Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes.
Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes.
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DOI：
10.2196/jmir.4897
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发表时间：
2015-10-23
影响因子：
7.4
通讯作者：
Block CH
中科院分区：
文献类型：
--
作者：
Block G;Azar KM;Romanelli RJ;Block TJ;Hopkins D;Carpenter HA;Dolginsky MS;Hudes ML;Palaniappan LP;Block CH
三分之一的美国成年人，8600万人，患有前驱糖尿病。三分之二的成年人超重或肥胖，有患糖尿病的风险。需要有效和负担得起的干预措施，以帮助这8600万人和其他高风险人群，以减少他们向诊断糖尿病的进展。其目的是评估通过Web、互联网、移动的电话和自动电话呼叫提供的全自动算法驱动的糖尿病预防行为干预（Alive-PD）的有效性。Alive-PD提供量身定制的行为支持，以改善身体活动，饮食习惯以及减肥，压力和睡眠等因素。每周电子邮件建议小步目标，并链接到个人网页，其中包含通过虚拟团队、竞争和健康信息进行跟踪、指导、社会支持的工具。一个移动的电话应用程序和自动电话呼叫提供了进一步的支持。该试验将339人随机分配到Alive-PD干预组（n=163）或6个月的等待名单常规护理对照组（n=176）。如果空腹血糖或糖化血红蛋白A1 c（HbA 1c）在糖尿病前期范围内，则参与者有资格参加。主要结局指标为6个月时空腹血糖和HbA 1c的变化。次要结局指标包括临床测量的体重、体重指数（BMI）、腰围、甘油三酯/高密度脂蛋白胆固醇（TG/HDL）比值和Fracket-Diabetes风险评分的变化。受试者的平均年龄为55岁（标准差8.9），平均BMI为31.2（标准差4.4）kg/m2，68.7%（233/339）为男性。平均空腹血糖在糖尿病前期范围内（平均值109.9，SD 8.4 mg/dL），而平均HbA 1c为5.6%（SD 0.3），在正常范围内。在意向治疗分析中，存活PD参与者的空腹血糖降低幅度显著大于对照组。（平均值-7.36 mg/dL，95% CI -7.85至-6.87 vs平均值-2.19，95% CI -2.64至-1.73，P<.001），HbA 1c（平均值-0.26%，95%CI-0.27至-0.24 vs平均值-0.18%，95%CI-0.19至-0.16，P <.001），体重（平均值-3.26 kg，95% CI -3.26至-3.25 vs平均值-1.26 kg，95% CI -1.27至-1.26，P<.001）。Alive-PD参与者的BMI、腰围和TG/HDL的降低幅度也显着大于对照组。在6个月时，Alive-PD组将他们的Fragrance 8年糖尿病风险从16%降至11%，显著高于对照组（P<.001）。参与和保留情况良好;干预参与者与该计划互动的中位数为24周的17（IQR 14），71.1%（116/163）在第6个月仍与该计划互动。Live-PD改善血糖控制、体重、BMI、腰围、TG/HDL比值和糖尿病风险。作为一个完全自动化的系统，该计划具有很高的可扩展性潜力，可以覆盖8600万美国成年人中的许多人，他们患有糖尿病前期以及其他高危人群。Clinicaltrials.gov NCT 01479062; https://clinicaltrials.gov/ct2/show/NCT01479062（由WebCite在http：//www.webcitation.org/6bt4V20NR上存档）
One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes. The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls. Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat. Participants’ mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m2, and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean –7.36 mg/dL, 95% CI –7.85 to –6.87 vs mean –2.19, 95% CI –2.64 to –1.73, P<.001), HbA1c (mean –0.26%, 95% CI –0.27 to –0.24 vs mean –0.18%, 95% CI –0.19 to –0.16, P<.001), and body weight (mean –3.26 kg, 95% CI –3.26 to –3.25 vs mean –1.26 kg, 95% CI –1.27 to –1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6. Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups. Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR)