A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol
A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol
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DOI：
10.2196/resprot.4046
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发表时间：
2015-01-01
影响因子：
1.7
通讯作者：
Block, Clifford H.
中科院分区：
文献类型：
--
作者：
Block, Gladys;Azar, Kristen M. J.;Block, Clifford H.
背景：在美国，8600 万成年人患有糖尿病前期。预防糖尿病需要具有成本效益且可广泛扩展的循证干预措施。目的：我们的目标是开发全自动糖尿病预防计划，并在随机对照试验中确定其有效性。方法：招募经证实患有糖尿病前期的受试者参加 Alive-PD 有效性试验，Alive-PD 是一项新开发的、为期 1 年的全自动行为改变计划，通过电子邮件和网络提供。该计划包括每周量身定制的目标设定、基于团队和个人的挑战、游戏化以及其他互动机会。随附的手机应用程序支持目标设定和活动规划。在该试验中，参与者通过计算机算法随机开始该计划，或在延迟 6 个月后开始该计划。主要结局指标是 HbA1c 和空腹血糖从基线到 6 个月的变化。次要结果指标是 3、6、9 和 12 个月时的 HbA1c、血糖、血脂、体重指数 (BMI)、体重、腰围和血压的变化。干预措施的随机化和实施独立于临床工作人员，他们对治疗分配不知情。将对意向治疗人群和符合方案人群的结果进行评估。结果：共有 340 名糖尿病前期受试者被随机分为干预组 (n=164) 或延迟进入对照组 (n=176)。基线特征如下：平均年龄 55 岁（SD 8.9）；平均体重指数 31.1 (SD 4.3)；男性 68.5%；平均空腹血糖 109.9 (SD 8.4) mg/dL；平均 HbA1c 5.6 (SD 0.3)%。数据收集和分析正在进行中。我们假设，在基线后 6 个月，与对照组相比，干预组参与者的空腹血糖和糖化血红蛋白 (HbA1c) 将实现统计上显着的降低。结论：随机试验将提供严格的证据，证明该基于网络和互联网的计划在减少或预防血糖标志物进展以及间接预防糖尿病进展方面的功效。
Background: In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes.Objective: Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial.Methods: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations.Results: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline.Conclusions: The randomized trial will provide rigorous evidence regarding the efficacy of this Web-and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes.