Griauzde Dina H, Kullgren Jeffrey T, Liestenfeltz Brad, Richardson Caroline, Heisler Michele
1Robert Wood Johnson Foundation Clinical Scholars Program, University of Michigan, Ann Arbor, MI USA.
2VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 14, Room G100-36, Ann Arbor, MI 48109-2800 USA.
Pilot Feasibility Stud. 2018 Feb 13;4:48. doi: 10.1186/s40814-018-0246-z. eCollection 2018.
Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability.
This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience) as well as changes in psychosocial outcomes, hemoglobin A1c, and weight.
To our knowledge, this is the first study that aims to promote positive health behaviors among individuals with prediabetes who previously declined to participate in a DPP. Our results will inform a larger trial to test the effect of JOOL Health on clinically relevant outcomes, including weight loss, physical activity, and DPP engagement.
NCT03025607. Registered February 2017.
糖尿病预防项目（DPPs）的参与率较低。这可能部分归因于许多糖尿病前期个体预防2型糖尿病（T2DM）的自主动机水平较低（即源自内在因素并能长期维持健康行为的动机）。纳入自我决定理论原则的移动健康（mHealth）技术提供了一种有效且可扩展的方法来提高自主动机水平。一款很有前景的基于手机的应用程序是JOOL Health，其旨在帮助用户将某些健康行为（如睡眠和饮食）与特定生活领域（如家庭和工作）中的个人价值观联系起来。本研究的首要目标是评估JOOL Health能否提高那些拒绝参与DPP的糖尿病前期个体预防T2DM的自主动机。这项试点研究的第二个目标是检验该干预措施的可行性和可接受性。
这是一项为期12周的三臂试点随机对照试验。我们将招募105名糖尿病前期个体，尽管他们的健康计划邀请他们免费参加面对面或基于网络的项目，但他们仍未参与DPP。参与者将被随机分配到三个研究组之一：（1）一个接收有关糖尿病前期信息、降低进展为T2DM的循证策略以及一份用于监测饮食、身体活动和体重的mHealth工具资源清单的组（对照组）；（2）一个接收JOOL Health应用程序的组；（3）一个既接收JOOL Health应用程序又接收Fitbit活动追踪器和无线体重秤的组。我们的主要结局是预防T2DM的自主动机变化（使用治疗自我调节问卷进行测量）。我们还将收集与干预措施的可行性（招募和保留率）和可接受性（依从性和定性体验）以及心理社会结局、糖化血红蛋白和体重变化相关的数据。
据我们所知，这是第一项旨在促进先前拒绝参与DPP的糖尿病前期个体的积极健康行为的研究。我们的结果将为一项更大规模的试验提供信息，以测试JOOL Health对包括体重减轻、身体活动和参与DPP在内的临床相关结局的影响。
NCT03025607。于2017年2月注册。
