Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

 描述(由申请人提供)：亚裔印度人有很高的糖尿病、糖尿病前期和心脏代谢危险因素的比率。有强有力的证据表明，改变生活方式，特别是减肥、增加体力活动和改善饮食质量，可以预防或推迟糖尿病，减少血糖、血脂和血压升高等心脏代谢风险因素，并改善糖尿病患者的预后。在工作场所实施改变生活方式的教育和支持，可能是以可接受、可获得和可持续的方式提供预防的有效和成本效益高的方法，并克服改变生活方式的障碍(例如，缺乏时间或资源)。在国际研究小组先前工作的基础上，这项研究建议在设计前试验中实施和评估基于工作场所的生活方式改善方案的可接受性、交付、有效性和成本效益，包括同行主导的生活方式改变教育计划，以及工作场所环境的变化，以促进社会支持、健康饮食和锻炼。生活方式教育计划将包括印度八个不同工作场所的2000名患有糖尿病前期(HbA1c为5.7-6.4%)或未用药糖尿病(筛查发现HbA1c=6.5%)的成年人(工作场所环境的变化将影响更广泛的员工群体)。将采用混合方法评估该方案的执行情况。这项研究旨在衡量：(1)计划实施的成功程度(生活方式课程参与者的体重、饮食和身体活动行为的参与和变化)；对计划的忠诚度(与学习相关的工作场所工作人员的活动；工作场所食堂食物选择的变化；对计划的管理支持；以及工作场所环境的变化)；以及在深入的半结构化访谈和焦点小组讨论中，员工、经理、主管和生活方式教育计划参与者和退学者报告的计划可接受性。(2)通过评估为降低血压、甘油三酯和糖化血红蛋白(主要结果)而达到的心脏代谢风险目标的数量，以及通过改变次要结果(包括糖尿病发病率和回归正常血糖的比率以及人体测量学、血脂和空腹血糖的变化)来评估计划的有效性。(3)通过评估计划成本、成本效益以及员工生产率、缺勤率、健康状况和生活质量的变化，为雇主评估计划的价值和投资回报。该项目将提供科学创新(生活方式教育计划，在维护期间提供短信支持)、社会创新(受过教育的同行健康教育者向大量高危人群提供计划)和商业创新(工作场所利益相关者承诺和合作研究人员，以帮助忠实地交付计划，改善工作场所健康环境，并评估模式)。如果该计划在这些工地被证明是可行的、可接受的、有效的和具有成本效益的，该计划可以传播到整个印度和其他地方的其他工地。

 DESCRIPTION (provided by applicant): Asian Indians have high rates of diabetes, prediabetes and cardio metabolic risk factors. There is strong evidence that lifestyle change, particularly weight loss, increasing physical activity, and improving diet quality can prevent or delay diabetes, reduce cardiometabolic risk factors such as elevated glucose, plasma lipids, and blood pressure, and improve outcomes among individuals with diabetes. Implementing lifestyle change education and support at the worksite may be an effective and cost-effective method to deliver prevention in a way that is acceptable, accessible, and sustainable and overcomes barriers to lifestyle change (e.g., lack of time or resources). Building off previous work by the international study team, this study proposes implementing and evaluating in a pre-post design trial the acceptability, delivery, effectiveness, and cost- effectiveness of a worksite-based lifestyle improvement package including a peer-led lifestyle change education program augmented with changes in the worksite environment that promote social support, healthy eating and exercise. The lifestyle education program will include 2000 adults with prediabetes (HbA1c of 5.7- 6.4%) or unmedicated diabetes (HbA1c = 6.5% identified at screening) across eight diverse worksites in India (changes to the worksite environment will impact a much broader population of employees). A mixed methods approach will be used to evaluate implementation of the program. The study aims to measure: (1) Success of implementation in terms of program adoption (participation and changes in weight and diet and physical activity behaviors among lifestyle class participants); fidelity to the program (activities of study-affiliaed worksite staff; changes to the food options at the worksite canteen; management support for the program; and changes in the worksite environment); and program acceptability as reported by employees, managers, supervisors, and lifestyle education program participants and dropouts during in-depth, semi-structured interviews and focus group discussions. (2) Program effectiveness by evaluating the number of cardiometabolic risk goals reached for reductions in blood pressure, triglycerides, and HbA1c (the primary outcome) and through changes in secondary outcomes including rates of diabetes incidence and regression to normoglycemia and changes in anthropometry, lipids, and fasting glucose. (3) Value and return on the investment of the program for employers by assessing program costs, cost-effectiveness, and changes in staff productivity, absenteeism, health status, and quality of life. This project will deliver scientific innovations (lifestyle education programs with text message supports during maintenance) with social innovations (educated peer health educators delivering a program to a large at risk population) and business innovation (worksite stakeholder commitment and partnering researchers to help deliver the program with fidelity, improve the workplace health environment, and evaluate the model). If the program is shown to be feasible, acceptable, effective, and cost-effective at these worksites, the program could be disseminated to other worksites throughout India and elsewhere.