Browsing by Author "Sathish, T"
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Item Achutha Menon Centre Diabetes Risk Score: A Type 2 Diabetes Screening Tool for Primary Health Care Providers in Rural India(ASIA-PACIFIC JOURNAL OF PUBLIC HEALTH, 2015) Sathish, T; Kannan, S; Sarma, PS; Thankappan, KRThe authors aimed to develop a diabetes risk score for primary care providers in rural India. They used the baseline data of 451 participants (15-64 years) of a cohort study in a rural area of Kerala, India. The new risk score with age, family history of diabetes, and waist circumference identified 40.8% for confirmatory testing, had a sensitivity of 81.0%, specificity of 68.4%, positive predictive value of 37.0%, and negative predictive value of 94.0% for an optimal cutoff >= 4 with an area under the receiver operating characteristic curve of 0.812 (95% confidence interval = 0.765-0.860). The new risk score with 3 simple, easy-to-measure, less time-consuming, and less expensive variables could be suitable for use in primary care settings of rural India.Item Achutha Menon Centre Diabetes Risk Score: A type 2 diabetes screening tool for primary health care providers in rural India.(Asia Pacific Journal of Public Health, 2015) Sathish, T; Kannan, S; Sarma, PS; Thankappan, KRThe authors aimed to develop a diabetes risk score for primary care providers in rural India. They used the baseline data of 451 participants (15-64 years) of a cohort study in a rural area of Kerala, India. The new risk score with age, family history of diabetes, and waist circumference identified 40.8% for confirmatory testing, had a sensitivity of 81.0%, specificity of 68.4%, positive predictive value of 37.0%, and negative predictive value of 94.0% for an optimal cutoff ?4 with an area under the receiver operating characteristic curve of 0.812 (95% confidence interval = 0.765-0.860). The new risk score with 3 simple, easy-to-measure, less time-consuming, and less expensive variables could be suitable for use in primary care settings of rural India.Item Baseline characteristics of participants in the Kerala Diabetes Prevention Programme: a cluster randomized controlled trial of lifestyle intervention in Asian Indians(Diabetic Medicine, 2016-07) Sathish, T; Oldenburg, B; Tapp, RJ; Shaw, JE; Wolfe, R; Balachandran, S; D’Esposito, F; Absetz, P; Mathews, E; Zimmet, PZ; Thankappan, KRAims To describe the baseline characteristics of participants in the Kerala Diabetes Prevention Program. Methods The Kerala Diabetes Prevention Program is a cluster randomized controlled trial of lifestyle intervention for prevention of Type 2 diabetes mellitus in India. Participants in the study were those aged 30–60 years who had an Indian Diabetes Risk Score ≥ 60 and who were without Type 2 diabetes on oral glucose tolerance test. Data on demographic, lifestyle, clinical and biochemical characteristics were collected using standardized tools. Results A total of 2586 individuals were screened with the Indian Diabetes Risk Score, of these 1529 people (59.1%) had a score ≥ 60, of whom 1209 (79.1%) underwent an oral glucose tolerance test. A total of 202 individuals (16.7%) had undiagnosed Type 2 diabetes and were excluded, and the remaining 1007 individuals were enrolled in the trial (control arm, n = 507; intervention arm, n = 500). The mean participant age was 46.0 ± 7.5 years, and 47.2% were women. The mean Indian Diabetes Risk Score was 67.1 ± 8.4. More than two-thirds (69.0%) had prediabetes and 31.0% had normal glucose tolerance. The prevalence of cardiometabolic risk factors was high, including current tobacco use (34.4% in men), current alcohol use (39.3% in men), no leisure time exercise (98.0%), no daily intake of fruit and vegetables (78.7%), family history of diabetes (47.9%), overweight or obesity (68.5%), hypertension (22.3%) and dyslipidemia (85.4%). Conclusions The Kerala Diabetes Prevention Program recruited participants using a diabetes risk score. A large proportion of the participants had prediabetes and there were high rates of cardiometabolic risk factors. The trial will evaluate the effectiveness of lifestyle intervention in a population selected on the basis of a diabetes risk score.Item Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program(BMC Public Health, 2013) Sathish, T; Williams, ED; Pasricha, N; Absetz, P; Lorgelly, P; Wolfe,R; Mathews,E; Aziz,Z; Thankappan, KR; Zimmet, P; Fisher, E; Tapp, R; Hollingsworth, B; Mahal, A; Shaw, J; Jolley, D; �Daivadanam,�M; Oldenburg BBackground: 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 settingsItem Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol(BMJ OPEN, 2016) Riddell, MA; Joshi, R; Oldenburg, B; Chow, C; Thankappan, KR; Mahal, A; Thomas, N; Srikanth, VK; Evans, RG; Kalyanram, K; Kartik, K; Maulik, PK; Arabshahi, S; Varma, RP; Guggilla, RK; Suresh, O; Mini, GK; D'Esposito, F; Sathish, T; Alim, M; Thrift, AGIntroduction: Hypertension is emerging in rural populations of India. Barriers to diagnosis and treatment of hypertension may differ regionally according to economic development. Our main objectives are to estimate the prevalence, awareness, treatment and control of hypertension in 3 diverse regions of rural India; identify barriers to diagnosis and treatment in each setting and evaluate the feasibility of a community-based intervention to improve control of hypertension. Methods and analysis: This study includes 4 main activities: (1) assessment of risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours in similar to 14 500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an intervention provided by Accredited Social Health Activists (ASHAs), comprising groupbased education and support for individuals with hypertension to self-manage blood pressure. Wards/ villages/hamlets of a larger Mandal are identified as the primary sampling unit (PSU). PSUs are then randomly selected for inclusion in the cross-sectional survey, with further randomisation to intervention or control. Changes in knowledge of hypertension and risk factors, and clinical and anthropometric measures, are assessed. Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs. Ethics and dissemination: Approval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health and Family Welfare (India), institutional review boards at each site and Monash University. In addition to publication in peer-reviewed articles, results will be shared with federal, state and local government health officers, local healthcare providers and communities.Item . A group-based lifestyle intervention for diabetes prevention in low- and middleincome country: implementation evaluation of the Kerala Diabetes Prevention Program(Implementation Science, 2018-07) Aziz, Z; Mathews, E; Absetz, P; Sathish, T; Oldroyd, J; Balachandran, S; Shetty, SS; Thankappan, KR; Oldenburg, BBackground While several efficacy trials have demonstrated diabetes risk reduction through targeting key lifestyle behaviours, there is a significant evidence gap in relation to the successful implementation of such interventions in low- and middle-income countries (LMICs). This paper evaluates the implementation of a cluster randomised controlled trial of a group-based lifestyle intervention among individuals at high-risk of developing type 2 diabetes mellitus (T2DM) in the state of Kerala, India. Our aim is to uncover provider-, participant- and community-level factors salient to successful implementation and transferable to other LMICs. Methods The 12-month intervention program consisted of (1) a group-based peer-support program consisting of 15 sessions over a period of 12 months for high-risk individuals, (2) peer leader (PL) training and ongoing support for intervention delivery, (3) diabetes education resource materials and (4) strategies to stimulate broader community engagement. The evaluation was informed by the RE-AIM and PIPE frameworks. Results Provider-level factors: Twenty-nine (29/30, 97%) intervention groups organised all 15 sessions. A 2-day PL training was attended by 51(85%) of 60 PLs. The PL handbook was found to be ‘very useful’ by 78% of PLs. Participant-level factors: Of 1327 eligible individuals, 1007(76%) participants were enrolled. On average, participants attended eight sessions. Sixty-eight percent rated their interest in group sessions as ‘very interested’, and 55% found the group sessions ‘very useful’ in making lifestyle changes. Inconvenient time (43%) and location (21%) were found to be important barriers for participants who did not attend any sessions. Community-level factors: Community-based activities reached to 41% of the participants for walking groups, 40% for kitchen garden training, and 31% for yoga training. PLs were readily available for support outside the sessions, as 75% of participants reported extracurricular contacts with their PLs. The commitment from the local partner institute and political leaders facilitated the high uptake of the program. Conclusion A comprehensive evaluation of program implementation from the provider-, participant- and community-level perspectives demonstrates that the K-DPP program was feasible and acceptable in changing lifestyle behaviours in high-risk individuals. The findings from this evaluation will guide the future delivery of structured lifestyle modification diabetes programs in LMICs.Item Identifying people at high risk for type 2 diabetes: preliminary results from the Kerala Diabetes Prevention Programme(DIABETOLOGIA, 2015) Oldenburg, B; Sathish, T; Thankappan, KR; Balachandran, S; D'esposito, F; Mathews, E; Lorgelly, P; Absetz, P; Zimmet, PZ; Shaw, J; Tapp, RJItem Incidence of hypertension and its risk factors in rural Kerala, India: a community-based cohort study(Public Health, 2012) Sathish, T; Kannan, S; Sarma, PS; Razum, O; Thankappan, KROBJECTIVES:To investigate the incidence of hypertension and its risk factors in Kerala, India where the epidemiological transition is more advanced than elsewhere in India.STUDY DESIGN: Prospective cohort study. METHODS: A sample of 297 individuals (aged 15-64 years) in rural Kerala, India, who were free of hypertension at study enrolment, were followed-up from 2003 to 2010. At enrolment, demographic characteristics and behavioural risk factors were determined by interview, and the participants underwent physical (blood pressure, height, weight and waist circumference) and biochemical examinations (fasting plasma glucose and serum lipids). At follow-up, blood pressure readings were repeated using the original tool following the same protocol.RESULTS: Nearly one-quarter (23.6%) of the sample developed hypertension over a mean follow-up period of 7.1 (standard deviation 0.2) years. Age ?35 years [relative risk (RR) 4.00, 95% confidence interval (CI) 2.37-6.03], current smoking [RR 1.99, 95% CI 1.14-2.97, population-attributable risk percent (PAR%) 13.3%], high-normal blood pressure (RR 3.53 vs optimal blood pressure, 95% CI 2.17-5.28, PAR% 44.0%) and central obesity (RR 2.45, 95% CI 1.45-3.70, PAR% 40.4%) were significantly associated with incident hypertension. Collectively, current smoking, high-normal blood pressure and central obesity accounted for 70.1% of all new cases of hypertension. Awareness, treatment and control rates of incident hypertension were 42.9%, 22.9% and 11.4%, respectively. CONCLUSIONS:This rural sample showed a high incidence of hypertension. This underscores the need for primary prevention of hypertension through lifestyle modification strategies targeting individuals with high-normal blood pressure, central obesity and current smoking. The healthcare system needs to improve the level of awareness, treatment and control of hypertension in this population.Item Incidence of Tobacco Use Among Adults (15-64 Years) in Rural Kerala(ASIA-PACIFIC JOURNAL OF PUBLIC HEALTH, 2015) Sathish, T; Kannan, S; Sarma, PS; Thankappan, KRWe analyzed data from a cohort study in rural Kerala, India, to study the incidence of current smoking and current smokeless tobacco use. At baseline, of 452 individuals aged 15 to 64 years, 385 were current nonsmokers and 402 were current nonusers of smokeless tobacco. Over a mean follow-up of 7.1 +/- 0.2 years, 5.5% became current smokers and 9.0% became current smokeless tobacco users. Among men, 21.1% (95% confidence interval [CI] = 11.1-36.4) of younger individuals (15-24 years) became current smokers and 22.2% (CI = 10.6-40.8) of older individuals (55-64 years) became current smokeless tobacco users. No women smoked both at baseline and at follow-up, but 9.7% (CI = 3.4-24.9) of older women (55-64 years) became current smokeless tobacco users. These findings call for effective implementation of India's Cigarettes and Other Tobacco Products Act, 2003.Item Incidence of tobacco use among adults (15-64 yrs) in rural Kerala(Asia Pacific J Public Health, 2013-06) Sathish, T; Kannan, S; Sarma, PS; Thankappan, KRWe analyzed data from a cohort study in rural Kerala, India, to study the incidence of current smoking and current smokeless tobacco use. At baseline, of 452 individuals aged 15 to 64 years, 385 were current nonsmokers and 402 were current nonusers of smokeless tobacco. Over a mean follow-up of 7.1 ± 0.2 years, 5.5% became current smokers and 9.0% became current smokeless tobacco users. Among men, 21.1% (95% confidence interval [CI] = 11.1-36.4) of younger individuals (15-24 years) became current smokers and 22.2% (CI = 10.6-40.8) of older individuals (55-64 years) became current smokeless tobacco users. No women smoked both at baseline and at follow-up, but 9.7% (CI = 3.4-24.9) of older women (55-64 years) became current smokeless tobacco users. These findings call for effective implementation of India’s Cigarettes and Other Tobacco Products Act, 2003.Item Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial(BMC Public Health, 2013-02) Daivadanam, M; Absetz, P; Sathish, T; Thankappan, KR; Fisher, EB; Philip, NE; Mathews, E; Oldenburg, BBackground 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.Item A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster randomized controlled trial of the Kerala Diabetes Prevention Program(Plos Medicine, 2018-06) Thankappan, KR; Sathish, T; Tapp, RJ; Shaw, JE; Lotfaliany, M; Wolfe, R; Absetz, P; Mathews, E; Aziz, Z; Emily, DBACKGROUND: 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.Item A risk score to predict hypertension in primary care settings in rural India(Asia-Pacific Journal of Public Health, 2015-09) Sathish, T; Kannan, S; Sarma, PS; Razum, O; Thrift, AG; Thankappan, KRWe used the data of 297 participants (15-64 years old) from a cohort study (2003-2010) who were free from hypertension at baseline, to develop a risk score to predict hypertension by primary health care workers in rural India. Age ≥35 years, current smoking, prehypertension, and central obesity were significantly associated with incident hypertension. The optimal cutoff value of ≥3 had a sensitivity of 78.6%, specificity of 65.2%, positive predictive value of 41.1%, and negative predictive value of 90.8%. The area under the receiver operating characteristic curve of the risk score was 0.802 (95% confidence interval = 0.748-0.856). This simple and easy to administer risk score could be used to predict hypertension in primary care settings in rural IndiaItem Screening Performance of Diabetes Risk Scores Among Asians and Whites in Rural Kerala, India(Prev Chronic Dis 2012, 2013-04) Sathish, T; Kannan, S; Sarma, SP; Thankappan, KRWe 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 IndiaItem Seven-year longitudinal change in risk factors for non-communicable diseases in rural Kerala, India: The WHO STEPS approach.(Plos one, 2017-06) Sathish, T; Kannan, S; Sarma, SP; Razum, O; Sauzet, O; Thankappan, KRNearly three-quarters of global deaths from non-communicable diseases (NCDs) occur in low- and middle-income countries such as India. However, there are few data available on longitudinal change in risk factors for NCDs in India. We conducted a cohort study among 495 individuals (aged 15 to 64 years at baseline) in rural Kerala state, India, from 2003 to 2010. For the present analysis, data from 410 adults (aged 20 to 64 years at baseline) who participated at both baseline and follow-up studies were analyzed. We used the World Health Organization STEPwise approach to risk factor surveillance for data collection. Age-adjusted change in risk factors for NCDs was assessed using the mixed-effects linear regression for continuous variables and the generalized estimating equation for categorical variables. The mean age of participants at baseline was 41.6 years, and 53.9% were women. The mean follow-up period was 7.1 years. There were significant increases in weight (mean change +5.0 kg, 95% confidence interval [CI] 4.2 to 5.8), body mass index (mean change +1.8 kg/m2 , 95% CI 1.5 to 2.1), waist circumference (mean change +3.9 cm, 95% CI 3.0 to 4.8), waist-toheight ratio (mean change +0.022, 95% CI 0.016 to 0.027), current smokeless tobacco use (men: odds ratio [OR] 1.6, 95% CI 1.1 to 2.2), alcohol use (men: OR 2.6, 95% CI 1.9 to 3.5; women: OR 4.8, 95% CI 1.8 to 12.6), physical inactivity (OR 2.0, 95% CI 1.3 to 3.0), obesity (OR 2.2, 95% CI 1.7 to 2.8), and central obesity (OR 1.9, 95% CI 1.5 to 2.3). Over a sevenyear period, several NCD risk factors have increased in the study cohort. This calls for implementation of lifestyle intervention programs in rural Kerala.