- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354997
Establishing a Virtual Health Community Management Model for Pre-Diabetes Patients
Research on the Construction and Driving Mechanisms of an Interactive Management Model for Pre-diabetic Patient Groups Based on Virtual Health Communities
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-Sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets the diagnostic criteria for prediabetes: ①impaired fasting glucose (IFG): 6.1 mmol/L ≤ fasting plasma glucose (FPG) < 7.0 mmol/L and 2 h plasma glucose (2-hPG) after a 75 g oral glucose tolerance test (OGTT) < 7.80 mmol/L and impaired glucose tolerance (IGT): FPG<7.0 mmol/L and 7.8 mmol/L ≤ 2 hPG OGTT < 11.1 mmol/L], or HbA1c: 5.7-6.4%;
- Age ≥18 years;
- Clear awareness and comprehension ability;
- Able to use a smartphone and have access to internet at home;
- Willing to participate and sign the informed consent;
- Understand the purpose, procedure and nature of the study.
Exclusion Criteria:
- Severe cognitive impairment or mental disorder;
- Complicated with severe malignant tumours;
- Complicated with severe acute or chronic complications such as blindness, heart failure and end-stage renal disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre-diabetes Virtual Community Experience Group
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By collecting general information, physical measurements, glucose and lipid metabolism indicators, dietary habits, and exercise routines from prediabetic patients, these details are input into the virtual community programme for prediabetes.
The virtual community evaluates the input data, alerts healthcare professionals to patients requiring immediate intervention, and provides guidance for the forthcoming week regarding diet, exercise, and other health aspects (including dietary and exercise advice for prediabetic patients), alongside risk alerts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
Participants self-reported their daily physical activity levels, with the International Physical Activity Questionnaire (IPAQ) used to assess the frequency, duration, and intensity (i.e., light, moderate, and vigorous activities) of physical activity across different domains (work, transportation, household, and leisure) over the past 7 days.
|
From enrolment to the conclusion of the study, 2 weeks.
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|
Diet
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
Participants self-reported their daily meal consumption through periodic 24-hour dietary recalls or food diaries.
These data were then used to calculate the Planetary Health Diet Score, providing a weekly assessment of diet quality.
|
From enrolment to the conclusion of the study, 2 weeks.
|
|
Fasting blood glucose
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
From enrolment to the conclusion of the study, 2 weeks.
|
|
|
Two-hour postprandial blood glucose
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
From enrolment to the conclusion of the study, 2 weeks.
|
|
|
Task Completion Rate
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
Task Completion Rate is defined as the percentage of target users who successfully met the task criteria within the specified time frame and user scope. It directly reflects the implementation efficiency of the intervention and user adherence (e.g., dietary logging rate, exercise plan execution rate). Formula: Task Completion Rate = (Number of users who successfully completed the task / Total number of target users) × 100%. |
From enrolment to the conclusion of the study, 2 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Mass Index (BMI)
Time Frame: From enrolment to the conclusion of the study, 2 weeks.
|
From enrolment to the conclusion of the study, 2 weeks.
|
|
Total cholesterol
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
|
Triglycerides
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
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On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
|
High-density lipoprotein cholesterol (HDL-C)
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
|
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
On the first day of enrolment, at the conclusion of the intervention two weeks later.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG2023-262-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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