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.

Strengthening Capacity for Implementation Research Amid COVID-19 Pandemic: Learnings From the Global Alliance for Chronic Diseases Implementation Science School.

Objective: To describe the design, delivery and evaluation of the 3rd Global Alliance for Chronic Diseases (GACD) Implementation Science School (ISS), delivered virtually in 2020 for the first time. Methods: Since 2014, GACD has supported the delivery of more than ten Implementation Science Workshops for more than 500 international participants. It has also been conducting an annual ISS since 2018. In this study, we described the design, delivery and evaluation of the third ISS. Results: Forty-six participants from 23 countries in five WHO regions attended the program. The virtual delivery was well-received and found to be efficient in program delivery, networking and for providing collaborative opportunities for trainees from many different countries. The recently developed GACD Implementation Science e-Hub was found to be an instrumental platform to support the program by providing a stand-alone, comprehensive online learning space for knowledge and skill development in implementation research. Conclusion: The delivery of the virtual GACD ISS proved to be feasible, acceptable and effective and offers greater scalability and sustainability as part of a future strategy for capacity strengthening in implementation research globally.

Out of sight, but not out of mind: a case study of the collaborative development of a university-wide orientation resource for online students.

The global online education sector has been rising rapidly, particularly during and after the events of 2020, and is becoming mainstream much sooner than expected. Despite this, research studies report higher levels of perceived isolation, difficulties with engagement, and higher attrition rates in online compared to equivalent on-campus programs. Reasons include restrictions to the type of institutional support accessible by online students, and the lack of comprehensiveness of orientation resources. This paper describes the collaborative efforts by a cross-faculty academic team, supported by a community of practice, to create a university-wide online orientation resource-the Monash Online Learning Hub (MOLH). The development of the MOLH involved multiple phases, including an analysis of current practice, resource design and content creation, formative evaluation by staff and students, and successful integration into the university's mainstream student orientation platform for widescale implementation. The methods adopted were varied, and involved generating both qualitative and quantitative data across multiple phases of development from online education experts at the University, that culminated in the gradual building and refinement of the MOLH. Final outcomes, implications and lessons learned are also discussed in this paper.

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.

Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program.

BACKGROUND: Data on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India. METHODS: The Kerala Diabetes Prevention Program was conducted in 60 polling areas (electoral divisions) of the Neyyatinkara taluk (subdistrict) in Trivandrum district, Kerala state. Individuals (age 30-60 years) were screened with the Indian Diabetes Risk Score (IDRS) at their homes followed by an oral glucose tolerance test (OGTT) at community-based clinics. Individuals at high-risk of developing diabetes (IDRS score ≥60 and without diabetes on the OGTT) were recruited. RESULTS: A total of 1007 participants (47.2% women) were recruited over nine months. Pilot testing, personal contact and telephone reminders from community volunteers, and gender matching of staff were effective recruitment strategies. The major recruitment challenges were: (1) during home visits, one-third of potential participants could not be contacted, as they were away for work; and (2) men participated less frequently in the OGTT screening than women (75.2% vs. 84.2%). For non-participation, lack of time (42.0%) was most commonly cited followed by 'I am already feeling healthy' (30.0%), personal reasons (24.0%) and 'no benefit to me or my family' (4.0%). An average of 17 h were spent to recruit one participant with a cost of US$23. The initial stage of screening and recruitment demanded higher time and costs. CONCLUSIONS: This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

A group-based lifestyle intervention for diabetes prevention in low- and middle-income country: implementation evaluation of the Kerala Diabetes Prevention Program.

BACKGROUND: 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. TRIAL REGISTRATION: Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909 . Registered 10 March 2011.

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.

Peer support to improve diabetes care: an implementation evaluation of the Australasian Peers for Progress Diabetes Program.

BACKGROUND: Several studies have now demonstrated the benefits of peer support in promoting diabetes control. The aim of this study is to evaluate the implementation of a cluster randomised controlled trial of a group-based, peer support program to improve diabetes self-management and thereby, diabetes control in people with Type 2 Diabetes in Victoria, Australia. METHODS: The intervention program was designed to address four key peer support functions i.e. 1) assistance in daily management, 2) social and emotional support, 3) regular linkage to clinical care, and 4) ongoing and sustained support to assist with the lifelong needs of diabetes self-care management. The intervention participants attended monthly group meetings facilitated by a trained peer leader for 12 months. Data was collected on the intervention's reach, participation, implementation fidelity, groups' effectiveness and participants' perceived support and satisfaction with the intervention. The RE-AIM and PIPE frameworks were used to guide this evaluation. RESULTS: The trial reached a high proportion (79%) of its target population through mailed invitations. Out of a total of 441 eligible individuals, 273 (61.9%) were willing to participate. The intervention fidelity was high (92.7%). The proportion of successful participants who demonstrated a reduction in 5 years cardiovascular disease risk score was 65.1 and 44.8% in the intervention and control arm respectively. Ninety-four percent (94%) of the intervention participants stated that the program helped them manage their diabetes on a day to day basis. Overall, attending monthly group meetings provided 'a lot of support' to 57% and 'moderate' support to 34% of the participants. CONCLUSION: Peer support programs are feasible, acceptable and can be used to supplement treatment for patients motivated to improve behaviours related to diabetes. However, program planners need to focus on the participation component in designing future programs. The use of two evaluation frameworks allowed a comprehensive evaluation of the trial from the provider-, participant- and public health perspective. The learnings gained from this evaluation will guide and improve future implementation by improving program feasibility for adoption and acceptability among participants, and will ultimately increase the likelihood of program effectiveness for the participants. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009.

Cultural adaptation of a peer-led lifestyle intervention program for diabetes prevention in India: the Kerala diabetes prevention program (K-DPP).

BACKGROUND: 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 2011.

A systematic review of real-world diabetes prevention programs: learnings from the last 15 years.

BACKGROUND: The evidence base for the prevention of type 2 diabetes mellitus (T2DM) has progressed rapidly from efficacy trials to real-world translational studies and practical implementation trials over the last 15 years. However, evidence for the effective implementation and translation of diabetes programs and their population impact needs to be established in ways that are different from measuring program effectiveness. We report the findings of a systematic review that focuses on identifying the critical success factors for implementing diabetes prevention programs in real-world settings. METHODS: A systematic review of programs aimed at diabetes prevention was undertaken in order to evaluate their outcomes using the penetration, implementation, participation, and effectiveness (PIPE) impact metric. A search for relevant articles was carried out using PubMed (March 2015) and Web of Science, MEDLINE, CENTRAL, and EMBASE. A quality coding system was developed and included studies were rated independently by three researchers. RESULTS: Thirty eight studies were included in the review. Almost all (92 %) provided details on participation; however, only 18 % reported the coverage of their target population (penetration). Program intensity or implementation-as measured by frequency of contacts during first year and intervention duration-was identified in all of the reported studies, and 84 % of the studies also reported implementation fidelity; however, only 18 % of studies employed quality assurance measures to assess the extent to which the program was delivered as planned. Sixteen and 26 % of studies reported 'highly' or 'moderately' positive changes (effectiveness) respectively, based on weight loss. Six (16 %) studies reported 'high' diabetes risk reduction but 'low' to 'moderate' weight loss only. CONCLUSION: Our findings identify that program intensity plays a major role in weight loss outcomes. However, programs that have high uptake-both in terms of good coverage of invitees and their willingness to accept the invitation-can still have considerable impact in lowering diabetes risk in a population, even with a low intensity intervention that only leads to low or moderate weight loss. From a public health perspective, this is an important finding, especially for resource constrained settings. More use of the PIPE framework components will facilitate increased uptake of T2DM prevention programs around the world.

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.