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: 10380172
• 负责人: Natalie Dawn Ritchie
• 金额: $ 55.52万
• 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/10380172
• 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; Hispanic; Human Resources; Incidence; Income; 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; Reach Effectiveness Adoption Implementation and Maintenance; Readiness; Reporting; Research Project Grants; Resources; Risk; Self Efficacy; Site; Subgroup; Techniques; Testing; Time; Training; Translating; Underserved Population; Weight; Weight maintenance regimen; base; cost; demographics; diabetes prevention program; diabetes risk; disadvantaged population; disparity reduction; ethnic minority population; evidence base; health belief; health disparity; implementation determinants; implementation evaluation; improved; innovation; intervention program; low socioeconomic status; motivational enhancement therapy; novel; pilot test; prevent; primary outcome; programs; racial and ethnic; racial diversity; recruit; safety net; sociodemographic variables; 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.

项目概要 9.4% 的美国成年人患有 2 型糖尿病，其中少数族裔/族裔和以下人群的患病率较高 社会经济地位低。国家糖尿病预防计划 (NDPP) 是一项基于证据的、 广泛传播的行为干预措施，通过适度减轻体重来降低糖尿病发病率。 然而，保留一年的 NDPP 是有问题的，会导致体重减轻不理想，尤其是在人群中 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。改进 NDPP 的策略 迫切需要参与和减肥，特别是对于这些亚群体。预试验结果 NDPP 是基于健康信念模型的 NDPP 入学新改进，受到高度评价 在一项针对 1,140 名不同种族、主要是低收入人群的非随机队列研究中取得成功 参与者。将 75 名参加 NDPP 的 Pre-NDPP 参与者的结果与之前的 1,065 名参与者进行了比较 参与者使用ANCOVA和多变量逻辑回归。会前参与者留在NDPP 与没有预习的人相比，平均延长了 99.8 天 (p<.001)，参加的课程多了 14.3% (p<.001) 会议。会前参与者的体重减轻了 2.0% (p<.001)，实现目标的可能性增加了 3.5 倍 5% 减肥目标 (p<.001)。敏感性分析是一致的。研究结果表明，会前会议可能是 提高 NDPP 有效性并减少计划差异的有前途且务实的战略 结果，但需要随机对照试验 (RCT) 来确定 Pre-NDPP 是否可靠 改善 NDPP 成果。本研究的目的是 1) 进行一项随机对照试验，比较 NDPP 的出席率 接受 Pre-NDPP 的参与者与直接加入 NDPP 的参与者之间的减肥结果 （常规护理），2）检查潜在的影响中介因素（感知的患糖尿病的风险和自我效能感以及 体重控制准备情况）和调节者（种族/民族和收入水平），以及 3) 评估实施情况 因素，包括成本和预计投资回报。长期目标是传播可扩展的、 以证据为基础的战略，以提高 NDPP 的成功率并减少 NDPP 有效性的差异。如果 如果发现有效，Pre-NDPP 可以分发给所有 NDPP 提供者，包括 1,700 多个 NDPP 网站，并可能得到当前 NDPP 付款人（例如 Medicare、商业保险公司和雇主）的支持 组。因此，这种方法很有可能影响 2 型糖尿病和相关健康的负担 全国各地的差距。