Stress Management Among Latinos with Type 2 Diabetes

描述（由申请方提供）：本研究的目的是评估在Hartford医院服务的2型糖尿病（T2D）拉美裔患者中进行减压干预对以下方面的影响：a）HbA1c水平，和B）通过血糖传感器和自动交互式语音应答系统（IVR）测量的应激反应。为了获得200名研究完成者，将从“Amigos en Salud”诊所招募250名T2D拉丁裔患者。他们将被随机分配到：a）对照组，将接受3次社区卫生工作者（CHW）领导的营养教育小组课程，或B）干预组，此外将接受由经过培训的CHW提供的8次压力管理干预。干预将在西班牙裔健康理事会以小组形式进行（每组12名成员）。干预的主要结局将是基线、干预后（入组后9周）和6个月时测量的HbA1c。次要结局将是通过IVR系统测量的压力反应性，该系统涉及插入参与者将携带3天的代谢传感器，以及通过自动语音系统每日报告压力相关事件和在同一时间段内和入组后6个月的应对。子样本（n=75）将参与干预前后进行的IVR和代谢传感器测量。所有研究参与者将在家中进行基于电子平板电脑的调查，以评估心理健康，营养和基本的社会经济和人口统计参数。将由社区采血师在同一时间点在参与者家中采集血样。从这项随机试验中获得的知识可能会导致一种高度创新的CHW主导的方法，以改善生活在非常紧张的社会经济环境中的T2D患者的生活质量。 公共卫生相关性：没有发表的研究检查压力管理对2型糖尿病（T2D）拉丁美洲人代谢控制的影响。从这项随机试验中获得的知识可能会导致一种高度创新的社区卫生工作者主导的方法，以改善生活在非常紧张的社会经济环境下的T2D患者的生活质量。

DESCRIPTION (provided by applicant): The objectives of this study are to assess the impact of a stress reduction intervention among Latinos with Type 2 Diabetes (T2D) served by Hartford Hospital on: a) HbA1c levels, and b) stress reactivity measured through a blood glucose sensor and an automated Interactive Voice Response System (IVR). To obtain 200 study completers, 250 Latinos with T2D will be recruited from the 'Amigos en Salud' clinic. They will be randomly assigned to either: a) the control group that will receive 3 community health worker (CHW) led nutrition educational group sessions, or b) the intervention group that in addition will receive an 8-session stress management intervention delivered by a trained CHW. Intervention will be delivered at the Hispanic Health Council in a group format (12 members per group). The primary outcome of the intervention will be HbA1c measured at baseline, post-intervention (9 weeks post-enrollment) and 6 months. The secondary outcome will be stress reactivity measured through an IVR system that involves inserting a metabolic sensor that participants will carry for 3 days as well as daily reporting, via an automated voice system, of stress related events and coping during the same period of time and 6 month s post-enrollment. A subsample (n=75) will participate in the IVR and metabolic sensor measurements conducted pre/post intervention. All study participants will be applied an e-tablet based survey in their homes to assess mental health, nutrition and basic socio-economic and demographic parameters. Blood samples will be collected by a community phlebotomist in the participants' homes at the same time points. Knowledge gained from this randomized trial could lead to a highly innovative CHW led approach to improving the quality of life among individuals with T2D living in very stressful socio-economic environments. PUBLIC HEALTH RELEVANCE: There are no published studies examining the impact of stress management on metabolic control among Latinos with type 2 diabetes (T2D). Knowledge gained from this randomized trial could lead to a highly innovative community health worker led approach to improving the quality of life among individuals with T2D living under very stressful socio-economic environments.