一种针对成人糖尿病前期患者的全自动、个性化健康指导的新方法：试点临床试验。
A Novel Approach for Fully Automated, Personalized Health Coaching for Adults with Prediabetes: Pilot Clinical Trial.
作者信息
Everett Estelle, Kane Brian, Yoo Ashley, Dobs Adrian, Mathioudakis Nestoras
机构信息
Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Reading Health Physician Network, Reading, PA, United States.
出版信息
J Med Internet Res. 2018 Feb 27;20(2):e72. doi: 10.2196/jmir.9723.
BACKGROUND
Prediabetes is a high-risk state for the future development of type 2 diabetes, which may be prevented through physical activity (PA), adherence to a healthy diet, and weight loss. Mobile health (mHealth) technology is a practical and cost-effective method of delivering diabetes prevention programs in a real-world setting. Sweetch (Sweetch Health, Ltd) is a fully automated, personalized mHealth platform designed to promote adherence to PA and weight reduction in people with prediabetes.
OBJECTIVE
The objective of this pilot study was to calibrate the Sweetch app and determine the feasibility, acceptability, safety, and effectiveness of the Sweetch app in combination with a digital body weight scale (DBWS) in adults with prediabetes.
METHODS
This was a 3-month prospective, single-arm, observational study of adults with a diagnosis of prediabetes and body mass index (BMI) between 24 kg/m and 40 kg/m. Feasibility was assessed by study retention. Acceptability of the mobile platform and DBWS were evaluated using validated questionnaires. Effectiveness measures included change in PA, weight, BMI, glycated hemoglobin (HbA), and fasting blood glucose from baseline to 3-month visit. The significance of changes in outcome measures was evaluated using paired t test or Wilcoxon matched pairs test.
RESULTS
The study retention rate was 47 out of 55 (86%) participants. There was a high degree of acceptability of the Sweetch app, with a median (interquartile range [IQR]) score of 78% (73%-80%) out of 100% on the validated System Usability Scale. Satisfaction regarding the DBWS was also high, with median (IQR) score of 93% (83%-100%). PA increased by 2.8 metabolic equivalent of task (MET)-hours per week (SD 6.8; P=.02), with mean weight loss of 1.6 kg (SD 2.5; P<.001) from baseline. The median change in A was -0.1% (IQR -0.2% to 0.1%; P=.04), with no significant change in fasting blood glucose (-1 mg/dL; P=.59). There were no adverse events reported.
CONCLUSIONS
The Sweetch mobile intervention program is a safe and effective method of increasing PA and reducing weight and HbA in adults with prediabetes. If sustained over a longer period, this intervention would be expected to reduce diabetes risk in this population.
TRIAL REGISTRATION
ClincialTrials.gov NCT02896010; https://clinicaltrials.gov/ct2/show/NCT02896010 (Archived by WebCite at http://www.webcitation.org/6xJYxrgse).
背景
糖尿病前期是2型糖尿病未来发展的高危状态，可通过体育活动（PA）、坚持健康饮食和体重减轻来预防。移动健康（mHealth）技术是在现实环境中提供糖尿病预防项目的一种实用且具成本效益的方法。Sweetch（Sweetch Health有限公司）是一个完全自动化的个性化mHealth平台，旨在促进糖尿病前期患者坚持体育活动并减轻体重。
目的
本试点研究的目的是校准Sweetch应用程序，并确定Sweetch应用程序与数字体重秤（DBWS）相结合在糖尿病前期成年人中的可行性、可接受性、安全性和有效性。
方法
这是一项为期3个月的前瞻性单臂观察性研究，对象为诊断为糖尿病前期且体重指数（BMI）在24 kg/m至40 kg/m之间的成年人。通过研究保留率评估可行性。使用经过验证的问卷评估移动平台和DBWS的可接受性。有效性指标包括从基线到3个月随访时PA、体重、BMI、糖化血红蛋白（HbA）和空腹血糖的变化。使用配对t检验或Wilcoxon配对检验评估结果指标变化的显著性。
结果
55名参与者中有47名（86%）完成了研究。Sweetch应用程序具有高度可接受性，在经过验证的系统可用性量表上的中位数（四分位间距[IQR]）得分为78%（73%-80%）（满分100%）。对DBWS的满意度也很高，中位数（IQR）得分为93%（83%-100%）。PA每周增加2.8代谢当量任务（MET）小时（标准差6.8；P=0.02），自基线起平均体重减轻1.6 kg（标准差2.5；P<0.001）。HbA的中位数变化为-0.1%（IQR -0.2%至0.1%；P=0.04），空腹血糖无显著变化（-1 mg/dL；P=0.59）。未报告不良事件。
结论
Sweetch移动干预项目是增加糖尿病前期成年人的体育活动、减轻体重和降低HbA的一种安全有效的方法。如果在更长时间内持续进行，预计该干预措施将降低该人群患糖尿病的风险。
试验注册
ClinicalTrials.gov NCT02896010；https://clinicaltrials.gov/ct2/show/NCT02896010（由WebCite存档于http://www.webcitation.org/6xJYxrgse）
Zotero 插件