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临床试验/NCT07354997
NCT07354997已完成不适用

Research on the Construction and Driving Mechanisms of an Interactive Management Model for Pre-diabetic Patient Groups Based on Virtual Health Communities

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Physical activity

研究概览

简要总结

This study builds upon the previously developed virtual health community platform, aiming to address the group characteristics and psychological traits of prediabetic patients. By employing intervention mapping to construct a group interaction management model, it seeks to develop a mobile platform integrating "gamified knowledge acquisition and motivation", "immersive lifestyle practice experiences", and "sustained community interaction management". The primary focus is on fostering patients' continuous and proactive engagement. Subsequently, a single-arm controlled trial will validate the model's efficacy, aiming to address the health management challenges faced by China's substantial prediabetic population. This initiative seeks to provide theoretical foundations and practical support for primary prevention strategies targeting other chronic diseases and at-risk cohorts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets the diagnostic criteria for prediabetes: ①impaired fasting glucose (IFG): 6.1 mmol/L ≤ fasting plasma glucose (FPG) < 7.0 mmol/L and 2 h plasma glucose (2-hPG) after a 75 g oral glucose tolerance test (OGTT) < 7.80 mmol/L and impaired glucose tolerance (IGT): FPG<7.0 mmol/L and 7.8 mmol/L ≤ 2 hPG OGTT < 11.1 mmol/L], or HbA1c: 5.7-6.4%;
  • Age ≥18 years;
  • Clear awareness and comprehension ability;
  • Able to use a smartphone and have access to internet at home;
  • Willing to participate and sign the informed consent;
  • Understand the purpose, procedure and nature of the study.

排除标准

  • Severe cognitive impairment or mental disorder;
  • Complicated with severe malignant tumours;
  • Complicated with severe acute or chronic complications such as blindness, heart failure and end-stage renal disease.

研究组 & 干预措施

Pre-diabetes Virtual Community Experience Group

Experimental

干预措施: Pre-diabetes Virtual Community (Other)

结局指标

主要结局

Physical activity

时间窗: From enrolment to the conclusion of the study, 2 weeks.

Participants self-reported their daily physical activity levels, with the International Physical Activity Questionnaire (IPAQ) used to assess the frequency, duration, and intensity (i.e., light, moderate, and vigorous activities) of physical activity across different domains (work, transportation, household, and leisure) over the past 7 days.

Diet

时间窗: From enrolment to the conclusion of the study, 2 weeks.

Participants self-reported their daily meal consumption through periodic 24-hour dietary recalls or food diaries. These data were then used to calculate the Planetary Health Diet Score, providing a weekly assessment of diet quality.

Fasting blood glucose

时间窗: From enrolment to the conclusion of the study, 2 weeks.

Two-hour postprandial blood glucose

时间窗: From enrolment to the conclusion of the study, 2 weeks.

Task Completion Rate

时间窗: From enrolment to the conclusion of the study, 2 weeks.

Task Completion Rate is defined as the percentage of target users who successfully met the task criteria within the specified time frame and user scope. It directly reflects the implementation efficiency of the intervention and user adherence (e.g., dietary logging rate, exercise plan execution rate). Formula: Task Completion Rate = (Number of users who successfully completed the task / Total number of target users) × 100%.

次要结局

  • Body Mass Index (BMI)(From enrolment to the conclusion of the study, 2 weeks.)
  • Total cholesterol(On the first day of enrolment, at the conclusion of the intervention two weeks later.)
  • Triglycerides(On the first day of enrolment, at the conclusion of the intervention two weeks later.)
  • High-density lipoprotein cholesterol (HDL-C)(On the first day of enrolment, at the conclusion of the intervention two weeks later.)
  • Low-density lipoprotein cholesterol (LDL-C)(On the first day of enrolment, at the conclusion of the intervention two weeks later.)

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiling Hu

Chief Nurse

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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