Browsing by Author "Balachandran, S"
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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 Cultural adaptation of a peer-led lifestyle intervention program for diabetes prevention in India: the Kerala diabetes prevention program (K-DPP)(BMC Public Health, 2018-01) Mathews, E; Thomas, E; Absetz, P; D’Esposito, F; Aziz, Z; Balachandran, S; Daivadanam, M; Thankappan, KR; Oldenburg, BBackground: Type 2 diabetes mellitus (T2DM) is now one of the leading causes of disease-related deaths globally. India has the world’s second largest number of individuals living with diabetes. Lifestyle change has been proven to be an effective means by which to reduce risk of T2DM and a number of “real world” diabetes prevention trials have been undertaken in high income countries. However, systematic efforts to adapt such interventions for T2DM prevention in low- and middle-income countries have been very limited to date. This research-to-action gap is now widely recognised as a major challenge to the prevention and control of diabetes. Reducing the gap is associated with reductions in morbidity and mortality and reduced health care costs. The aim of this article is to describe the adaptation, development and refinement of diabetes prevention programs from the USA, Finland and Australia to the State of Kerala, India. Methods: The Kerala Diabetes Prevention Program (K-DPP) was adapted to Kerala, India from evidence-based lifestyle interventions implemented in high income countries, namely, Finland, United States and Australia. The adaptation process was undertaken in five phases: 1) needs assessment; 2) formulation of program objectives; 3) program adaptation and development; 4) piloting of the program and its delivery; and 5) program refinement and active implementation. Results: The resulting program, K-DPP, includes four key components: 1) a group-based peer support program for participants; 2) a peer-leader training and support program for lay people to lead the groups; 3) resource materials; and 4) strategies to stimulate broader community engagement. The systematic approach to adaptation was underpinned by evidence-based behavior change techniques. Conclusion: K-DPP is the first well evaluated community-based, peer-led diabetes prevention program in India. Future refinement and utilization of this approach will promote translation of K-DPP to other contexts and population groups within India as well as other low- and middle-income countries. This same approach could also be applied more broadly to enable the translation of effective non-communicable disease prevention programs developed in high-income settings to create context-specific evidence in rapidly developing low- and middle-income countries. Trial registration: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909. Registered 10 March 2011Item . 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 The Role of the Sewing Ring in Tissue Healing: A Pathologic Study of Explanted Mechanical Heart Valves(JOURNAL OF HEART VALVE DISEASE, 2012) Kurian, MV; Sabareeswaran, A; Kanchanamala, M; Balachandran, S; Mogileswari, D; Subban, VBackground and aim of the study: Serious complications may occur after heart valve replacement, and many such patients will require reoperation. The study aim was to identify the pattern of tissue response around the sewing ring of those valves that have been explanted as a result of various valve-associated complications. Methods: A total of 51 mechanical heart valves (MHVs) was explanted from 45 patients who had undergone reoperation for valve-related complications. The examination of the valves included an analysis of the operative findings, macroscopic findings, histopathology, and dissection of the sewing ring. Results: The extent of tissue hyperplasia was variable around the sewing rings of valves explanted for various pathologies. In pannus, the hyperplastic tissue extended into the valve orifice and produced an obstruction to flow, whereas in thrombosed valves the thrombus was attached to the tissue at the annulus. In non-infective pathologies, the histology revealed cellular infiltration that was limited to the peripheral fabric layers of the sewing ring, though the extent of infiltration was not increased with the duration of implantation. In prosthetic valve endocarditis (PVE), the surrounding hyperplastic tissue was granulomatous, but cellular infiltration into the sewing ring was absent. The dissection of various models of explanted valves revealed that different types of filler and fixing mechanisms had increased the bulk of the sewing ring. Conclusion: Tissue hyperplasia of varying extent occurs around the sewing ring after MHV implantation. The cellular elements grow into the peripheral layers, but not the deeper layers, of the sewing ring. In PVE, there was an absence of cellular infiltration into the sewing ring. The Journal of Heart Valve Disease 2012;21:253-259