Shanghai Community Prediabetes Standardized Management Project

Study Overview
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Brief Summary
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Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes.

Detailed Description
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Participants with prediabetes is the key targets for diabetes prevention. So, in order to further strengthen and standardize the management of participants with prediabetes in the communities, the investigators start this project of standardized management of participants with prediabetes in communities of Shanghai. Explore the standardized management model for prediabetes participants within primary healthcare settings in Shanghai, to reduce the risk factors of diabetes, improve the blood glucose control, and the quality of life of participants with prediabetes. Through the collaboration the Shanghai Municipal Center for Disease Control & Prevention network, this investigators will implement prediabetes screening and lifestyle intervention in around 50 community health service centers in Shanghai. Life-style interventions including exercise and diet, and diabetes prevention knowledge will be integrated into train-the-trainers workshops. Trainings will be provided to community health service staff and peer supporters or social workers.

Official Title
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Shanghai Community Prediabetes Standardized Management Project

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Healthy diet, regular exercises and peer support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese residents Adult age ≥ 18 years old, 35-75 years old preferred Participants receiving prediabetes management of the basic public health services package in community health centers BMI≥24 kg/m2 or central obesity (Waist circumference≥90 cm in males，Waist circumference≥85 cm in females) or Hypertension (SBP≥140 mmHg and/or DBP≥90 mmHg) preferred Signed informed consents and willing to participate Exclusion Criteria: With serious chronic diseases, tumors, acute and chronic infectious diseases, limb movement disorders, and any mental illnesses Women during pregnancy or breastfeeding With excessive drinking or illicit drug use Unwilling to participate in the project Histories of severe cardiovascular events (myocardial infarction, stroke, acute coronary syndrome, or transient ischemic attack (TIA))

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Behavior intervention including health education on diet, exercises and self management support through peer support, and also receive regular care and follow up in community health centers | Behavioral: Healthy diet, regular exercises and peer support<br>* After assessing the exercise and nutritional status of the participants, health staff in community health centers implemented personalized healthy diet and regular exercises intervention, including coaching on healthy exercises and developing personalized dietary prescriptions for participants. Besides, peer support is implemented as a self management strategy in community health service centers or community self management groups to enhance the behavioral change support for these participants.<br>|
| No Intervention: Control arm<br>Receiving regular care and follow up in Community health centers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BMI from baseline at 12 months | body mass index, using the examination results of height (cm) and weight (kg) | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c from baseline at 12 months | hemoglobin A1c (%) | Baseline, 12 months | 
| Change of Waist circumference from baseline at 12 months | Waist circumference (cm) | Baseline, 12 months | 
| Change of Fasting Plasma Glucose from baseline at 12 months | fasting plasma glucose (mmol/L) | Baseline, 12 months | 
| Change of Blood Pressure from baseline at 12 months | Blood pressure including systolic blood pressure and diastolic blood pressure (mmHg) | Baseline, 12 months | 
| Change of Total Cholesterol from baseline at 12 months | total cholesterol (mmol/L) | Baseline, 12 months | 
| Change of Triglyceride from baseline at 12 months | Triglyceride (mmol/L) | Baseline, 12 months | 
| Change of High density lipoprotein cholesterol from baseline at 12 months | High density lipoprotein-Cholesterol (mmol/L) | Baseline, 12 months | 
| Change of Low density lipoprotein cholesterol from baseline at 12 months | Low density lipoprotein-Cholesterol (mmol/L) | Baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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community, prediabetes, life style intervention, peer support, self management support, primary healthcare