Cui Jian, Liu Qiang, Huang Lihua, Yu Haoyan
Department of Physical Education, China University of Geosciences (Beijing), Beijing, China.
Department of Rehabilitation, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Front Endocrinol (Lausanne). 2025 Jul 31;16:1654129. doi: 10.3389/fendo.2025.1654129. eCollection 2025.
Obesity and physical inactivity exacerbate type 2 diabetes mellitus (T2DM), whereas regular exercise improves glycemic control, fitness, and quality of life. However, many patients face barriers to attending clinic-based exercise programs. Digital health interventions could increase access and adherence by enabling guided outdoor exercise via smartphone. It remains unclear if a digital program can achieve outcomes comparable to traditional supervised exercise in obese adults with T2DM.
We aimed to evaluate the noninferiority of a 12-week digital outdoor exercise program, delivered via mobile app, compared to a standard clinic-based exercise intervention in obese adults with T2DM. The primary outcome was the change in glycated hemoglobin (HbA1c). Secondary outcomes included changes in body mass index (BMI), physical fitness, and quality of life. Adherence and cost-effectiveness were also assessed.
We conducted a randomized controlled noninferiority trial at a single tertiary center. A total of 240 obese adults with T2DM were randomly assigned to either the digital outdoor exercise program (DOE) or a clinic-based exercise program (CBE). The digital intervention provided personalized aerobic and resistance exercise routines via a smartphone app with remote coaching, while the clinic group attended on-site supervised exercise sessions of similar frequency and intensity. Outcomes were measured at baseline and 12 weeks. The noninferiority margin for HbA1c was set at 0.4%. Analyses were performed on an intention-to-treat basis.
A total of 240 obese adults with T2DM were randomized equally into DOE and CBE groups. After 24 weeks, both groups achieved significant, comparable reductions in HbA1c (DOE: -1.56 ± 0.17%, CBE: -1.50 ± 0.17%), BMI, waist circumference, and improved physical fitness, with no significant between-group differences. The DOE intervention demonstrated significantly lower costs (14,787.30 CNY) compared to CBE (17,920.05 CNY; p<0.001). Adherence was high in both groups, with similarly low adverse event rates.
The 12-week smartphone-based outdoor exercise program was noninferior to a clinic-based program in improving HbA1c and BMI, and it produced similar gains in fitness and quality of life in obese adults with T2DM. Higher adherence in the digital intervention and its lower delivery cost indicate that digital exercise programs can be a cost-effective, scalable alternative to clinic-based interventions for managing T2DM.
https://www.chictr.org.cn/, identifier ChiCTR2500104389.
肥胖和缺乏身体活动会加重2型糖尿病（T2DM），而规律运动可改善血糖控制、健康状况和生活质量。然而，许多患者在参加基于诊所的运动项目时面临障碍。数字健康干预措施可通过智能手机实现户外有指导的运动，从而增加参与度和依从性。对于患有T2DM的肥胖成年人，数字项目能否取得与传统监督运动相当的效果仍不明确。
我们旨在评估通过移动应用程序提供的为期12周的数字户外运动项目与针对患有T2DM的肥胖成年人的标准基于诊所的运动干预相比的非劣效性。主要结局是糖化血红蛋白（HbA1c）的变化。次要结局包括体重指数（BMI）、体能和生活质量的变化。还评估了依从性和成本效益。
我们在一个单一的三级中心进行了一项随机对照非劣效性试验。总共240名患有T2DM的肥胖成年人被随机分配到数字户外运动项目（DOE）或基于诊所的运动项目（CBE）。数字干预通过智能手机应用程序提供个性化的有氧和阻力运动常规，并提供远程指导，而诊所组参加频率和强度相似的现场监督运动课程。在基线和12周时测量结局。HbA1c的非劣效性界值设定为0.4%。分析基于意向性分析。
总共240名患有T2DM的肥胖成年人被平均随机分为DOE组和CBE组。24周后，两组的HbA1c（DOE：-1.56±0.17%，CBE：-1.50±0.17%）、BMI、腰围均显著降低且相当，体能也有所改善，组间无显著差异。与CBE（17,920.05元人民币）相比，DOE干预的成本显著更低（14,787.30元人民币；p<0.001）。两组的依从性都很高，不良事件发生率同样较低。
在改善HbA1c和BMI方面，为期12周的基于智能手机的户外运动项目不劣于基于诊所的项目，并且在患有T2DM的肥胖成年人中，该项目在体能和生活质量方面也取得了类似的改善。数字干预的依从性更高且成本更低，这表明数字运动项目对于管理T2DM而言，可以成为一种具有成本效益且可扩展的替代基于诊所的干预措施。
