Enhanced enrollment in the National Diabetes Prevention Program for the underserved: a randomized control trial

增加服务不足的国家糖尿病预防计划的注册人数：一项随机对照试验

• 批准号: 9761661
• 负责人: Natalie Dawn Ritchie
• 金额: $ 58.54万
• 依托单位: DENVER HEALTH AND HOSPITAL AUTHORITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9761661
• 关键词: Adopted; Adult; Affect; Analysis of Covariance; Behavior Therapy; Body Weight decreased; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical Trials; Clinical effectiveness; Cohort Studies; Country; Data; Diabetes Mellitus; Education; Effectiveness; Effectiveness of Interventions; Enrollment; Ethnic Origin; Evidence based intervention; Future; Goals; Health; Healthcare Systems; Hispanics; Human Resources; Incidence; Income; Individual; Insurance Carriers; Intervention; Investments; Life Style; Logistic Regressions; Longitudinal cohort study; Low Income Population; Low income; Mediating; Mediator of activation protein; Medicare; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Outcome; Participant; Patients; Population Heterogeneity; Prediabetes syndrome; Preparation; Prevalence; Problem Solving; Program Effectiveness; Protocols documentation; Provider; Qualitative Evaluations; Race; Randomized; Randomized Controlled Trials; Readiness; Reporting; Research Project Grants; Resources; Risk; Self Efficacy; Site; Subgroup; Techniques; Testing; Time; Training; Translating; Underserved Population; Weight; Weight maintenance regimen; base; control trial; cost; demographics; diabetes prevention program; diabetes risk; disadvantaged population; disparity reduction; ethnic minority population; evidence base; health belief; health disparity; improved; innovation; intervention program; low socioeconomic status; motivational enhancement therapy; novel; prevent; primary outcome; programs; racial and ethnic; racial diversity; recruit; safety net; sociodemographics; success; treatment as usual; trial comparing; uptake

Project Summary Type 2 diabetes affects 9.4% of US adults with higher rates among racial/ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among Hispanic, non-Hispanic black, and low-income non-Hispanic white participants. Strategies to improve NDPP engagement and weight loss are needed urgently, especially for these subgroups. Pilot results of the Pre- NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a non-randomized cohort study among 1,140 racially diverse, predominately low-income participants. Outcomes of 75 Pre-NDPP participants who enrolled in the NDPP were compared to 1,065 prior participants using ANCOVA and multivariable logistic regression. Pre-session participants stayed in the NDPP 99.8 days longer (p<.001) and attended 14.3% more sessions (p<.001) on average than those without a pre- session. Pre-session participants lost 2.0% more weight (p<.001) and were 3.5 times more likely to achieve the 5% weight loss target (p<.001). Sensitivity analyses were consistent. Findings suggest pre-sessions may be a promising and pragmatic strategy to improve NDPP effectiveness and mitigate disparities in program outcomes, but a randomized controlled trial (RCT) is needed to determine whether Pre-NDPP reliably improves NDPP outcomes. The purpose of this study is to 1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive Pre-NDPP vs. direct enrollment into the NDPP (usual care), 2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race/ethnicity and income level), and 3) evaluate implementation factors, including cost and projected return on investment. The long-term goal is to disseminate a scalable, evidence-based strategy to improve success of the NDPP and reduce disparities in NDPP effectiveness. If found to be effective, Pre-NDPP can be disseminated to all NDPP providers, including more than 1,700 NDPP sites, and may be supported by current NDPP payers such as Medicare, commercial insurers, and employer groups. Thus, this approach has a high potential to impact the burden of type 2 diabetes and related health disparities across the country.

项目摘要 2型糖尿病会影响种族/族裔少数族裔较高比率较高的美国成年人的9.4％ 社会经济地位低。国家糖尿病预防计划（NDPP）是基于证据的， 通过适度的体重减轻，广泛传播的行为干预，以减少糖尿病的发生。 但是，为期一年的NDPP保留率是有问题的，导致体重减轻，尤其是在 西班牙裔，非西班牙裔黑人和低收入非西班牙裔白人参与者。改善NDPP的策略 紧急需要参与和减肥，尤其是对于这些亚组。前试验结果 NDPP是基于健康信念模型的NDPP入学的一种新颖的增强，高度 在1,140种种族多样性的低收入的种族多样性中，在非随机队列研究中取得了成功 参与者。将75名NDPP前参与者的成绩与1,065个之前的成绩进行了比较 参与者使用ANCOVA和多变量逻辑回归。会议前参与者留在NDPP 99.8天长（p <.001），平均参加14.3％的会议（p <.001） 会议。会议前参与者的体重增加了2.0％（p <.001），实现这一目标的可能性高3.5倍 5％减肥目标（p <.001）。灵敏度分析是一致的。调查结果表明，会议可能是 有希望和务实的策略，以提高NDPP的有效性并减轻计划的差异 结果，但是需要一个随机对照试验（RCT）来确定是否可靠 改善NDPP结果。这项研究的目的是1）进行RCT进行比较NDPP出席 与接收NDPP PRED PRICKANT的参与者之间的体重减轻结果 （通常的护理），2）检查潜在效应介体（感知的糖尿病和自我效能感和 准备体重控制）和主持人（种族/种族和收入水平），以及3）评估实施 因素，包括成本和预计投资回报率。长期目标是传播可扩展的， 基于证据的策略，以提高NDPP的成功并降低NDPP有效性的差异。如果 发现有效的是，NDPP可以传播给所有NDPP提供商，包括1,700多个NDPP 网站，可以得到当前NDPP付款人的支持，例如Medicare，商业保险公司和雇主 组。因此，这种方法具有影响2型糖尿病和相关健康的负担的高潜力 全国各地的差异。