Heisler Michele, Quiroga Grecia, Valbuena Felix, Resnicow Ken, Stoll Shelley, Griauzde Dina H, Hofer Timothy, Kullgren Jeffrey T
Department of Internal Medicine, University of Michigan Medical School, Building 16, North Campus Research Complex, 2800 Plymouth Road, Ann Arbor, MI 48109, USA; Institute for Healthcare Policy and Innovation, University of Michigan, Building 16, North Campus Research Complex, 2800 Plymouth Road, Ann Arbor, MI 48109, USA; Department of Health Behavior and Health Equity, School of Public Health, University of Michigan, 1420 Washington Heights, Ann Arbor, MI 48109, USA; Veterans Affairs Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Mail Stop 152, Ann Arbor, MI 48105, USA.
Department of Internal Medicine, University of Michigan Medical School, Building 16, North Campus Research Complex, 2800 Plymouth Road, Ann Arbor, MI 48109, USA.
Contemp Clin Trials. 2025 Aug;155:107971. doi: 10.1016/j.cct.2025.107971. Epub 2025 May 31.
Engagement in Diabetes Prevention Programs (DPPs) helps prevent or delay progression to type 2 diabetes, but engagement in these is low, especially among low-income and Black or Latina/o adults. While financial incentives can increase engagement, offering these is not feasible for safety net health systems. The INSPIRA Study is thus assessing the feasibility, acceptability, and preliminary effectiveness of a program that supplements a community health worker (CHW)-led DPP with mutual peer support and healthy food vouchers as incentives for engagement.
Single site pilot randomized trial.
A federally qualified health center that serves predominantly Latina/o adults.
142 adults with prediabetes and BMI ≥25 kg/m2.
Participants are randomized to either a 6-month version of a CHW-led DPP or to the INSPIRA intervention that supplements a six-month CHW-led DPP group with being matched with a peer partner in the same DPP cohort and the opportunity to earn weekly healthy food vouchers for attending that week's DPP session. Peer partners who both engage in at least one peer support call with each other and attend that week's session each earn double the amount in food vouchers ("yoked incentives").
Between-group differences in number of weekly sessions attended and changes in weight. Surveys and interviews will assess acceptability and feasibility. Changes in A1c, waist circumference, diet quality, and parameters for sample size calculations for a larger RCT will also be examined.
This pilot will inform a longer-term trial to evaluate both effectiveness and implementation of INSPIRA in clinical practice.
参与糖尿病预防计划(DPPs)有助于预防或延缓2型糖尿病的进展,但参与率较低,尤其是在低收入以及黑人或拉丁裔成年人中。虽然经济激励措施可以提高参与率,但对于安全网医疗系统而言,提供这些措施并不可行。因此,INSPIRA研究正在评估一项计划的可行性、可接受性和初步有效性,该计划以社区卫生工作者(CHW)主导的DPP为基础,辅以相互的同伴支持和健康食品代金券作为参与激励。
单中心试点随机试验。
一家主要为拉丁裔成年人服务的联邦合格健康中心。
142名患有糖尿病前期且体重指数≥25kg/m²的成年人。
参与者被随机分配到为期6个月的由CHW主导的DPP组,或INSPIRA干预组。INSPIRA干预组在为期6个月的由CHW主导的DPP组基础上,增加与同组的同伴配对,并有可能因参加当周的DPP课程而获得每周健康食品代金券。相互至少进行一次同伴支持通话并参加当周课程的同伴搭档每人可获得双倍数量的食品代金券(“捆绑激励”)。
两组之间每周参加课程的次数差异以及体重变化。调查和访谈将评估可接受性和可行性。还将检查糖化血红蛋白(A1c)、腰围、饮食质量的变化以及为更大规模随机对照试验进行样本量计算的参数。
该试点将为一项长期试验提供信息,以评估INSPIRA在临床实践中的有效性和实施情况。