About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Usual Care
Other interventionThe 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 Management
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).
Secondary outcomes
HbA1c
Waist circumference
Hip circumferences
BMI
Locations
Sponsors and contacts
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