We investigated the effects of a physical activity encouragement intervention based on a smartphone personal health record (PHR) application (app) on step count increases, glycemic control, and body weight in patients with type 2 diabetes (T2D). In this 12-week, single-center, randomized controlled, 12-week extension study, patients with T2D who were overweight or obese were randomized using ratio 1:2 to a group using a smartphone PHR app (control group) or group using the app and received individualized motivational text messages (intervention group) for 12 weeks. During the extension period, the sending of the encouraging text messages to the intervention group was discontinued. The primary outcome was a change in daily step count after 12 weeks and analyzed by independent t-test. The secondary outcomes included HbA1c, fasting glucose, and body weight analyzed by paired or independent t-test. Of 200 participants, 62 (93.9%) and 118 (88.1%) in the control and intervention group, respectively, completed the 12-week main study. The change in daily step count from baseline to week 12 was not significantly different between the two groups (P = 0.365). Among participants with baseline step counts < 7,500 steps per day, the change in the mean daily step count at week 12 in the intervention group (1,319 ± 3,020) was significantly larger than that in control group (-139 ± 2,309) (P = 0.009). At week 12, HbA1c in the intervention group (6.7 ± 0.5%) was significantly lower than that in control group (6.9 ± 0.6%, P = 0.041) and at week 24, changes in HbA1c from baseline were significant in both groups but, comparable between groups. Decrease in HbA1c from baseline to week 12 of intervention group was greater in participants with baseline HbA1c ≥ 7.5% (-0.81 ± 0.84%) compared with those with baseline HbA1c < 7.5% (-0.22 ± 0.39%) (P for interaction = 0.014). A significant reduction in body weight from baseline to week 24 was observed in both groups without significant between-group differences (P = 0.370). App-based individualized motivational intervention for physical activity did not increase daily step count from baseline to week 12, and the changes in HbA1c levels from baseline to week 12 were comparable. ClinicalTrials.gov (NCT03407222).

中文翻译：

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一项基于应用程序干预 2 型糖尿病患者体力活动和血糖控制的随机对照试验

我们研究了基于智能手机个人健康记录 (PHR) 应用程序 (app) 的体育活动鼓励干预措施对 2 型糖尿病 (T2D) 患者步数增加、血糖控制和体重的影响。在这项为期 12 周、单中心、随机对照、为期 12 周的延伸研究中，超重或肥胖的 2 型糖尿病患者按照 1:2 的比例被随机分配到使用智能手机 PHR 应用程序的组（对照组）或使用应用程序并收到个性化的激励短信（干预组），为期 12 周。在延长期内，停止向干预组发送鼓励短信。主要结果是 12 周后每日步数的变化，并通过独立 t 检验进行分析。次要结果包括通过配对或独立 t 检验分析的 HbA1c、空腹血糖和体重。在 200 名参与者中，对照组和干预组分别有 62 名 (93.9%) 和 118 名 (88.1%) 完成了为期 12 周的主要研究。两组之间每日步数从基线到第 12 周的变化没有显着差异 (P = 0.365)。在基线步数每天 < 7,500 步的参与者中，干预组第 12 周的平均每日步数变化 (1,319 ± 3,020) 显着大于对照组 (-139 ± 2,309) (P = 0.009 ）。第 12 周时，干预组的 HbA1c (6.7 ± 0.5%) 显着低于对照组 (6.9 ± 0.6%，P = 0.041)，并且在第 24 周时，两组的 HbA1c 相对于基线的变化均显着，但是，组间具有可比性。与基线 HbA1c < 7.5% (-0.22 ± 0.39%) 的参与者相比，基线 HbA1c ≥ 7.5% (-0.81 ± 0.84%) 的参与者的 HbA1c 从基线到干预组第 12 周的下降幅度更大（交互作用 P = 0.014） ）。从基线到第 24 周，两组的体重均显着下降，但组间差异不显着 (P = 0.370)。从基线到第 12 周，基于应用程序的个性化体力活动动机干预并未增加每日步数，并且从基线到第 12 周的 HbA1c 水平变化具有可比性。 ClinicalTrials.gov (NCT03407222)。