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

NCT07338552 | Not Yet Recruiting

• 2 other identifiers: RG2023-262-0272204277
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Prediabetes

Keywords

Prediabetes; Health management

Outcome Measures

Primary Outcomes (1)

• Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).

  From enrollment to the end of intervention at 6 months

Secondary Outcomes (10)

• HbA1c

  From enrollment to the end of intervention at 6 months

• Waist circumference

  From enrollment to the end of intervention at 6 months

• Hip circumferences

  From enrollment to the end of intervention at 6 months

• BMI

  From enrollment to the end of intervention at 6 months

• Dietary compliance assessed by the Food Frequency Questionnaire (FFQ)

  From enrollment to the end of intervention at 6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: Usual Care

Intervention Group

EXPERIMENTAL

Behavioral: VHMC-based Group Interaction Management

Interventions

Usual Care OTHER

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.

Control group

VHMC-based Group Interaction Management BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Xiling Hu

CONTACT

86 1892210 2965; flying3061983@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share