Prediabetes
Conditions
Brief summary
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.
Interventions
OTHERPre-diabetes Virtual Community
By collecting general information, physical measurements, glucose and lipid metabolism indicators, dietary habits, and exercise routines from prediabetic patients, these details are input into the virtual community programme for prediabetes. The virtual community evaluates the input data, alerts healthcare professionals to patients requiring immediate intervention, and provides guidance for the forthcoming week regarding diet, exercise, and other health aspects (including dietary and exercise advice for prediabetic patients), alongside risk alerts.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 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 | 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 | From enrolment to the conclusion of the study, 2 weeks. | — |
| Two-hour postprandial blood glucose | From enrolment to the conclusion of the study, 2 weeks. | — |
| Task Completion Rate | 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%. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Outcome results
None listed