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The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.
Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol), and the proportion of participants with HbA1C <7% (<7.5% if with clinical CVD), BP<140/90 mm Hg, and LDL-cholesterol <100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention-Text messaging | Experimental | Participates will receive regular 6 text messages per week for 12 months. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. |
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| Control | No Intervention | Participates in control group will not receive text messages. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text messaging | Behavioral | Intervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Control: The control group will receive the usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose level measured by HbA1C level | 12 months | |
| Change in Systolic blood pressure level | 12 months | |
| Change in LDL-cholesterol level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huijie Zhang, M.D.&Ph.D | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40892411 | Derived | Zhang PZ, Guo D, Liu CQ, Chen N, Liu JF, Lei XZ, Yang LJ, Liu YT, Li X, Huang JF, Du CM, Wang K, Mo W, Lin JY, Huang CS, Xu BY, Wei XY, Liu DY, Huang JL, Huang Y, Xue YM, Zeng YM, Liu SQ, Ma ZM, Zhang HJ. Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529762. doi: 10.1001/jamanetworkopen.2025.29762. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care.
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The study is a two-arm, parallel, randomized clinical trial. The primary outcome and secondary outcomes was measured by blinded assessors throughout the study period.
|
| 12 months |
| The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease) | 12 months |
| The proportion achieving levels of blood pressure <140/90 mm Hg | 12 months |
| The proportion achieving levels of LDL-cholesterol <100 mg/dL | 12 months |
| Change in Framingham Risk Score | 12 months |
| Change in ACC/AHA Risk Score of CVD | 12 months |