Kansas Center for Metabolism and Obesity REsearch (KC-MORE) - Project 3

堪萨斯代谢和肥胖研究中心 (KC-MORE) - 项目 3

• 批准号: 10598053
• 负责人: Anna Michael Gorczyca
• 金额: $ 29.71万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-12-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10598053
• 关键词: Administrator; Adult; Agriculture; Body Weight; Body Weight decreased; Centers for Disease Control and Prevention (U.S.); Centers of Research Excellence; Cluster randomized trial; Community Services; County; County Government; Diabetes Mellitus; Diet; Dissemination and Implementation; Distance Learning; Education; Educational Curriculum; Effectiveness; Evaluation; Facebook; Facebook delivery; Family; Fatty acid glycerol esters; Focus Groups; Funding; Glycosylated hemoglobin A; Goals; Grant; Health; Healthy Eating; Human; Incidence; Individual; Intake; Intervention; Iowa; Kansas; Life Style; Maintenance; Metabolism; Mission; Modification; Monitor; Nebraska; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Participant; Patient Recruitments; Personal Satisfaction; Physical activity; Population; Population Density; Prediabetes syndrome; Prevalence; Prevention; Prevention program; Procedures; Program Sustainability; Protocols documentation; Public Health; Randomized; Recommendation; Research; Research Project Grants; Research Support; Resources; Risk Factors; Rural; Schedule; Science; Services; Site; System; Techniques; Time; Training; Training Programs; Transportation; Travel; Universities; Weight; arm; compare effectiveness; comparison intervention; cost effective; diabetes prevention program; effectiveness evaluation; effectiveness outcome; efficacy outcomes; energy balance; implementation barriers; implementation facilitators; improved; intervention delivery; lifestyle intervention; low socioeconomic status; meetings; nutrition; online delivery; participant retention; patient engagement; programs; recruit; remote delivery; retention rate; rural area; rural counties; rural dwellers; therapy design; treatment arm; urban area

PROJECT 3 (GORCZYCA): PROJECT SUMMARY Diabetes disproportionately impacts the 60 million individuals (19.3% of the U.S. population) living in rural areas. The Center for Disease Control’s (CDC) National Diabetes Prevention Program (NDPP) which includes a minimum of 16 weekly core sessions over 6 mos. and 6 monthly maintenance sessions provides the framework for the prevention of type 2 diabetes (T2D) in the U.S. NDPP recognized programs are available in ~28% of U.S. counties; however, access to at least 1 NDPP recognized program is significantly lower in rural (2.6%) compared with urban areas (11.1%). Low population density and lack of financial resources represent significant barriers to the implementation and dissemination of the NDPP in rural areas. The Cooperative State Research, Education and Extension Service, a partnership between the U.S. Department of Agriculture, land-grant universities and county governments represents a potentially effective but underutilized site for delivery of NDPP to rural residents. However, evidence to support the effectiveness of the NDPP lifestyle intervention in rural adults with prediabetes defined by CDC criteria, with the intervention delivered by CES staff who have completed CDC approved training and using CDC recommendations for both program curriculum and meeting schedule is unavailable. The time and expense required to travel to attend traditional face-to-face (FTF) group sessions represents a significant barrier to participation in NDPP in adults living in rural areas. Distance learning, e.g. group video using Zoom® and online platforms such as Facebook® for delivery of NDPP are currently approved for CDC recognition. Remote delivery platforms provide a potentially cost-effective strategy for improving participation and retention, which are both important predictors of weight loss and reduced diabetes incidence in NDPP. Therefore, the proposed 12 mo., 3-arm cluster-randomized non-inferiority trial will compare the effectiveness of the NDPP protocol delivered via Zoom®, Facebook® or FTF at program completion (12 mos.). Kansas State University Research and Extension (KSRE) sites serving rural counties in Kansas (n= 3) will be randomized to deliver one of the 3 intervention arms. Each site will recruit 15 adults with prediabetes (NDPP criteria) living in the county served by the participating KSRE site. KSRE staff who will complete CDC-NDPP training will serve as lifestyle coaches. The primary aim will determine the effectiveness by comparing mean changes in body weight (kg/%), percent achieving ≥ 5% weight loss, PA (min/day)/percent achieving the 150min/wk. goal, energy/fat intake, and HbA1c at both 6 and 12 months across the 3 intervention arms. Additionally we will assess the feasibility of the intervention by comparing participant recruitment and retention rates, duration of program participation, session attendance, participant engagement with Facebook®, compliance with self-monitoring (diet, PA, weight), and the fidelity of intervention delivery across the 3 intervention arms.

项目3(戈尔奇卡)：项目总结 糖尿病对生活在农村地区的6000万人(占美国人口的19.3%)的影响不成比例。 疾病控制中心(CDC)的国家糖尿病预防计划(NDPP)包括 每周至少16次核心会议，为期6个月。每月6次的维护会议提供了框架 对于美国的2型糖尿病(T2D)的预防，NDPP认可的计划在约28%的地区可用 美国各县；然而，农村地区获得至少1个NDPP认可项目的机会明显较低(2.6%) 与城市地区(11.1%)相比。低人口密度和缺乏财政资源是重要的 在农村地区实施和传播国家发展伙伴关系的障碍。合作国研究组织， 教育和推广服务，美国农业部之间的合作伙伴关系，土地批出 大学和县政府是提供NDPP的潜在有效但未得到充分利用的场所 对农村居民来说。然而，支持NDPP生活方式干预在农村有效的证据 根据CDC标准定义的成人糖尿病前期，由CES工作人员完成干预 CDC批准的培训和使用CDC对计划课程和会议时间表的建议是 不可用。参加传统面对面(FTF)小组会议所需的时间和费用 对生活在农村地区的成年人来说，这是参与NDPP的一个重大障碍。远程学习，例如 使用Zoom®和Facebook®等在线平台交付NDPP的群组视频目前已获得批准 美国疾病控制与预防中心认可。远程交付平台提供了一种潜在的经济高效的改进策略 参与和保留，这都是减肥和降低糖尿病发病率的重要预测因素 在NDPP中。因此，拟议的12个月、3个臂的随机非劣势试验将比较 通过Zoom®、Facebook®或FTF在计划完成时交付的NDPP协议的有效性(12个月)。 堪萨斯州立大学研究和推广(KSRE)网站将为堪萨斯州农村县(n=3)提供服务 随机提供3个干预臂中的一个。每个站点将招募15名糖尿病前期(NDPP)成年人 条件)居住在参与KSRE站点所服务的县。将完成CDC-NDPP的KSRE工作人员 培训将作为生活方式教练。主要目的将通过比较平均水平来确定有效性 体重变化(公斤/%)，实现≥5%体重减轻的百分比，PA(分钟/天)/实现 150分钟/周。3个干预组6个月和12个月的目标、能量/脂肪摄入量和糖化血红蛋白。 此外，我们将通过比较参与者的招募和保留来评估干预的可行性 费率、参与计划的持续时间、课程出勤率、参与者对Facebook®的参与度、 遵守自我监控(饮食、PA、体重)，以及在3个月内实施干预的保真度 干预武器。