Effectiveness of a Virtual Health Management Community (VHMC) for Pre-diabetes in China (VHMC)

January 5, 2026 updated by: Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University

A Virtual Community-Based Digital Intervention for Prediabetes Management in China

Individuals with prediabetes are at high risk for developing type 2 diabetes mellitus (T2DM) and are therefore prone to serious complications such as stroke, kidney failure, blindness, and lower-limb amputation. Prediabetes can be reversed, and lifestyle modification is considered the most effective intervention for diabetes prevention. However, it is difficult for individuals with prediabetes to maintain long-term healthy lifestyle changes owing to psychological burnout and poor adherence during daily self-management. We developed a novel virtual health management community (VHMC) model based on group interaction management. The purpose of this study is to evaluate whether a virtual health management community-based intervention can improve glycemic control and related health outcomes in adults with prediabetes.

Participants in the intervention group will receive lifestyle management support through a virtual health management community, including health education, lifestyle guidance, and group-based interaction delivered via a digital platform.

Participants will be randomly assigned to either the virtual health management community intervention group or a usual care control group.

The study will follow participants for approximately 6 months.

Participants in the intervention group will receive lifestyle management support through a virtual health management community, including health education, lifestyle guidance, and group-based interaction delivered via a digital platform.

Participants will be randomly assigned to either the virtual health management community intervention group or a usual care control group.

The study will follow participants for approximately 6 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

Prediabetes, including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), is a metabolic state characterized by elevated blood glucose levels that do not yet meet the diagnostic criteria for diabetes. China has the highest prevalence of prediabetes among adults, estimated at 35.2%. Individuals with prediabetes are at high risk of progressing to type 2 diabetes mellitus (T2DM), which is associated with severe complications such as cardiovascular disease, kidney failure, blindness, and substantial economic burden. Therefore, preventing the progression from prediabetes to diabetes is an urgent public health priority.

Lifestyle modification is recognized as the most effective strategy for diabetes prevention; however, long-term adherence remains challenging. Traditional self-management interventions predominantly focus on individual-level behavior change, often overlooking the role of social support and community engagement. Group-based health management has the potential to provide social, practical, and emotional support, thereby enhancing self-efficacy, but existing models are frequently passive, fragmented, and difficult to sustain over time.

Virtual health communities (VHCs) provide online platforms that facilitate social interaction and self-management, overcoming geographical and time constraints while promoting active engagement. Although VHC-based group management approaches have been applied in various chronic diseases, their application in individuals with prediabetes remains limited. Moreover, many existing models lack sufficient group interaction and emotional engagement to support sustained behavior change.

To address these gaps, we developed a novel Virtual Health Management Community (VHMC) model that integrates structured group interaction management with digital health support, including dedicated patient and health manager modules. This study aims to apply the VHMC platform in individuals with prediabetes and to evaluate the effectiveness of this group interaction-based management model in improving glycemic control and related health outcomes.

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 (Estimated)

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.
146

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:

  • Participants who meet the 1999 World Health Organization (WHO) diagnostic criteria and the 2010 American Diabetes Association (ADA) definition for prediabetes, including: impaired fasting glucose (IFG): fasting plasma glucose (FPG) 6.1-<7.0 mmol/L and 2-hour plasma glucose (2-hPG) <7.8 mmol/L during a 75-g oral glucose tolerance test (OGTT); or impaired glucose tolerance (IGT): FPG <7.0 mmol/L and 2-hPG 7.8-<11.1 mmol/L during a 75-g OGTT; or HbA1c 5.7%-6.4%;
  • Age ≥18 years;
  • Clear consciousness and adequate comprehension ability;
  • Able to use a smartphone and have access to the Internet at home;
  • Willing to participate in the study and provide written informed consent;
  • Able to understand the purpose, procedure, and nature of the study.

Exclusion Criteria:

  • Participants with significant cognitive impairment or mental disorders;
  • Participants with severe malignant tumours;
  • Participants with severe acute or chronic complications, such as blindness, heart failure, or 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Intervention Group
Behavioral: VHMC-based Group Interaction Management
The intervention group will receive group interaction management based on the Virtual Health Management Community (VHMC) plan. After enrollment, health managers and patients will participate in face-to-face group consultations to clarify roles and responsibilities in self-management and group management, elicit patients' self-motivation statements, and jointly develop meaningful individual- and group-level goals. Health managers will then assist patients in downloading the VHMC platform application and guide them through its modules. After the face-to-face consultations, patients will log into the platform at home to access health information, record diabetes-related daily experiences, participate in community interactions, and implement lifestyle interventions. Health managers will continuously assess participants' progress in knowledge acquisition and lifestyle implementation and provide feedback and guidance throughout the intervention period.
Active Comparator: Control group
Other: Usual Care
The control group participants will receive conventional health education including disease-related knowledge, diet skills, exercise skills, comprehensive management goals (for blood glucose, weight, blood pressure, and blood lipids), and general education regarding lifestyle modification, delivered verbally or in the form of pamphlets.

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
Time Frame
Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

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
HbA1c
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Waist circumference
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Hip circumferences
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
BMI
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Dietary compliance assessed by the Food Frequency Questionnaire (FFQ)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Physical activity compliance assessed by the International Physical Activity Questionnaire (IPAQ)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Self-efficacy assessed by the General Self-Efficacy Scale (GSES)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Social support assessed by the Social Support Rating Scale (SSRS)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Sense of coherence assessed by the 13-item Sense of Coherence scale (SOC-13)
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

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 (Estimated)

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 30, 2025

Primary Completion (Estimated)

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.
December 30, 2026

Study Completion (Estimated)

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.
December 30, 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 19, 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 5, 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 14, 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.
January 14, 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.
January 5, 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.
November 1, 2025

More Information

Terms related to this study

Keywords

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.
  • RG2023-262-02
  • 72204277 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to participant privacy and confidentiality concerns, individual participant data will not be shared.

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.

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