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Clinical Trials/NCT04256460
NCT04256460
Completed
Not Applicable

Shanghai Community Prediabetes Standardized Management Project

Shanghai 6th People's Hospital53 sites in 1 country2,500 target enrollmentDecember 1, 2019
ConditionsPreDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Shanghai 6th People's Hospital
Enrollment
2500
Locations
53
Primary Endpoint
Change of BMI from baseline at 12 months
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
December 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Weiping Jia

Professor, Director of Shanghai Diabetes Institute

Shanghai 6th People's Hospital

Eligibility Criteria

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))

Outcomes

Primary Outcomes

Change of BMI from baseline at 12 months

Time Frame: Baseline, 12 months

body mass index, using the examination results of height (cm) and weight (kg)

Secondary Outcomes

  • Change of Triglyceride from baseline at 12 months(Baseline, 12 months)
  • Change of HbA1c from baseline at 12 months(Baseline, 12 months)
  • Change of Fasting Plasma Glucose from baseline at 12 months(Baseline, 12 months)
  • Change of Low density lipoprotein cholesterol from baseline at 12 months(Baseline, 12 months)
  • Change of Waist circumference from baseline at 12 months(Baseline, 12 months)
  • Change of High density lipoprotein cholesterol from baseline at 12 months(Baseline, 12 months)
  • Change of Blood Pressure from baseline at 12 months(Baseline, 12 months)
  • Change of Total Cholesterol from baseline at 12 months(Baseline, 12 months)

Study Sites (53)

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