Pei-Zhen Zhang, Dan Guo, Chang-Qin Liu, Ning Chen, Jian-Fang Liu, Xu-Zhen Lei, Lin-Jie Yang, Ya-Ting Liu, Xu Li, Jun-Feng Huang, Chun-Min Du, Kai Wang, Wei Mo, Jia-Yang Lin, Chen-Si-Han Huang, Bing-Yan Xu, Xue-Yun Wei, De-Ying Liu, Jun-Lin Huang, Yan Huang, Yao-Ming Xue, Yan-Mei Zeng, Shi-Qun Liu, Zhi-Min Ma, Hui-Jie Zhang
{"title":"基于移动应用程序的干预与未控制的2型糖尿病患者心血管危险因素：一项随机临床试验","authors":"Pei-Zhen Zhang, Dan Guo, Chang-Qin Liu, Ning Chen, Jian-Fang Liu, Xu-Zhen Lei, Lin-Jie Yang, Ya-Ting Liu, Xu Li, Jun-Feng Huang, Chun-Min Du, Kai Wang, Wei Mo, Jia-Yang Lin, Chen-Si-Han Huang, Bing-Yan Xu, Xue-Yun Wei, De-Ying Liu, Jun-Lin Huang, Yan Huang, Yao-Ming Xue, Yan-Mei Zeng, Shi-Qun Liu, Zhi-Min Ma, Hui-Jie Zhang","doi":"10.1001/jamanetworkopen.2025.29762","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Controlling modifiable cardiovascular risk factors is important but underused for patients with type 2 diabetes (T2D). Mobile message-based intervention strategies could address this gap but lack evidence of benefit on multiple risk factors.</p><p><strong>Objective: </strong>To evaluate the effectiveness of a mobile message-based intervention in controlling cardiovascular risk factors in patients with T2D.</p><p><strong>Design, setting, and participants: </strong>In this randomized clinical trial, adults with uncontrolled T2D comorbid with cardiovascular disease (CVD) risk factors were recruited from 5 clinical centers in China. Data were collected from November 2018 to March 2022 and analyzed from January to June 2023.</p><p><strong>Intervention: </strong>Participants were randomized to receive either usual care or a mobile message-based intervention of 6 text messages per week from different modules designed to remind, encourage, and motivate them to participate in the behaviors needed for improving glycemic control and CVD risk factor management for 12 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome included mean changes in hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP) levels across 12 months. The secondary outcomes included the percentage of participants with controlled HbA1c at 12 months. Data were analyzed using the intention-to-treat principle.</p><p><strong>Results: </strong>A total of 819 participants (552 men [67.4%]; mean [SD] age, 50.1 [11.9] years; mean [SD] HbA1c level, 10.2% [2.1%]) were enrolled, of whom 410 were randomized to the intervention group and 409 to the control group. During the 12-month intervention, significant reductions in the mobile message-based intervention group were observed for HbA1c levels by -2.8% (95% CI, -2.9% to -2.6%), LDL-C by -11.1 mg/dL (95% CI, -14.7 to -7.4 mg/dL), and SBP by -2.5 mm Hg (95% CI, -3.9 to -1.2 mm Hg), and in the usual care group, by -2.5% (95% CI, -2.7% to -2.3%) for HbA1c, -11.9 mg/dL (95% CI, -15.8 to -8.0 mg/dL) for LDL-C, and -0.1 mm Hg (95% CI, -1.6 to 1.3 mm Hg) for SBP. The net group differences were -0.3% (95% CI, -0.5% to -0.0%) for HbA1c, 0.9 mg/dL (95% CI, -4.5 to 6.2 mg/dL) for LDL-C, and -2.4 mm Hg (95% CI, -4.3 to -0.4 mm Hg) for SBP (P = .001 for the combined overall effect). The percentage of participants with controlled HbA1c among all participants was significantly higher in the intervention group than in the control group at 12 months (195 participants [54.0%] vs 146 participants [46.1%]; P = .04).</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial of adults with uncontrolled T2D in China, a mobile message-based intervention resulted in a modest improvement in HbA1c and SBP in patients with diabetes compared with usual care. These results suggest that mobile message-based strategies for improving glycemic control and CVD risk factors should be considered for adults with T2D.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03724526.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 9","pages":"e2529762"},"PeriodicalIF":9.7000,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406060/pdf/","citationCount":"0","resultStr":"{\"title\":\"Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial.\",\"authors\":\"Pei-Zhen Zhang, Dan Guo, Chang-Qin Liu, Ning Chen, Jian-Fang Liu, Xu-Zhen Lei, Lin-Jie Yang, Ya-Ting Liu, Xu Li, Jun-Feng Huang, Chun-Min Du, Kai Wang, Wei Mo, Jia-Yang Lin, Chen-Si-Han Huang, Bing-Yan Xu, Xue-Yun Wei, De-Ying Liu, Jun-Lin Huang, Yan Huang, Yao-Ming Xue, Yan-Mei Zeng, Shi-Qun Liu, Zhi-Min Ma, Hui-Jie Zhang\",\"doi\":\"10.1001/jamanetworkopen.2025.29762\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Controlling modifiable cardiovascular risk factors is important but underused for patients with type 2 diabetes (T2D). Mobile message-based intervention strategies could address this gap but lack evidence of benefit on multiple risk factors.</p><p><strong>Objective: </strong>To evaluate the effectiveness of a mobile message-based intervention in controlling cardiovascular risk factors in patients with T2D.</p><p><strong>Design, setting, and participants: </strong>In this randomized clinical trial, adults with uncontrolled T2D comorbid with cardiovascular disease (CVD) risk factors were recruited from 5 clinical centers in China. Data were collected from November 2018 to March 2022 and analyzed from January to June 2023.</p><p><strong>Intervention: </strong>Participants were randomized to receive either usual care or a mobile message-based intervention of 6 text messages per week from different modules designed to remind, encourage, and motivate them to participate in the behaviors needed for improving glycemic control and CVD risk factor management for 12 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome included mean changes in hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP) levels across 12 months. The secondary outcomes included the percentage of participants with controlled HbA1c at 12 months. Data were analyzed using the intention-to-treat principle.</p><p><strong>Results: </strong>A total of 819 participants (552 men [67.4%]; mean [SD] age, 50.1 [11.9] years; mean [SD] HbA1c level, 10.2% [2.1%]) were enrolled, of whom 410 were randomized to the intervention group and 409 to the control group. During the 12-month intervention, significant reductions in the mobile message-based intervention group were observed for HbA1c levels by -2.8% (95% CI, -2.9% to -2.6%), LDL-C by -11.1 mg/dL (95% CI, -14.7 to -7.4 mg/dL), and SBP by -2.5 mm Hg (95% CI, -3.9 to -1.2 mm Hg), and in the usual care group, by -2.5% (95% CI, -2.7% to -2.3%) for HbA1c, -11.9 mg/dL (95% CI, -15.8 to -8.0 mg/dL) for LDL-C, and -0.1 mm Hg (95% CI, -1.6 to 1.3 mm Hg) for SBP. The net group differences were -0.3% (95% CI, -0.5% to -0.0%) for HbA1c, 0.9 mg/dL (95% CI, -4.5 to 6.2 mg/dL) for LDL-C, and -2.4 mm Hg (95% CI, -4.3 to -0.4 mm Hg) for SBP (P = .001 for the combined overall effect). The percentage of participants with controlled HbA1c among all participants was significantly higher in the intervention group than in the control group at 12 months (195 participants [54.0%] vs 146 participants [46.1%]; P = .04).</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial of adults with uncontrolled T2D in China, a mobile message-based intervention resulted in a modest improvement in HbA1c and SBP in patients with diabetes compared with usual care. These results suggest that mobile message-based strategies for improving glycemic control and CVD risk factors should be considered for adults with T2D.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03724526.</p>\",\"PeriodicalId\":14694,\"journal\":{\"name\":\"JAMA Network Open\",\"volume\":\"8 9\",\"pages\":\"e2529762\"},\"PeriodicalIF\":9.7000,\"publicationDate\":\"2025-09-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406060/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA Network Open\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamanetworkopen.2025.29762\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA Network Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamanetworkopen.2025.29762","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial.
Importance: Controlling modifiable cardiovascular risk factors is important but underused for patients with type 2 diabetes (T2D). Mobile message-based intervention strategies could address this gap but lack evidence of benefit on multiple risk factors.
Objective: To evaluate the effectiveness of a mobile message-based intervention in controlling cardiovascular risk factors in patients with T2D.
Design, setting, and participants: In this randomized clinical trial, adults with uncontrolled T2D comorbid with cardiovascular disease (CVD) risk factors were recruited from 5 clinical centers in China. Data were collected from November 2018 to March 2022 and analyzed from January to June 2023.
Intervention: Participants were randomized to receive either usual care or a mobile message-based intervention of 6 text messages per week from different modules designed to remind, encourage, and motivate them to participate in the behaviors needed for improving glycemic control and CVD risk factor management for 12 months.
Main outcomes and measures: The primary outcome included mean changes in hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP) levels across 12 months. The secondary outcomes included the percentage of participants with controlled HbA1c at 12 months. Data were analyzed using the intention-to-treat principle.
Results: A total of 819 participants (552 men [67.4%]; mean [SD] age, 50.1 [11.9] years; mean [SD] HbA1c level, 10.2% [2.1%]) were enrolled, of whom 410 were randomized to the intervention group and 409 to the control group. During the 12-month intervention, significant reductions in the mobile message-based intervention group were observed for HbA1c levels by -2.8% (95% CI, -2.9% to -2.6%), LDL-C by -11.1 mg/dL (95% CI, -14.7 to -7.4 mg/dL), and SBP by -2.5 mm Hg (95% CI, -3.9 to -1.2 mm Hg), and in the usual care group, by -2.5% (95% CI, -2.7% to -2.3%) for HbA1c, -11.9 mg/dL (95% CI, -15.8 to -8.0 mg/dL) for LDL-C, and -0.1 mm Hg (95% CI, -1.6 to 1.3 mm Hg) for SBP. The net group differences were -0.3% (95% CI, -0.5% to -0.0%) for HbA1c, 0.9 mg/dL (95% CI, -4.5 to 6.2 mg/dL) for LDL-C, and -2.4 mm Hg (95% CI, -4.3 to -0.4 mm Hg) for SBP (P = .001 for the combined overall effect). The percentage of participants with controlled HbA1c among all participants was significantly higher in the intervention group than in the control group at 12 months (195 participants [54.0%] vs 146 participants [46.1%]; P = .04).
Conclusions and relevance: In this randomized clinical trial of adults with uncontrolled T2D in China, a mobile message-based intervention resulted in a modest improvement in HbA1c and SBP in patients with diabetes compared with usual care. These results suggest that mobile message-based strategies for improving glycemic control and CVD risk factors should be considered for adults with T2D.
期刊介绍：
JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health.
JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
