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

ConditionPrediabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThird Affiliated Hospital, Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Usual Care

    Other intervention

    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 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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Abnormal 2-hPG (OGTT; ≥11.1 mmol/L).

Time frame
From enrollment to the end of intervention at 6 months

Secondary outcomes

1

HbA1c

Time frame
From enrollment to the end of intervention at 6 months
2

Waist circumference

Time frame
From enrollment to the end of intervention at 6 months
3

Hip circumferences

Time frame
From enrollment to the end of intervention at 6 months
4

BMI

Time frame
From enrollment to the end of intervention at 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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