Validation of Urinary Thiocyanate as a Robust Biomarker of Active Tobacco Smoking in the Prospective Urban and Rural Epidemiological Study.

INTRODUCTION: Tobacco smoking is a leading preventable cause of premature death globally. Urinary thiocyanate is a biomarker of cyanide exposure from tobacco smoke; however, few studies have evaluated its utility in diverse populations of smokers. AIMS AND METHODS: We examined the associations between urinary thiocyanate and self-reported never and current smokers among 1000 participants from 14 countries in the Prospective Urban and Rural Epidemiological study. We analyzed urinary thiocyanate in light and heavy smokers as compared to never-smokers from high- (HICs), middle- (MICs), and low-income countries (LICs) using a validated capillary electrophoresis method in conjunction with standardized questionnaires. RESULTS: The median urinary thiocyanate concentration was 31 µM, which ranged from 8.6 µM to 52 µM for never-smokers (n = 335) and current smokers (n = 660), respectively. Urinary thiocyanate was correlated with daily cigarette consumption (r = 0.621) and total nicotine equivalents (r = 0.514). Thiocyanate also displayed a better dose-response than urinary cotinine. A moderate association of urinary thiocyanate was found in biochemically verified never-smokers (r ~0.38) because of intake of vegetables, fruits, and dairy. Receiver-operating characteristic curves established cutoff values for urinary thiocyanate to differentiate current from never-smokers with an optimal threshold of 23.9 µM (Area Under the Curve or AUC = 0.861), which lowered progressively from HICs, MICs, and LICs. CONCLUSIONS: Elevated thiocyanate was evident in current smokers from high-income countries likely reflecting differences in smoking topography and greater toxicant burden. Background urinary thiocyanate in never-smokers was associated with goitrogenic food intake that obscured detection of secondhand smoke exposure. IMPLICATIONS: Urinary thiocyanate is a sensitive biomarker of active tobacco smoking relative to cotinine that can be measured by an inexpensive capillary electrophoresis assay. Regional cutoff values are demonstrated to improve discrimination of smoking status in developing countries because of differences in smoking habits and cigarette products consumed, as well as intake of goitrogenic foods. Urinary thiocyanate may allow for more reliable estimates of the hazards of tobacco smoking between countries with varying socioeconomic development as compared to self-reports.

A peer support program results in greater health benefits for peer leaders than other participants: evidence from the Kerala diabetes prevention program.

BACKGROUND: Peer support programs are promising approaches to diabetes prevention. However, there is still limited evidence on the health benefits of peer support programs for lay peer leaders. PURPOSE: To examine whether a peer support program designed for diabetes prevention resulted in greater improvements in health behaviors and outcomes for peer leaders as compared to other participants. METHODS: 51 lay peer leaders and 437 participants from the Kerala Diabetes Prevention Program were included. Data were collected at baseline, 12 months, and 24 months. We compared behavioral, clinical, biochemical, and health-related quality of life parameters between peer leaders and their peers at the three time-points. RESULTS: After 12 months, peer leaders showed significant improvements in leisure time physical activity (+ 17.7% vs. + 3.4%, P = 0.001) and health-related quality of life (0.0 vs. + 0.1, P = 0.004); and a significant reduction in alcohol use (-13.6% vs. -6.6%, P = 0.012) and 2-hour plasma glucose (-4.1 vs. + 9.9, P = 0.006), as compared to participants. After 24 months, relative to baseline, peer leaders had significant improvements in fruit and vegetable intake (+ 34.5% vs. + 26.5%, P = 0.017) and leisure time physical activity (+ 7.9% vs. -0.9%, P = 0.009); and a greater reduction in alcohol use (-13.6% vs. -4.9%, P = 0.008), and waist-to-hip ratio (-0.04 vs. -0.02, P = 0.014), as compared to participants. However, only the changes in fruit and vegetable intake and waist-to-hip ratio were maintained between 12 and 24 months. CONCLUSION: Being a peer leader in a diabetes prevention program was associated with greater health benefits during and after the intervention period. Further studies are needed to examine the long-term sustainability of these benefits.

The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol.

INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Effects of a lifestyle intervention on depression and anxiety among adults at risk for diabetes in India: A secondary analysis of the Kerala Diabetes Prevention Program.

The impact of lifestyle interventions on diabetes and mental health conditions have been documented among people with diabetes. However, the mental health benefits of lifestyle interventions designed for diabetes prevention have not been systematically investigated among people at high risk of diabetes, particularly in low- and middle-income countries. We examined the effects of a 12-month peer support lifestyle intervention designed for diabetes prevention on depression and anxiety symptomology in the sample population of the Kerala Diabetes Prevention Program. Mixed-effects linear regression models were used to examine the effect of the intervention on depression and anxiety scores at 12 and 24 months in the total sample of 1007 adults at risk for diabetes and among those with mild-severe depressive or anxiety symptoms at baseline (n = 326 for depression; n = 203 for anxiety). Among all participants, the intervention group had a significantly higher reduction of depressive symptoms as compared to the control group at 12 months (mean diff score = -0.51; 95% CI: -0.95, -0.07; P = 0.02). This effect was not sustained at 24 months. There were no significant intervention effects for anxiety. Among those with mild-severe symptoms at baseline, the intervention group had a significantly higher reduction of depressive symptoms (mean diff score = -1.55; 95% CI -2.50, -0.6; P = 0.001) and anxiety symptoms (mean diff score = -1.64; 95% CI -2.76, -0.52; P = 0.004) at 12 months. The effect was sustained at 24 months for depression, but not anxiety. Lifestyle interventions designed for prevention of diabetes might improve depressive and anxiety symptoms in the short-term, particularly among those with mild-severe symptoms.

Associations between attainment of incentivised primary care indicators and incident diabetic retinopathy in England: a population-based historical cohort study.

BACKGROUND: The associations between England's incentivised primary care-based diabetes prevention activities and hard clinical endpoints remain unclear. We aimed to examine the associations between attainment of primary care indicators and incident diabetic retinopathy (DR) among people with type 2 diabetes. METHODS: A historical cohort (n = 60,094) of people aged ≥ 18 years with type 2 diabetes and no DR at baseline was obtained from the UK Clinical Practice Research Datalink (CPRD). Exposures included attainment of the Quality and Outcomes Framework (QOF) HbA1c (≤ 7.5% or 59 mmol/mol), blood pressure (≤ 140/80 mmHg), and cholesterol (≤ 5 mmol/L) indicators, and number of National Diabetes Audit (NDA) care processes completed (categorised as 0-3, 4-6, or 7-9), in 2010-2011. Outcomes were time to development of DR and sight-threatening diabetic retinopathy (STDR). Nearest neighbour propensity score matching was undertaken and Cox proportional hazards models then fitted using the matched samples. Concordance statistics were calculated for each model. RESULTS: 8263 DR and 832 STDR diagnoses were observed over mean follow-up periods of 3.5 (SD 2.1) and 3.8 (SD 2.0) years, respectively. HbA1c and blood pressure (BP) indicator attainment were associated with lower rates of DR (adjusted hazard ratios (aHRs) 0.94 (95% CI 0.89-0.99) and 0.87 (0.83-0.92), respectively), whereas cholesterol indicator attainment was not (aHR 1.03 (0.97-1.10)). All QOF indicators were associated with lower rates of STDR (aHRs 0.74 (0.62-0.87) for HbA1c, 0.78 (0.67-0.91) for BP, and 0.82 (0.67-0.99) for cholesterol). Completion of 7-9 vs. 0-3 NDA processes was associated with fewer STDR diagnoses (aHR 0.72 (0.55-0.94)). CONCLUSIONS: Attainment of key primary care indicators is associated with lower incidence of DR and STDR among patients with type 2 diabetes in England.

Associations between attainment of incentivized primary care indicators and incident sight-threatening diabetic retinopathy in England: A population-based historical cohort study.

AIM: To examine the impact of attainment of primary care diabetes clinical indicators on progression to sight-threatening diabetic retinopathy (STDR) among those with mild non-proliferative diabetic retinopathy (NPDR). MATERIALS AND METHODS: An historical cohort study of 18,978 adults (43.63% female) diagnosed with type 2 diabetes before 1 April 2010 and mild NPDR before 1 April 2011 was conducted. The data were obtained from the UK Clinical Practice Research Datalink during 2010-2017, provided by 330 primary care practices in England. Exposures included attainment of the Quality and Outcomes Framework HbA1c (≤59 mmol/mol [≤7.5%]), blood pressure (≤140/80 mmHg) and cholesterol (≤5 mmol/L) indicators in the financial year 2010-2011, as well as the number of National Diabetes Audit processes completed in 2010-2011. The outcome was time to incident STDR. Nearest neighbour propensity score matching was undertaken, and univariable and multivariable Cox proportional hazards models were then fitted using the matched samples. Concordance statistics were calculated for each model. RESULTS: A total of 1037 (5.5%) STDR diagnoses were observed over a mean follow-up of 3.6 (SD 2.0) years. HbA1c, blood pressure and cholesterol indicator attainment were associated with lower rates of STDR (adjusted hazard ratios [95% CI] 0.64 [0.55-0.74; p < .001], 0.83 [0.72-0.94; p = .005] and 0.80 [0.66-0.96; p = .015], respectively). CONCLUSIONS: Our findings provide support for meeting appropriate indicators for the management of type 2 diabetes in primary care to bring a range of benefits, including improved health outcomes-such as a reduction in the risk of STDR-for people with type 2 diabetes.

Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial.

BACKGROUND: New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS: We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS: While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION: The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Cost-effectiveness of a lifestyle intervention in high-risk individuals for diabetes in a low- and middle-income setting: Trial-based analysis of the Kerala Diabetes Prevention Program.

BACKGROUND: Data on the cost-effectiveness of lifestyle-based diabetes prevention programs are mostly from high-income countries, which cannot be extrapolated to low- and middle-income countries. We performed a trial-based cost-effectiveness analysis of a lifestyle intervention targeted at preventing diabetes in India. METHODS: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial of 1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state. Participants (30-60 years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test. The intervention group received a 12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders. There were also linked community activities to sustain behavior change. The control group received a booklet on lifestyle change. Costs were estimated from the health system and societal perspectives, with 2018 as the reference year. Effectiveness was measured in terms of the number of diabetes cases prevented and quality-adjusted life years (QALYs). Three times India's gross domestic product per capita (US$6108) was used as the cost-effectiveness threshold. The analyses were conducted with a 2-year time horizon. Costs and effects were discounted at 3% per annum. One-way and multi-way sensitivity analyses were performed. RESULTS: Baseline characteristics were similar in the two study groups. Over 2 years, the intervention resulted in an incremental health system cost of US$2.0 (intervention group: US$303.6; control group: US$301.6), incremental societal cost of US$6.2 (intervention group: US$367.8; control group: US$361.5), absolute risk reduction of 2.1%, and incremental QALYs of 0.04 per person. From a health system perspective, the cost per diabetes case prevented was US$95.2, and the cost per QALY gained was US$50.0. From a societal perspective, the corresponding figures were US$295.1 and US$155.0. For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively. The corresponding figures for QALY gained were 99.1% and 97.8%. The results were robust to discounting and sensitivity analyses. CONCLUSIONS: A community-based peer-support lifestyle intervention was cost-effective in individuals at high risk of developing diabetes in India over 2 years. TRIAL REGISTRATION: The trial was registered with Australia and New Zealand Clinical Trials Registry ( ACTRN12611000262909 ). Registered 10 March 2011.

Effects of a lifestyle intervention on cardiovascular risk among high-risk individuals for diabetes in a low- and middle-income setting: Secondary analysis of the Kerala Diabetes Prevention Program.

We aimed to examine whether a lifestyle intervention was effective in reducing cardiovascular disease (CVD) risk in individuals at high-risk of developing diabetes in a low- and middle-income setting. The Kerala Diabetes Prevention Program was evaluated by a cluster-randomized controlled trial (2013-2016) of 1007 individuals (aged 30-60 years) at high-risk for diabetes (Indian Diabetes Risk Score ≥ 60 and without diabetes) in Kerala state, India. Sixty polling areas in Kerala were randomized to intervention or control groups by an independent statistician using a computer-generated randomization sequence. Participants from 30 intervention communities received a 12-month structured peer-support lifestyle intervention program involving 15 group sessions and linked community activities, aimed at supporting and maintaining lifestyle change. The primary outcome for this analysis was the predicted 10-year CVD risk at two years, assessed using the Framingham Risk Score. The mean age at baseline was 46.0 (SD: 7.5) years, and 47.2% were women. Baseline 10-year CVD risk was similar between study groups. The follow-up rate at two years was 95.7%. The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years. The favorable change in CVD risk with the intervention condition was mainly due to the reduction in tobacco use (change index: -0.25, 95% CI: -0.42 to -0.09). Our findings suggest that a community-based peer-support lifestyle intervention could reduce CVD risk in individuals at high-risk of developing diabetes in India. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.

A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program.

BACKGROUND: The major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score. METHODS AND FINDINGS: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) ≥60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate. CONCLUSIONS: A low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.

Health trends in Canada 1990-2019: An analysis for the Global Burden of Disease Study.

OBJECTIVE: Monitoring trends in key population health indicators is important for informing health policies. The aim of this study was to examine population health trends in Canada over the past 30 years in relation to other countries. METHODS: We used data on disability-adjusted life years (DALYs), years of life lost (YLL), years lived with disability, life expectancy (LE), and child mortality for Canada and other countries between 1990 and 2019 provided by the Global Burden of Disease Study. RESULTS: Life expectancy, age-standardized YLL, and age-standardized DALYs all improved in Canada between 1990 and 2019, although the rate of improvement has leveled off since 2011. The top five causes of all-age DALYs in Canada in 2019 were neoplasms, cardiovascular diseases, musculoskeletal disorders, neurological disorders, and mental disorders. The greatest increases in all-age DALYs since 1990 were observed for substance use, diabetes and chronic kidney disease, and sense organ disorders. Age-standardized DALYs declined for most conditions, except for substance use, diabetes and chronic kidney disease, and musculoskeletal disorders, which increased by 94.6%, 14.6%, and 7.3% respectively since 1990. Canada's world ranking for age-standardized DALYs declined from 9th place in 1990 to 24th in 2019. CONCLUSION: Canadians are healthier today than in 1990, but progress has slowed in Canada in recent years in comparison with other high-income countries. The growing burden of substance abuse, diabetes/chronic kidney disease, and musculoskeletal diseases will require continued action to improve population health.

RéSUMé: OBJECTIF: La surveillance des tendances des indicateurs clés de la santé de la population est importante pour éclairer les politiques de santé. Dans cette étude, nous avons examiné les tendances de la santé de la population au Canada au cours des 30 dernières années par rapport à d'autres pays. MéTHODES: Nous avons utilisé des données sur les années de vie ajustées en fonction de l'incapacité (DALY), les années de vie perdues (YLL), les années vécues avec un handicap, l'espérance de vie (LE) et la mortalité infantile pour le Canada et d'autres pays entre 1990 et 2019, fournies par l'Étude mondiale sur le fardeau de la maladie. RéSULTATS: L'espérance de vie, les YLL ajustées selon l'âge et les DALY ajustées selon l'âge ont tous connu une amélioration au Canada entre 1990 et 2019, bien que le taux d'amélioration se soit stabilisé depuis 2011. Les cinq principales causes des DALY pour tous les âges au Canada en 2019 étaient les néoplasmes, les maladies cardiovasculaires, les affections musculosquelettiques, les affections neurologiques et les troubles mentaux. Les plus fortes augmentations des DALY pour tous les âges depuis 1990 ont été observées pour l'usage de substances, le diabète et les maladies rénales chroniques, ainsi que les troubles des organes sensoriels. Les DALY ajustées selon l'âge ont diminué pour la plupart des conditions, à l'exception de l'usage de substances, du diabète et des maladies rénales chroniques, ainsi que des troubles musculosquelettiques, qui ont augmenté de 94,6 %, 14,6 % et 7,3 % respectivement depuis 1990. Le classement mondial du Canada pour les DALY ajustées selon l'âge est diminué de la 9ième place en 1990 à la 24ième place en 2019. CONCLUSION: Les Canadiens sont en meilleure santé aujourd'hui qu'en 1990, mais les progrès se sont ralentis ces dernières années par rapport à d'autres pays à revenu élevé. La croissance du fardeau lié à l'abus de substances, au diabète/maladies rénales chroniques et aux affections musculosquelettiques exigera des actions continues pour améliorer la santé de la population.

Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) has become a major public health challenge in India. Factors relevant to the development and implementation of diabetes prevention programmes in resource-constrained countries, such as India, have been under-studied. The purpose of this study is to describe the findings from research aimed at informing the development and evaluation of a Diabetes Prevention Programme in Kerala, India (K-DPP). METHODS: Data were collected from three main sources: (1) a systematic review of key research literature; (2) a review of relevant policy documents; and (3) focus groups conducted among individuals with a high risk of progressing to diabetes. The key findings were then triangulated and synthesised. RESULTS: Prevalence of risk factors for diabetes is very high and increasing in Kerala. This situation is largely attributable to rapid changes in the lifestyle of people living in this state of India. The findings from the systematic review and focus groups identified many environmental and personal determinants of these unhealthy lifestyle changes, including: less than ideal accessibility to and availability of health services; cultural values and norms; optimistic bias and other misconceptions related to risk; and low expectations regarding one's ability to make lifestyle changes in order to influence health and disease outcomes. On the other hand, there are existing intervention trials conducted in India which suggests that risk reduction is possible. These programmes utilize multi-level strategies including mass media, as well as strategies to enhance community and individual empowerment. India's national programme for the prevention and control of major non-communicable diseases (NCD) also provide a supportive environment for further community-based efforts to prevent diabetes. CONCLUSION: These findings provide strong support for undertaking more research into the conduct of community-based diabetes prevention in the rural areas of Kerala. We aim to develop, implement and evaluate a group-based peer support programme that will address cultural and family determinants of lifestyle risks, including family decision-making regarding adoption of healthy dietary and physical activity patterns. Furthermore, we believe that this approach will be feasible, acceptable and effective in these communities; with the potential for scale-up in other parts of India.

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.

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 resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. METHODS/DESIGN: A total of 60 polling booths are randomised 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 questionnaire. 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 questionnaires, undergo physical measurements, and provide blood samples 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 handbook 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 assessments 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 resource-constrained settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

Screening performance of diabetes risk scores among Asians and whites in rural Kerala, India.

We compared the screening performance of risk scores for Asians and whites for diabetes, dysglycemia, and metabolic syndrome. Our subjects were 451 people aged 15 to 64 years who participated in a cohort study from May 2003 through September 2010 in a rural area of the Thiruvananthapuram district of Kerala, India. All outcome measures showed overlap in the range of area under the receiver operating characteristic curves of Asian and white diabetes risk scores (DRSs). Asian and white DRSs performed similarly in rural India.

Development of a Modified Global Physical Activity Questionnaire and Its Construct Validity among Adults in Kerala, India.

There is a need for a modified Global Physical Activity Questionnaire (GPAQ) to estimate physical activity levels more accurately in populations. We aimed to develop a modified GPAQ and examine its construct validity among adults in Kerala, India. We incorporated locality-specific, metabolic equivalent task (MET)-based activities into the original GPAQ and administered this modified GPAQ among randomly selected 451 individuals (age ≥ 20 years) residing in the Trivandrum district of Kerala. Construct validity of the modified GPAQ was assessed using generalized linear models by examining the association of total moderate-to-vigorous physical activity (MVPA) MET-minutes per week with clinical measures. The mean age of participants was 45.4 (SD: 14.1) years, and 52.6% were female. Increasing total MVPA MET-minutes per week was associated with decreasing weight (ß = -0.011 kg, 95% CI: -0.020, -0.002), waist circumference (ß = -0.013 cm, 95% CI: -0.023, -0.004), and systolic blood pressure (ß = -0.009 mmHg, 95% CI: -0.015, -0.002), independent of age, sex, education, occupation, current smoking, current alcohol use, and fruit and vegetable intake. The validity coefficients and associations between total MVPA MET-minutes per week and theoretical constructs of physical activity agreed with those predicted, providing evidence of construct validity for the modified GPAQ.

Effect of Conventional Lifestyle Interventions on Type 2 Diabetes Incidence by Glucose-Defined Prediabetes Phenotype: An Individual Participant Data Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To examine whether the effect of conventional lifestyle interventions on type 2 diabetes incidence differs by glucose-defined prediabetes phenotype. RESEARCH DESIGN AND METHODS: We searched multiple databases until 1 April 2023 for randomized controlled trials that recruited people with isolated impaired fasting glucose (i-IFG), isolated impaired glucose tolerance (i-IGT), and impaired fasting glucose plus impaired glucose tolerance (IFG+IGT). Individual participant data were pooled from relevant trials and analyzed through random-effects models with use of the within-trial interactions approach. RESULTS: Four trials with 2,794 participants (mean age 53.0 years, 60.7% men) were included: 1,240 (44.4%), 796 (28.5%), and 758 (27.1%) had i-IFG, i-IGT, and IFG+IGT, respectively. After a median of 2.5 years, the pooled hazard ratio for diabetes incidence in i-IFG was 0.97 (95% CI 0.66, 1.44), i-IGT 0.65 (0.44, 0.96), and IFG+IGT 0.51 (0.38, 0.68; Pinteraction = 0.01). CONCLUSIONS: Conventional lifestyle interventions reduced diabetes incidence in people with IGT (with or without IFG) but not in those with i-IFG.

Effectiveness of a School-Based Educational Intervention to Improve Hypertension Control Among Schoolteachers: A Cluster-Randomized Controlled Trial.

Background The control of hypertension is low in low- and middle-income countries like India. We evaluated the effects of a nurse-facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster-randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse-facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed-effects logistic regression models. Two months after a 3-month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06-3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08-2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, -7.2 to -1.1) than in the usual care group. Conclusions A nurse-facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in; Unique Identifier: CTRI/2018/01/011402.

Associations between Dietary Patterns and Cardiometabolic Risk Factors-A Longitudinal Analysis among High-Risk Individuals for Diabetes in Kerala, India.

The association between dietary patterns and cardiometabolic risk factors is not well understood among adults in India, particularly among those at high risk for diabetes. For this study, we analyzed the data of 1007 participants (age 30-60 years) from baseline and year one and two follow-ups from the Kerala Diabetes Prevention Program using multi-level mixed effects modelling. Dietary intake was measured using a quantitative food frequency questionnaire, and dietary patterns were identified using principal component analysis. Two dietary patterns were identified: a "snack-fruit" pattern (highly loaded with fats and oils, snacks, and fruits) and a "rice-meat-refined wheat" pattern (highly loaded with meat, rice, and refined wheat). The "snack-fruit" pattern was associated with increased triglycerides (mg/dL) (ß = 6.76, 95% CI 2.63-10.89), while the "rice-meat-refined wheat" pattern was associated with elevated Hb1Ac (percentage) (ß = 0.04, 95% CI 0.01, 0.07) and central obesity (OR 1.16, 95% CI 1.01, 1.34). These findings may help inform designing dietary interventions for the prevention of diabetes and improving cardiometabolic risk factors in high-diabetes-risk individuals in the Indian setting.