BackgroundThere is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participants aged 5–40 years with risk factors for T2DM.MethodsThis was a randomised controlled trial performed at the National Diabetes Centre, Sri-Lanka. We individually randomised 4672 participants at risk of T2DM, of whom 3539 (mean age 22.5 (range 6–40 years, 48% males) received either trimonthly (P-LSM n = 1726) or 12-monthly (C-LSM n = 1813) peer educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity.ResultsDuring a median follow-up of 3 years, the cumulative incidence of the primary endpoint was n = 479 in P-LSM (74 per 1000 person years) vs. 561 in C-LSM (96 per 1000 person years), with an incident rate ratio (IRR) of 0.89 (95% CI 0.83–0.96, P = 0.02). In post hoc analyses, new onset dysglycaemia (T2DM, IFG and IGT), was the major contributor to the composite and was significantly reduced by P-LSM (IRR 0.9, 95% CI 0.83–0.97, P = 0.01). A significant impact of P-LSM on the incidence of the composite endpoint was noted in 1725 participants (P-LSM n = 850, C-LSM n = 875) aged below 18; P-LSM n = 140 (48 per 1000 person years) versus C-LSM n = 174 (55.4 per 1000 person years), with an IRR of 0.83 (95% CI 0.73–0.94, P = 0.004).ConclusionsIn a young at-risk South-Asian population, a pragmatic LSM programme significantly reduces the incidence of predictors of cardio-metabolic disease. Our results highlight the importance of early intervention in young at-risk subjects.Trial registrationWorld Health Organization international clinical trial registry platform (SLCTR/2008/003). Registration Date: March 28, 2008. Retrospectively registered.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0905-6) contains supplementary material, which is available to authorized users.

BackgroundUrban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years.Methods/DesignThis is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines.DiscussionDIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries.Trial registrationThe trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003

South Asian populations are predisposed to early onset of the metabolic syndrome. Lifestyle intervention programmes have demonstrated a reduction in the metabolic syndrome and CVD risk; however, the most effective components of the multi-faceted lifestyle interventions are unknown. We studied 2637 Sri Lankan males (n 1237) and females (n 1380), with a mean BMI of 23·9 (SD 4·2) kg/m 2 , aged 22·5 (SD 10·0) years, who had participated in a 5-year lifestyle-modification programme to examine the effect of dietary changes on distinct components of the metabolic syndrome. The dietary intervention comprised advice to replace polished starches with unpolished starches, high-fat meat and dairy products with low-fat products and high-sugar beverages and snacks with low-sugar varieties. For the purposes of this analysis, data from the control and intensive lifestyle groups were combined. Anthropometric and biochemical data were recorded, and a FFQ was completed annually. Multiple regression was used to determine the effect of the dietary changes on distinct components of the metabolic syndrome. The ratio unpolished:polished rice was inversely related to change in fasting glucose (β = − 0·084, P = 0·007) and TAG (β = − 0·084, P = 0·005) and positively associated with change in HDL-cholesterol (β = 0·066, P = 0·031) at the 5-year follow-up after controlling for relevant confounders. Red meat intake was positively associated with fasting glucose concentrations (β = 0·05, P = 0·017), whereas low-fat (β = − 0·046, P = 0·018) but not high-fat dairy products (β = 0·003, P = 0·853) was inversely related to glucose tolerance at the follow-up visit. Replacement of polished with unpolished rice may be a particularly effective dietary advice in this and similar populations. The metabolic syndrome (MetS) constitutes a cluster of cardiovascular risk factors, which double the risk for CHD and increase the risk for type 2 diabetes mellitus (T2DM) 5-fold (1) . Although the MetS is a growing epidemic worldwide, the prevalence reaches 25-50 % in some urban areas of South Asia, and the prevalence of individual risk factors is even greater, with obesity and low HDL-cholesterol reaching 68 and 81 %, respectively (2) . These risk factors are also growing in prevalence among children and young adults (2) .The risk of the MetS can be reduced through diet and lifestyle changes (3,4) . In particular, approaches including weight loss (4,5) , increasing whole-grain sources of carbohydrates (6,7) and increasing dairy products intake (8) have a demonstrable effect on components of the MetS. However, the majority of studies on the MetS have been carried out in older, Western populations or Southern Asians who have migrated to Western countries (4)(5)(6)(7)(8)(9) .There are differences in the presentation of the MetS in Southern Asians, who are at higher risk of MetS risk factors such as increased waist circumference (WC) and hyperglycaemia at a given BMI along with lower HDL-cholesterol and higher levels of small, dense LDL-cholesterol compared w...

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The objectives of a stage-matched approach to lifestyle change are that individuals progress forward through the stages of change. It also posits that progression through the stages of change is associated with positive changes in lifestyle behaviours. Measuring the relationship between stage of change and food intake is challenging due to the plurality of dietary behaviours. Furthermore, it is not clear whether changes in behaviour are sustained long-term. In this study we assess the movement through stages of change in the intensive (visits every 3months) and control groups (visits annually) of a large-scale primary prevention study in cardiovascular disease, carried out in 2637 children and young adults in Sri Lanka between 2007 and 2012. We also examine their relationship to dietary behaviours and clinical outcomes. We demonstrate that individuals in both groups continue to progress through stages of change over the course of the study and that measures of dietary behaviours improved from baseline to final follow-up. We also demonstrate that stage of change positively correlates to dietary behaviours including the ratio of recommended:not-recommended items, unpolished:polished starches and low-fat:high-fat food items throughout each year of the study. Finally, participants in the later stages of change at Y2, Y3 and Y4, had a significantly attenuated increase in weight and waist circumference at the final visit in both groups. We therefore demonstrate the usefulness of stage-matched approach in modifying complex dietary behaviours, and that stage of change is a valid measure of dietary behaviours across a large population over time.