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[Expert Solution]: Case Study: The Kerala Diabetes Prevention…

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Case Study: The Kerala Diabetes Prevention Program The Kerala Diabetes Prevention Program (K-DPP) stands as a notable phase II effectivenessimplementation hybrid trial (50) conducted within a low- and middle-income setting. The K-DPP was designed for implementation of an effective structured lifestyle intervention within rural communities in the Indian state of Kerala, as a modest, sustainable, and scalable program primarily facilitated by lay peer leaders (50). Kerala, in the advanced stage of epidemiological transition in India (51), with the highest prevalence of T2D in the country (52), is an ideal context for the implementation of a community-based diabetes prevention program in India. The intervention design of K-DPP was methodically formulated on the theoretical underpinnings of the “Health Action Process Approach” (53), a sociobehavioral framework. This model facilitated the systematic identification of determinants influencing behavior change, which were subsequently translated into learning objectives for program participants. The development of the K-DPP intervention drew on various sources of knowledge and best practices. Firstly, it integrated the fundamental principles of peer support outlined in the U.S. Peers for Progress program (54). Additionally, behavior change strategies were identified through a needs assessment study (55). Moreover, elements from established programs in high-income countries, including the U.S. DPP (9), the Good Ageing in Lahti Region (GOAL) program in Finland (56), and the Greater Green Triangle (GGT) project in Australia (57), were culturally adapted to suit the local context of Kerala (58). Prior to full-scale implementation, pilot testing was conducted in a implementation, pilot testing was conducted in a randomly selected community within the study area (59). This allowed for further refinement of both program objectives and intervention components based on real-world feedback and insights, ensuring that the intervention was effectively tailored to address the specific needs of the local population. The K-DPP enrolled a diverse population of 1,007 individuals at high risk, with 500 in the intervention group and 507 in the control group. This cohort included individuals across the entire glycemic spectrum, excluding only those with diabetes, with a high prevalence of several cardiometabolic risk factors (59). Moreover, the sociodemographic profile of K-DPP participants was similar to that of adults in rural Kerala (59), enhancing the generalizability of the findings to a broader population at high risk. Peer group sessions were conducted by trained lay peer leaders, with one male and one female leader per group, selected from within the group based on their willingness, social credibility, and acceptability according to their peers (60). These sessions took place in local community facilities, such as schools or community halls, scheduled over weekends at times convenient for participants, and typically lasted 60-90 min. Of note, besides receiving training and ongoing support from the K-DPP staff throughout the intervention period, the peer leaders did not receive any incentives. The lifestyle change strategies focused on increasing physical activity through identification of enjoyable activities for both individuals and groups and incorporating them into daily routines (60). Dietary guidance included increasing fruit and vegetable consumption, reducing portion sizes of rice, and minimizing intake of fried foods and refined sugars. Participants used goal setting, action planning, and self-recording of activities as key behavioral strategies for enhancing physical activity and adopting healthy eating habits. Outside of formal peer group The K-DPP trial replicated some of the major findings of landmark efficacy trials in the significant reduction of diabetes incidence, by

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