Ruiz-Leon Ana Maria, Casas Rosa, Castro-Barquero Sara, Alfaro-González Sofia, Radeva Petia, Sacanella Emilio, Casanovas-Garriga Francesc, Pérez-Gesalí Ainhoa, Estruch Ramon
Department of Internal Medicine, Hospital Clinic, Institut d'Investigacio Biomèdica August Pi i Sunyer, Barcelona, Spain.
CIBERobn Fisiopatología de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain.
J Med Internet Res. 2025 Jan 22;27:e58319. doi: 10.2196/58319.
Enhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care.
This study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care.
A 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. Participants were recruited face-to-face from primary care centers in Barcelona, Spain, between July 2021 and March 2022. They were randomly assigned to 1 of 2 groups: (1) an intervention group (n=61) instructed to use the Greenhabit mobile app alongside standard care, or (2) a control group (n=62) who received advice on maintaining a healthy diet and followed standard care. The Greenhabit app incorporates serious gaming technology. Participants received daily messages and challenges focused on promoting a healthy lifestyle, including nutrition, exercise, relaxation, a positive mindset, and a supportive social environment. The app encouraged participants to set weekly goals and awarded points for completing challenges. Data on nutrition, anthropometrics, and blood and urine samples were collected at baseline, 6 weeks, and 12 weeks. Questionnaires assessing quality of life, work-life balance, and social environment were administered at baseline and during the final visit. The primary outcomes were HbA1c and fasting plasma glucose (FPG). Repeated-measures analysis of variance was used to compare changes over time (baseline to 6 weeks and baseline to 12 weeks) between the 2 intervention groups. Analysis of covariance was performed to evaluate changes at 6 and 12 weeks, adjusted for baseline levels of each variable. Multiple contrasts were corrected using a Bonferroni post hoc test.
Both groups showed significant reductions in HbA1c after 6 and 12 weeks (mean change in the intervention group [n=50] -0.4%, P<.001 vs -0.3% in the control group [n=53], P=.001) and in FPG after 6 weeks (mean change in the intervention group -5.3 mg/dL, P=.01 vs control group -5.8 mg/dL, P=.01). At 12 weeks, the intervention group also showed significant reductions in systolic and diastolic blood pressures (mean change -4.5, P=.049 and -2.4 mmHg, P=.03, respectively), body weight (mean change -0.8 kg, P=.03), BMI (mean change -0.3 kg/m2, P=.03), waist circumference (mean change -1.0 cm, P=.046), and triglyceride concentration (mean change -20.0 mg/dL, P=.03). There was also a significant increase in high-density lipoprotein-cholesterol concentrations (mean change 2 mg/dL, P=.049). Finally, improvements were noted in 3 out of the 5 elements of balance: positivity, social environment, and work-life balance.
The 12-week intervention with the Greenhabit behavioral treatment mHealth app showed beneficial effects on T2D outcomes and reduced the burden of cardiovascular risk factors. Although larger studies are warranted, these results suggest that mHealth apps can be a promising tool for improving T2D self-management.
ISRCTN Registry ISRCTN13456652; http://www.isrctn.com/ISRCTN13456652.
通过数字工具加强医疗保健中的自我管理是一种很有前景的策略，可使2型糖尿病（T2D）患者有能力改善自我护理。
本研究评估与标准护理相比，Greenhabit（移动健康[mHealth]）行为治疗是否能改善T2D的治疗效果。
对123名最近被诊断为T2D的参与者（62/123，50%为女性；平均年龄58.25岁，标准差9.46岁）进行了一项为期12周的平行、单盲随机对照试验。2021年7月至2022年3月期间，在西班牙巴塞罗那的初级保健中心面对面招募参与者。他们被随机分为两组中的一组：（1）干预组（n = 61），在接受标准护理的同时被指示使用Greenhabit移动应用程序；（2）对照组（n = 62），接受关于保持健康饮食的建议并遵循标准护理。Greenhabit应用程序采用了严肃游戏技术。参与者每天收到专注于促进健康生活方式的信息和挑战，包括营养、运动、放松、积极心态和支持性的社会环境。该应用程序鼓励参与者设定每周目标，并为完成挑战奖励积分。在基线、6周和12周时收集营养、人体测量学以及血液和尿液样本的数据。在基线和最后一次访视期间发放评估生活质量、工作与生活平衡以及社会环境的问卷。主要结局指标为糖化血红蛋白（HbA1c）和空腹血糖（FPG）。采用重复测量方差分析比较两组干预组随时间（基线至6周和基线至12周）的变化。进行协方差分析以评估6周和12周时的变化，并对每个变量的基线水平进行校正。使用Bonferroni事后检验校正多重对比。
两组在6周和12周后HbA1c均显著降低（干预组[n = 50]平均变化-0.4%，P <.001，对照组[n = 53]为-0.3%，P =.001），6周后FPG也显著降低（干预组平均变化-5.3 mg/dL，P =.01，对照组为-5.8 mg/dL，P =.01）。在12周时，干预组的收缩压和舒张压也显著降低（平均变化分别为-4.5，P =.049和-2.4 mmHg，P =.03），体重（平均变化-0.8 kg，P =.03），体重指数（BMI）（平均变化-0.3 kg/m²，P =.03），腰围（平均变化-1.0 cm，P =.046）和甘油三酯浓度（平均变化-20.0 mg/dL，P =.03）。高密度脂蛋白胆固醇浓度也显著升高（平均变化2 mg/dL，P =.049）。最后，在平衡的5个要素中的3个方面有改善：积极性、社会环境和工作与生活平衡。
使用Greenhabit行为治疗mHealth应用程序进行的12周干预对T2D治疗效果有有益影响，并减轻了心血管危险因素的负担。尽管需要更大规模的研究，但这些结果表明mHealth应用程序可能是改善T2D自我管理的一个有前景的工具。
ISRCTN注册库ISRCTN13456652；http://www.isrctn.com/ISRCTN13456652 。
