Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Thankappan KR

PROVIDER: S-EPMC5991386 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Thankappan Kavumpurathu R KR Sathish Thirunavukkarasu T Tapp Robyn J RJ Shaw Jonathan E JE Lotfaliany Mojtaba M Wolfe Rory R Absetz Pilvikki P Mathews Elezebeth E Aziz Zahra Z Williams Emily D ED Fisher Edwin B EB Zimmet Paul Z PZ Mahal Ajay A Balachandran Sajitha S D'Esposito Fabrizio F Sajeev Priyanka P Thomas Emma E Oldenburg Brian B

PLoS medicine 20180606 6

<h4>Background</h4>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.<h4>Methods and findings ...[more]

PMID: 29874236

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Project description:BackgroundType 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).MethodsData 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.ResultsPrevalence 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.ConclusionThese 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.

Project description: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.

Project description:ObjectiveTo test the effectiveness of peer support for patients with type 2 diabetes.DesignCluster randomised controlled.Setting20 general practices in the east of the Republic of Ireland.Participants395 patients (192 in intervention group, 203 in control group) and 29 peer supporters with type 2 diabetes.InterventionAll practices introduced a standardised diabetes care system. The peer support intervention ran over a two year period and contained four elements: the recruitment and training of peer supporters, nine group meetings led by peer supporters in participant's own general practice, and a retention plan for the peer supporters.Main outcome measuresHbA(1c); cholesterol concentration; systolic blood pressure; and wellbeing score.ResultsThere was no difference between intervention and control patients at baseline. All practices and 85% (337) of patients were followed up. At two year follow-up, there were no significant differences in HbA(1c) (mean difference -0.08%, 95% confidence interval -0.35% to 0.18%), systolic blood pressure (-3.9 mm Hg, -8.9 to 1.1 mm Hg), total cholesterol concentration (-0.03 mmol/L, -0.28 to 0.22 mmol/L), or wellbeing scores (-0.7, -2.3 to 0.8). While there was a trend towards decreases in the proportion of patients with poorly controlled risk factors at follow-up, particularly for systolic blood pressure (52% (87/166) >130 mm Hg in intervention v 61% (103/169) >130 mm Hg in control), these changes were not significant. The process evaluation indicated that the intervention was generally delivered as intended, though 18% (35) of patients in the intervention group never attended any group meetings.ConclusionsA group based peer support intervention is feasible in general practice settings, but the intervention was not effective when targeted at all patients with type 2 diabetes. While there was a trend towards improvements of clinical outcomes, the results do not support the widespread adoption of peer support. Trial registration Current Controlled Trials ISRCTN42541690.

Project description:Abstract Objectives We sought to understand the feasibility, acceptability, and sustainability of using peer educators to deliver a worksite-based lifestyle intervention program to reduce cardiometabolic risk in India. Methods INtegrating DIAbetes prevention in WORKplaceS (INDIA-WORKS, Clinicaltrial.gov #NCT02813668) is an implementation study to evaluate a lifestyle intervention program targeting employees with prediabetes or newly diagnosed diabetes in ten worksites in India. Peer educators were recruited at each worksite and trained to teach lifestyle classes. We conducted in-depth interviews with managers (n = 16), peer educators (n = 29), and implementation team members (n = 8) and focus group discussions with employees participating in the program (n = 13) to evaluate program delivery, including use of peer educators in this setting. Interviews and focus groups were conducted in-person, audio-recorded, and transcribed verbatim. Data were analyzed using thematic analysis. Results Peer educators’ involvement in teaching classes varied across worksites. This variation was related to differences in the training peer educators received, degree of management support provided, and peer educators’ levels of confidence to teach classes (e.g., discuss nutrition topics). Most peer educators liked their role, as it allowed them to learn about lifestyle change and benefit other employees (e.g., by encouraging them to be physically active), themselves (e.g., by losing weight), and their families (e.g., by preparing and serving healthier meals at home). Many employees participating in the program were satisfied with the peer educators, though some preferred “experts” such as implementation team members to lead classes. For program sustainability, there remains a need to increase peer educators’ capacity to teach classes and maintain their motivation. Conclusions Findings indicate that while it may be feasible for peer educators to deliver worksite-based lifestyle programs in India, it is critical to ensure that they have confidence and training, management support, and motivation to carry out their role. Research is needed to understand the type of training and support necessary to develop a cadre of effective peer educators and strategies for sustaining their engagement in the program. Funding Sources NIH R01HL125442 NIH D43TW009337.

Project description:IntroductionThe Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.Study designA pragmatic, cluster randomized, mixed-methods study.Setting/particpantsClusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.InterventionImplementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.Main outcome measuresThe primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.ResultsStudy clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.ConclusionsIntervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.

Project description:BACKGROUND:Social support is known to reduce risks of postnatal depression (PND) and improve maternal emotional well-being. However, the Asian cultural context is often neglected when appraising maternal needs and mothers' preferences for social support. While many preventive efforts have experimented with technology, professionals, and paraprofessionals in providing social support to mothers in need, most studies determined the effectiveness of their interventions through quantitative measurements of maternal outcomes. Experiences and feedback from both participants and administrators are rarely discussed, especially in an Asian setting. OBJECTIVE:The goal of the research was to evaluate the postnatal experiences of Asian mothers at risk of PND and the perceptions of peer volunteers regarding a technology-based peer-support intervention program (PIP). METHODS:A qualitative semistructured interview was conducted with 20 Asian mothers at risk of depression (10 from the control group and 10 from the intervention group) and 19 peer volunteers from a randomized controlled trial. The PIP included weekly correspondence between peer volunteers and mothers through any telecommunication means over 4 weeks. All interviews were approximately 30 to 60 minutes long, audiotaped, transcribed verbatim, and analyzed using thematic analysis. Study findings were reported according to the Consolidated Standards of Reporting Trials checklist. RESULTS:Two overarching themes comprising five subthemes were generated: postnatal experience (a bouncy ride, a way forward) and evaluation of the PIP (valuable, flexible, and supportive program; building blocks of a good relationship; and lessons learned and the road ahead). Mothers from both the control and interventions groups were generally satisfied with hospital care and the support received from family. They also shared similar breastfeeding challenges and needs for more informed decisions and follow-up support from the hospital. However, mothers who received the PIP tended to have more positive outlooks of their birth experiences. Overall, peer volunteers and mothers involved in the PIP found the PIP useful and expressed satisfaction with the program's flexibility. They also shared their personal takeaways, the qualities of their friendships, and the need for extended correspondence time and recommended outreach to non-at-risk mothers. CONCLUSIONS:The positive endorsement of the PIP by peer volunteers and mothers suggests the success of the PIP in maintaining positive maternal emotional well-being during the postpartum period. With the help of technology, hospitals can easily provide additional peer support to at-risk mothers in addition to existing standard care offered to these mothers. TRIAL REGISTRATION:ISRCTN Registry ISRCTN14864807; http://www.isrctn.com/ISRCTN14864807. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/resprot.9416.

Dataset Information

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

Background

Methods and findings

Conclusions

Trial registration

Publications

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

Similar Datasets

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