odds of maintaining higher levels of  physical activity ( PA ) and healthier dietary behaviour improve when people are more intrinsically motivated to change their behaviour . To promote the shift towards more autonomous types of motivation , facilitator led CLIs have been developed including lifestyle coaching as key element . The present study examined the shift in types of motivation to increase  PA  and  healthy dieting  among participants of a primary care CLI , and the contribution of lifestyle coaching to potential changes in motivational quality . Methods This prospect i ve cohort study included participants of 29 general practice s in the Netherl and s that implemented a CLI named ‘ BeweegKuur ’ .  Question naires including items on demographics , lifestyle coaching and motivation were sent at baseline and after 4 months . Aspects of motivation were assessed with the  Behavioural Regulation and Exercise Question naire ( BREQ-2 ) and the  Regulation of Eating Behaviour Question  naire ( REBS ) . We performed a drop out analysis to identify selective drop-out . Changes in motivation were analysed with t-tests and effect size interpretations ( Cohen ’s d ) , and multivariate regression analysis was used to identify predictors of motivational change . Results For physical activity , changes in motivational regulation were fully in line with the tenets of Self Determination Theory and Motivational Interviewing : participants made a shift towards a more autonomous type of motivation ( i.e. controlled types of motivation decreased and autonomous types increased ) . Moreover , an autonomy supportive coaching style was generally found to predict a larger shift in autonomous types of motivation . For healthy dietary behaviour , however , except for a small decrease in external motivation , no favourable changes in different types of motivation were observed . The relation between coaching and motivation appeared to be influenced by the presence of physical activity guidance in the programme . Conclusions Motivation of participants of a real life primary care CLI had changed towards a more autonomous motivation after 4 months of intervention . Autonomy-supportive lifestyle coaching contributed to this change with respect to physical activity . Lifestyle coaching for healthy diet requires thorough knowledge about the problem of unhealthy dieting and solid coaching skills
This review found no clear or consistent evidence that genetic risk communication alone either raises motivation or translates into actual change in dietary intake or physical activity to reduce the risk of cardiometabolic disorders in adults .
Genetic risk prediction of chronic conditions including obesity , diabetes and CVD currently has limited predictive power but its potential to engage healthy behaviour change has been of immense research interest .
We aim ed to underst and whether the latter is indeed true by conducting a systematic review and meta- analysis investigating whether genetic risk communication affects motivation and actual behaviour change towards preventative lifestyle modification .