Stress Management Among Latinos with Type 2 Diabetes

描述（由申请人提供）：本研究的目的是评估哈特福德医院服务的拉丁裔2型糖尿病患者（T2D）的减压干预对以下方面的影响：a) HbA1c水平，b)通过血糖传感器和自动交互式语音应答系统（IVR）测量的应激反应性。为了获得200名完成研究的人，将从“Amigos en Salud”诊所招募250名患有T2D的拉丁美洲人。他们将被随机分配到：a)对照组，将接受3次由社区卫生工作者（CHW）领导的营养教育小组会议；b)干预组，另外将接受8次由训练有素的社区卫生工作者提供的压力管理干预。干预措施将以小组形式（每组12名成员）在西班牙裔保健理事会进行。干预的主要结果将是基线、干预后（入组后9周）和6个月的HbA1c测量。次要结果将是通过一个IVR系统测量压力反应，该系统包括插入一个代谢传感器，参与者将携带该传感器3天，并通过自动语音系统每天报告与压力相关的事件和应对情况，在同一时期和注册后6个月。子样本（n=75）将参与干预前/后进行的IVR和代谢传感器测量。所有研究参与者都将在家中接受一项基于电子平板电脑的调查，以评估心理健康、营养以及基本的社会经济和人口参数。在同一时间点，社区抽血师将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引导方法，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。

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.