Culturally-adapted DPP intervention for Mexican Americans in primary care: An RCT

描述(由申请人提供)：背景：拉美裔是美国人口中规模最大、增长最快的少数群体(占美国人口的16%)，是美国种族/民族之间现存健康差距的有力例证。特别是，墨西哥裔美国人--美国最大的拉丁裔亚群--超重和肥胖率(80%)明显高于非西班牙裔白人(68%)，而且他们受到肥胖相关风险因素(如代谢综合征、糖尿病前期)和疾病(如糖尿病)的影响不成比例。在有效的体重管理生活方式干预措施付诸实践之前，肥胖及其共病将继续带来巨大和不成比例的负担。需要针对人群的干预措施，因为无差别干预措施(通常是在白人占主导地位的人群中制定的)可能效率低下，甚至无意中增加了健康差距。糖尿病预防计划(DPP)试验表明，在高危成年人中，密集的生活方式干预将2型糖尿病的发病率降低了58%，体重减轻是主要的预测因素。已经进行了大量的DPP翻译研究，包括我们的团队最近完成的有241名参与者(78%的nhw)的务实随机试验(E-Lite)，该试验表明，成功地将团体咨询与卫生信息技术(HIT)相结合，以实施初级保健中的DPP干预。到目前为止，民进党针对拉丁裔的翻译研究很少。设计：我们建议从文化上调整E-Lite中的IT增强型DPP干预小组，并在讲西班牙语或双语的墨西哥裔美国人中进行测试，这些美国人超重或肥胖，并患有代谢综合征、糖尿病前期或两者兼有。来自加利福尼亚州圣克鲁斯6个初级保健诊所的参与者(n=186)(35%是拉丁裔居民，91%是墨西哥裔)将被随机分配接受文化适应干预(CAI)或常规护理。主要目的是确定计算机辅助教学(RE-AIM模型中的“E”)的有效性。我们假设，与常规护理相比，计算机辅助治疗将导致24个月后(主要结果)体重指数的平均下降幅度更大。次要结果将包括成本效益、临床(例如空腹血糖)、心理社会(例如生活质量)、行为改变(例如饮食、体力活动)措施。次级人工智能将利用混合方法对其他RE-AIM属性进行过程评估：达到(例如，目标人群的参与率)、采用(例如，参与临床和提供特征)、实施(例如，干预保真度)和维护(例如，在实践环境中的可持续性)。影响：该卫生服务研究项目(PA-13-045)属于AHRQ研究组合领域，即相对有效性、HIT以及预防和护理管理；它还针对优先人群。这些发现将对临床医生、患者和其他决策者具有价值，这些决策者正在考虑为数百万MA提供有效的肥胖和糖尿病预防计划，这些人背负着不成比例的肥胖和糖尿病负担，具有很高的现实适用性和对MA少数民族健康的影响，以及旨在消除健康差距的政策。

DESCRIPTION (provided by applicant): Background: Latinos are the largest and fastest growing minority group (16% of the US population) and provide a potent example of existing health disparities among U.S. racial/ethnic groups. In particular, Mexican Americans-the largest US Latino subpopulation-have a notably higher prevalence of overweight and obesity (80%) than non-Hispanic whites (NHWs, 68%), and they are disproportionately affected by obesity-related risk factors (e.g., metabolic syndrome, pre-diabetes) and diseases (e.g., diabetes). Until efficacious lifestyle interventions for weight management are translated into practice, obesity and its comorbidities will continue to exact enormous and disproportionate burdens. Population-specific interventions are needed because undifferentiated interventions (often developed in white-dominant populations) may be inefficient-or even unintentionally increase health disparities. The Diabetes Prevention Program (DPP) trial demonstrated that an intensive lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults and that weight loss was the dominant predictor. Numerous DPP translation studies have been undertaken, including a pragmatic randomized trial our team recently completed ("E-LITE") with 241 participants (78% NHW) that showed success in integrating group counseling with health information technology (HIT) to operationalize the DPP intervention in primary care. To date, very few DPP translation studies have targeted Latinos. Design: We propose to culturally adapt the IT-enhanced group DPP intervention from E-LITE and test it among Spanish-speaking or bilingual Mexican Americans who are overweight or obese and have metabolic syndrome, pre-diabetes, or both. Participants (n=186) from 6 primary care practices in Santa Cruz, California (35% Latino residents; 91% of Mexican origin) will be randomly assigned to receive the culturally adapted intervention (CAI) or usual care. The primary aim is to determine the effectiveness of the CAI ("E" in the RE-AIM model). We hypothesize that the CAI will lead to a greater mean reduction in body mass index at 24 months (primary outcome) vs. usual care. Secondary outcomes will include cost-effectiveness, clinical (e.g., fasting glucose), psychosocial (e.g., quality of life), behavior change (e.g., diet, physical activity) measures. The secondary ai is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., participating clinic & provide characteristics), Implementation (e.g., intervention fidelity), and Maintenance (e.g., sustainabiliy in the practice setting). Implications: This health services research project (PA-13-045) falls within the AHRQ Research Portfolio areas of comparative effectiveness, HIT, and prevention and care management; it also targets a priority population. The findings will be of value to clinicians, patients, and other decision makers considering effective obesity and diabetes prevention programs for the millions of MAs who carry a disproportionate burden of these, with high potential for real-world applicability and impact on MA minority health and policies aimed to eliminate health disparities.