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

February 9, 2026 updated by: Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The third affiliated hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre-diabetes Virtual Community Experience Group
Other: Pre-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrolment to the conclusion of the study, 2 weeks.
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.
From enrolment to the conclusion of the study, 2 weeks.
Fasting blood glucose
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
From enrolment to the conclusion of the study, 2 weeks.
Two-hour postprandial blood glucose
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
From enrolment to the conclusion of the study, 2 weeks.
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%.
From enrolment to the conclusion of the study, 2 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
From enrolment to the conclusion of the study, 2 weeks.
Total cholesterol
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
On the first day of enrolment, at the conclusion of the intervention two weeks later.
Triglycerides
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
On the first day of enrolment, at the conclusion of the intervention two weeks later.
High-density lipoprotein cholesterol (HDL-C)
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
On the first day of enrolment, at the conclusion of the intervention two weeks later.
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
On the first day of enrolment, at the conclusion of the intervention two weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG2023-262-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings