Adapting the Diabetes Prevention Program for a developing world context

调整糖尿病预防计划以适应发展中国家的情况

• 批准号: 9242053
• 负责人: DELWYN CATLEY
• 金额: $ 66.69万
• 依托单位: CHILDREN'S MERCY HOSP (KANSAS CITY, MO)
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-15 至 2020-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9242053
• 关键词: Behavior Therapy; Blood Pressure; Body Weight decreased; Cardiovascular Diseases; Cardiovascular system; Cellular Phone; Chronic Disease; Cluster randomized trial; Communicable Diseases; Communication; Communities; Community Developments; Community Health Aides; Cost Analysis; Country; Developing Countries; Development; Diabetes Mellitus; Diet; Disease; Economics; Educational Curriculum; Effectiveness; Effectiveness of Interventions; Familiarity; Fatty acid glycerol esters; Glycosylated hemoglobin A; Health Club; Healthcare Systems; Hypertension; Individual; Institution; Intake; Intervention; Language; Life Style; Lipids; Malnutrition; Manuals; Measures; Modeling; Nature; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Overweight; Ownership; Participant; Pharmaceutical Preparations; Physical activity; Physicians; Prevalence; Process; Public Health; Randomized; Resources; Risk; Risk Factors; South Africa; Southern Africa; Stroke; Supervision; System; Testing; Text; Trainers Training; Training; Universities; Waiting Lists; Work; base; blood glucose regulation; cardiovascular risk factor; community based participatory research; cost; cost effectiveness; diabetes prevention program; diabetes risk; experience; follow-up; fruits and vegetables; health related quality of life; improved; lifestyle intervention; motivational enhancement therapy; neglect; primary outcome; programs; public health relevance; satisfaction; secondary outcome; skills; skills training; social; treatment as usual

 DESCRIPTION (provided by applicant): As a result of globalization and economic advancement countries like South Africa (SA) are experiencing a "risk transition" in which disease prevalence is shifting from being primarily infectious in nature to being primarily non-communicable in nature. This is presenting significant challenges for the health care systems of countries with scarce resources. In the U.S. evidence from large, rigorous RCT's clearly indicate that lifestyle interventions such as the Diabetes Prevention Program (DPP) can enable overweight individuals to change their diet and physical activity levels and significantly reduce their risk for diabetes mellitus (DM) and cardiovascular (CVD) diseases but the program has not been adapted for delivery in a developing word setting. The purpose of this proposal is to adapt the DPP and evaluate its feasibility and effectiveness in an urban settlement community in SA. Three initial adaptations to the DPP are proposed for this setting: (1) deliver treatment in a group format using community health workers (CHWs); (2) enhance the DPP through interactive text messaging; and (3) enhance CHW's communications skills through simplified Motivational Interviewing (MI) training. The RE-AIM model will be used to guide our intervention adaptations in order to maximize public health impact. Feasibility and effectiveness of the DPP-SA will be assessed in a "real world" trial using a large team of CHWs currently deployed in this community to help overweight/obese individuals with DM and/or CVD. We plan a 2 year cluster-randomized trial in which we will randomize 54 existing "health clubs" (N=540) to receive the DPP South Africa (DPP-SA) or usual care (wait-list). The primary outcome analysis will compare percentage of baseline weight loss at Y1 between DPP-SA and usual care; however, after Y1 usual care participants will also receive the DPP-SA and both groups will be followed for another year. This will allow us to assess whether the wait-list group's results after 1 year of treatment are similar to the original group's outcomes and examine whether the original group maintains its outcomes over 2 years. Secondary outcomes will include DM and cardiovascular risk indicators (blood pressure, hemoglobin A1C, lipids), changes in medication use, diet (fat and fruit and vegetable intake), physical activity, and health related quality of life. Feasibilityand process outcomes will be assessed among NGO staff, CHWs, and participants. We will also prepare the DPP-SA for dissemination through development of training curricula, establishing university training courses, engaging other stakeholders who are candidates for dissemination, and assessing the cost-effectiveness of the intervention with respect to cost per kg of weight loss and key secondary outcomes.

 描述（由申请人提供）：由于全球化和经济进步，南非（SA）等国家正在经历一个“风险过渡”，其中疾病流行率从主要传染性性质转变为主要非传染性性质。这给资源稀缺国家的卫生保健系统带来了重大挑战。在美国，来自大型严格RCT的证据清楚地表明，生活方式干预，如糖尿病预防计划（DPP）可以使超重个体改变他们的饮食和体育活动水平，并显着降低他们患糖尿病（DM）和心血管（CVD）疾病的风险，但该计划尚未适应发展中国家的环境。本提案的目的是调整DPP并评估其在南澳城市定居社区的可行性和有效性。针对这种情况，提出了对DPP的三个初步调整：（1）使用社区卫生工作者（CHW）以小组形式提供治疗;（2）通过交互式短信增强DPP;（3）通过简化动机访谈（MI）培训增强CHW的沟通技能。RE-AIM模型将用于指导我们的干预措施，以最大限度地提高公共卫生影响。DPP-SA的可行性和有效性将在一项“真实的世界”试验中进行评估，该试验使用了目前部署在该社区的大型CHW团队，以帮助患有DM和/或CVD的超重/肥胖个体。我们计划进行一项为期2年的随机分组试验，在该试验中，我们将随机选择54个现有的“健康俱乐部”（N=540）接受DPP南非（DPP-SA）或常规护理（等待名单）。主要结局分析将比较DPP-SA和常规治疗之间在Y1时基线体重减轻的百分比;然而，在Y1常规治疗后，受试者还将接受DPP-SA，两组将再随访一年。这将使我们能够评估等待名单组在治疗1年后的结果是否与原始组的结果相似，并检查原始组是否在2年内保持其结果。次要结局将包括DM和心血管风险指标（血压、血红蛋白A1 C、血脂）、药物使用变化、饮食（脂肪和水果蔬菜摄入量）、体力活动和健康相关生活质量。将在非政府组织工作人员、社区工作者和参与者中评估可行性和进程成果。我们还将通过制定培训课程、设立大学培训课程、让其他可能传播的利益攸关方参与以及评估干预措施在每公斤减肥成本和关键次要结果方面的成本效益，为传播DPP-SA做好准备。