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型糖尿病影响9.4%的美国成年人，少数种族/民族和 社会经济地位低下。国家糖尿病预防计划（NDPP）是一项基于证据的计划， 广泛传播的行为干预，通过适度减肥降低糖尿病发病率。 然而，在长达一年的NDPP中的保留是有问题的，并导致次优的体重减轻，特别是在 西班牙裔、非西班牙裔黑人和低收入非西班牙裔白色参与者。改善NDPP的战略 迫切需要参与和减肥，特别是对这些亚群体。试点成果预 NDPP是一种基于健康信念模型的NDPP注册的新增强， 在1,140名种族多样、主要是低收入者中进行的非随机队列研究中取得成功 参与者将参加NDPP的75名Pre-NDPP参与者的结果与1，065名先前参与者的结果进行了比较。 使用ANCOVA和多变量logistic回归分析。会前与会者留在国家发展方案 99.8与那些没有预先治疗的人相比，他们的平均治疗时间延长了14.3%（p<.001）， 上网时段会前参与者减轻了2.0%的体重（p<0.001），并且达到预期目标的可能性增加了3.5倍。 5%体重减轻目标（p<.001）。敏感性分析是一致的。研究结果表明，会前会议可能是一个 提高NDPP有效性和减少方案差异的有前途和务实的战略 结果，但需要随机对照试验（RCT）来确定是否Pre-NDPP可靠 改善NDPP结果。本研究的目的是1）进行一项随机对照试验，比较NDPP的出勤率 接受Pre-NDPP与直接入组NDPP的参与者之间的体重减轻结果 （常规护理），2）检查潜在效应介质（发生糖尿病的感知风险和自我效能， 准备体重控制）和调节（种族/民族和收入水平），以及3）评估实施情况 这些因素包括成本和预计投资回报。长期目标是传播一个可扩展的， 以证据为基础的战略，以提高国家发展方案的成功率，并减少国家发展方案有效性方面的差距。如果 如果被认为是有效的，可以向所有NDPP提供者传播NDPP前，包括1，700多个NDPP 网站，并可能由目前的NDPP付款人，如医疗保险，商业保险公司和雇主支持 组因此，这种方法有很大的潜力影响2型糖尿病和相关健康的负担 全国各地的差距。