Department of Dietetics, National University Hospital, Singapore.
Faculty of Health Sciences, University of Adelaide, Australia.
JAMA Netw Open. 2021 Jun 1;4(6):e2112417. doi: 10.1001/jamanetworkopen.2021.12417.
IMPORTANCE: Lifestyle interventions are effective in diabetes management, with smartphone apps that manage health data and dietary and exercise schedules gaining popularity. However, limited evidence from randomized clinical trials exists regarding the effectiveness of smartphone-based interventions among Asian adults with type 2 diabetes. OBJECTIVE: To compare the effects of a culturally contextualized smartphone-based intervention with usual care on weight and metabolic outcomes. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial conducted at multiple primary care centers in Singapore included 305 adults with type 2 diabetes and body mass index (BMI) of 23 or greater who had literacy in English and smartphone access. Participants were recruited between October 3, 2017, and September 9, 2019, and were randomly assigned (1:1; stratified by gender, age, and BMI) to intervention (99 participants) or control (105 participants) groups. Participants' data were analyzed using intention-to-treat analysis. INTERVENTIONS: Both control and intervention participants received diet and physical activity advice from a dietitian at a baseline face-to-face visit. Intervention participants additionally used a smartphone app to track weight, diet, physical activity, and blood glucose and then communicated with dietitians for 6 months. MAIN OUTCOMES AND MEASURES: Primary outcome was change in body weight, while secondary outcomes were changes in hemoglobin A1c (HbA1c), fasting blood glucose, blood pressure, lipids, and diet. Post hoc analyses included glycemic changes in the subgroup with HbA1c levels of 8% or greater and diabetes medication changes. RESULTS: Among the 204 randomized participants (mean [SD] age, 51.2 [9.7] years; 132 [64.7%] men), baseline mean (SD) BMI was 30.6 (4.3). Compared with the control group, intervention participants achieved significantly greater reductions in weight (mean [SD] change, -3.6 [4.7] kg vs -1.2 [3.6] kg) and HbA1c levels (mean [SD] change, -0.7% [1.2] vs -0.3% [1.0]), with a greater proportion having a reduction in diabetes medications (17 participants [23.3%] vs 4 participants [5.4%]) at 6 months. The intervention led to a greater HbA1c reduction among participants with HbA1c levels of 8% or higher (mean [SD] change, -1.8% [1.4] vs -1.0% [1.4]; P = .001). Intergroup differences favoring the intervention were also noted for fasting blood glucose, diastolic blood pressure, and dietary changes. CONCLUSIONS AND RELEVANCE: In this study, a smartphone-based lifestyle intervention was more effective in achieving weight and glycemic reductions among Asian adults with type 2 diabetes compared with usual care, supporting the use of apps in lifestyle intervention delivery. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12617001112358.
重要性:生活方式干预在糖尿病管理中非常有效,而管理健康数据、饮食和运动计划的智能手机应用程序也越来越受欢迎。然而,关于基于智能手机的干预措施在亚洲 2 型糖尿病成人中的有效性,仅有有限的随机临床试验证据。
目的:比较基于文化背景的智能手机干预与常规护理对体重和代谢结果的影响。
设计、设置和参与者:这项在新加坡多个基层医疗中心进行的随机临床试验纳入了 305 名患有 2 型糖尿病且 BMI 为 23 或以上、具有英语读写能力且能够使用智能手机的成年人。参与者于 2017 年 10 月 3 日至 2019 年 9 月 9 日期间被招募,并按 1:1 比例(按性别、年龄和 BMI 分层)随机分配到干预组(99 名参与者)或对照组(105 名参与者)。采用意向治疗分析对参与者的数据进行分析。
干预措施:控制组和干预组的参与者都在基线面对面就诊时接受了营养师的饮食和身体活动建议。干预组的参与者还使用智能手机应用程序来跟踪体重、饮食、身体活动和血糖,然后与营养师沟通 6 个月。
主要结局和测量指标:主要结局是体重变化,次要结局是糖化血红蛋白(HbA1c)、空腹血糖、血压、血脂和饮食的变化。事后分析包括 HbA1c 水平为 8%或更高的亚组的血糖变化和糖尿病药物变化。
结果:在 204 名随机参与者中(平均[标准差]年龄 51.2[9.7]岁;132[64.7%]名男性),基线平均(标准差)BMI 为 30.6(4.3)。与对照组相比,干预组参与者体重显著减轻(平均[标准差]变化量,-3.6[4.7]kg 与-1.2[3.6]kg),HbA1c 水平也显著降低(平均[标准差]变化量,-0.7%[1.2]与-0.3%[1.0]),且在 6 个月时,有更多参与者减少了糖尿病药物的使用(17 名[23.3%]与 4 名[5.4%])。干预组还能更显著地降低 HbA1c 水平在 8%或更高的参与者中(平均[标准差]变化量,-1.8%[1.4]与-1.0%[1.4];P=0.001)。干预组在空腹血糖、舒张压和饮食变化方面也显示出优于对照组的组间差异。
结论和相关性:在这项研究中,与常规护理相比,基于智能手机的生活方式干预在亚洲 2 型糖尿病成人中更有效地实现了体重和血糖的降低,支持在生活方式干预中使用应用程序。
试验注册:anzctr.org.au 标识符:ACTRN12617001112358。
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