PrediabetesVHMCNCT07338552
Effectiveness of a Virtual Health Management Community (VHMC) for Pre-diabetes in China
A study testing VHMC-based Group Interaction Management in people with Prediabetes, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- VHMC-based Group Interaction Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- Usual Care, VHMC-based Group Interaction Management
- Keywords
- Prediabetes, Health management
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
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.
VHMC-based Group Interaction ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Usual Care |
| Intervention Group | Experimental | Not described Receives: Behavioral: VHMC-based Group Interaction Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (10)
HbA1c
Measured: From enrollment to the end of intervention at 6 months
Waist circumference
Measured: From enrollment to the end of intervention at 6 months
Hip circumferences
Measured: From enrollment to the end of intervention at 6 months
BMI
Measured: From enrollment to the end of intervention at 6 months
Dietary compliance assessed by the Food Frequency Questionnaire (FFQ)
Measured: From enrollment to the end of intervention at 6 months
Physical activity compliance assessed by the International Physical Activity Questionnaire (IPAQ)
Measured: From enrollment to the end of intervention at 6 months
Self-efficacy assessed by the General Self-Efficacy Scale (GSES)
Measured: From enrollment to the end of intervention at 6 months
Social support assessed by the Social Support Rating Scale (SSRS)
Measured: From enrollment to the end of intervention at 6 months
Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
Measured: From enrollment to the end of intervention at 6 months
Sense of coherence assessed by the 13-item Sense of Coherence scale (SOC-13)
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338552
- Sponsor's protocol ID
- RG2023-262-02
- Other IDs
- 72204277
- Acronym
- VHMC
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to participant privacy and confidentiality concerns, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Community-Based Digital Intervention for Prediabetes Management in China
- ClinicalTrials.gov ID
- NCT07338552
- Acronym / sponsor ID
- VHMC / RG2023-262-02
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Health management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Usual Care |
| Intervention Group | Experimental | Behavioral: VHMC-based Group Interaction Management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareThe 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. | Other | Control group |
| VHMC-based Group Interaction ManagementThe 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. | Behavioural | Intervention Group |
Primary outcome
Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).
Time frame: From enrollment to the end of intervention at 6 months
10 secondary outcomes
HbA1c
Time frame: From enrollment to the end of intervention at 6 months
Waist circumference
Time frame: From enrollment to the end of intervention at 6 months
Hip circumferences
Time frame: From enrollment to the end of intervention at 6 months
BMI
Time frame: 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
Physical activity compliance assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: 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
Social support assessed by the Social Support Rating Scale (SSRS)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. Due to participant privacy and confidentiality concerns, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VHMC-based Group Interaction Management in people with Prediabetes, run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiling Hu (86 1892210 2965, flying3061983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal 2-hPG (OGTT; ≥11.1 mmol/L). (time frame: From enrollment to the end of intervention at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.