Skip to main content
OpenTrials
Completed

NCT Number: NCT07354997

Establishing a Virtual Health Community Management Model for Pre-Diabetes Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-diabetes Virtual Community

Other

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.

Primary outcomes

  1. Physical activity

    Time frame: 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.

  2. Diet

    Time frame: 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.

  3. Fasting blood glucose

    Time frame: From enrolment to the conclusion of the study, 2 weeks.

  4. Two-hour postprandial blood glucose

    Time frame: From enrolment to the conclusion of the study, 2 weeks.

  5. Task Completion Rate

    Time frame: 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 outcomes

  1. Body Mass Index (BMI)

    Time frame: From enrolment to the conclusion of the study, 2 weeks.

  2. Total cholesterol

    Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.

  3. Triglycerides

    Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.

  4. High-density lipoprotein cholesterol (HDL-C)

    Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.

  5. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.