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Shanghai Community Prediabetes Standardized Management Project

Primary Purpose

PreDiabetes

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Healthy diet, regular exercises and peer support
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring prediabetes, life style intervention, peer support, self management support, primary healthcare, community

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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))

Sites / Locations

  • Anting community health service center
  • Baihe community health service center
  • Beiwaitan community health service center
  • Caoyang community health service center
  • Changfeng baiyu community health service center
  • Changfeng changfeng community health service center
  • Changqiao community health service center
  • Changshou community health service center
  • Changzhengzhen community health service center
  • Chendun community health service center
  • Chonggu community health service center
  • Dahua community health service center
  • Dongjing community health service center
  • Fangsong community health service center
  • Fenglin community health service center
  • Ganquan community health service center
  • Hongmei community health service center
  • Huamu community health service center
  • Huangdu community health service center
  • Huinan community health service center
  • Jiangwan community health service center
  • Jinqiao community health service center
  • Jinyang community health service center
  • Juyuanxinqu community health service center
  • Kangjian community health service center
  • Liantang community health service center
  • Longhua community health service center
  • Luodian community health service center
  • Luojing community health service center
  • Malu community health service center
  • Miaohang community health service center
  • Nanjingxi Road community health service center
  • Nanxiang community health service center
  • Nicheng community health service center
  • Puxing community health service center
  • Qilian community health service center
  • Quyang community health service center
  • Sheshan community health service center
  • Shiquan community health service center
  • Songnan community health service center
  • Tangzhen community health service center
  • Taopuzhen community health service center
  • Taopuzhen No.2 community health service center
  • Tianlin community health service center
  • Waigang community health service center
  • Xianghuaqiao community health service center
  • Xiaokunshan community health service center
  • Yichuan community health service center
  • Yuepu community health service center
  • Zhaoxiang community health service center
  • Zhenruzhen community health service center
  • Zhongshan community health service center
  • Zhujiajiao community health service center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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

Receiving regular care and follow up in Community health centers

Outcomes

Primary Outcome Measures

Change of BMI from baseline at 12 months
body mass index, using the examination results of height (cm) and weight (kg)

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2019
Last Updated
May 4, 2022
Sponsor
Shanghai 6th People's Hospital
Collaborators
Shanghai Municipal Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04256460
Brief Title
Shanghai Community Prediabetes Standardized Management Project
Official Title
Shanghai Community Prediabetes Standardized Management Project
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
Collaborators
Shanghai Municipal Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
prediabetes, life style intervention, peer support, self management support, primary healthcare, community

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Receiving regular care and follow up in Community health centers
Intervention Type
Behavioral
Intervention Name(s)
Healthy diet, regular exercises and peer support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of BMI from baseline at 12 months
Description
body mass index, using the examination results of height (cm) and weight (kg)
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change of HbA1c from baseline at 12 months
Description
hemoglobin A1c (%)
Time Frame
Baseline, 12 months
Title
Change of Waist circumference from baseline at 12 months
Description
Waist circumference (cm)
Time Frame
Baseline, 12 months
Title
Change of Fasting Plasma Glucose from baseline at 12 months
Description
fasting plasma glucose (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Blood Pressure from baseline at 12 months
Description
Blood pressure including systolic blood pressure and diastolic blood pressure (mmHg)
Time Frame
Baseline, 12 months
Title
Change of Total Cholesterol from baseline at 12 months
Description
total cholesterol (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Triglyceride from baseline at 12 months
Description
Triglyceride (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of High density lipoprotein cholesterol from baseline at 12 months
Description
High density lipoprotein-Cholesterol (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Low density lipoprotein cholesterol from baseline at 12 months
Description
Low density lipoprotein-Cholesterol (mmol/L)
Time Frame
Baseline, 12 months
Other Pre-specified Outcome Measures:
Title
Change of Liver Functioning from baseline at 12 months
Description
alanine transaminase (U/L), Aspartate transaminase (U/L), Alkaline phosphatase (U/L), glutamyltransferase (U/L)
Time Frame
Baseline, 12 months
Title
Change of Urine Albumin/Creatinine Ratio from baseline at 12 months
Description
Albumin (mg/L), Creatinine (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Bilirubin from baseline at 12 months
Description
Total bilirubin (μmol/L), Direct bilirubin (μmol/L) Total bilirubin (μmol/L), Direct bilirubin (μmol/L)
Time Frame
Baseline, 12 months
Title
Change of Blood Urea from baseline at 12 months
Description
Blood urea (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Serum Creatinine from baseline at 12 months
Description
Serum creatinine (μmol/L)
Time Frame
Baseline, 12 months
Title
Change of Uric Acid from baseline at 12 months
Description
Uric acid (μmol/L)
Time Frame
Baseline, 12 months
Title
Change of oral glucose tolerance test-2 hour from baseline at 12 months
Description
oral glucose tolerance test-2 hour (mmol/L)
Time Frame
Baseline, 12 months
Title
Change of Diabetes Self Care Behaviors from baseline at 12 months
Description
9 items from Summary of Diabetes Self Care Activities and Behavioral Risk Factor Surveillance System. Items 1-7 measure diabetes self care activities during the previous 7 days. Items 1, 2, 4-7 are assessed on a scale of 0 to 7 days. Item 3 is assessed on scale of 1-4, where 1 represents very low levels of daily activity and 4 represents very high levels of daily activity. Items 8 and 9 are yes/no questions that measure cigarette intake over the past 7 and 30 days.
Time Frame
Baseline, 12 months
Title
Change of General Quality of Life from baseline at 12 months
Description
6-item Euro quality-of-life-5D, a standardized instrument for measuring generic health status. The respondents are asked to choose one of the statements which best describes their health status on the surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Item 6 is the visual analogue scale, in which respondents are asked to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100, where 0 corresponds to "the worst health you can imagine", and 100 corresponds to "the best health you can imagine"
Time Frame
Baseline, 12 months
Title
Change of Diabetes Quality of Life from baseline at 12 months
Description
4-item Diabetes Distress Scale, an abbreviated version of the 17-item Diabetes Distress Scale. The respondents are asked to respond to which degree each of the items has bothered them in the past month on a 6-point scale (1-6), where 1 is not a brother and 6 is very bothersome. Scores are summed and divided by 4 to calculate the mean. Mean scores of 3 or higher (moderate distress) are considered worthy of clinical attention.
Time Frame
Baseline, 12 months
Title
Change of Depression from baseline at 12 months
Description
8-item Patient Health Questionnaire (PHQ), the PHQ-9 minus the last question on suicidal thoughts. The PHQ is a standard instrument used in primary care settings to screen for the presence and severity of depression. The respondents are asked how often they have been bothered by each of the 8 items in the past 2 weeks on a 4 point scale (0-3), where 0 is "not all" and 3 is "nearly every day". The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.
Time Frame
Baseline, 12 months
Title
Change of Insulin Attitudes from baseline at 12 months
Description
6 questions
Time Frame
Baseline, 12 months
Title
Change of Neighborhood Interactions from baseline at 12 months
Description
6 questions
Time Frame
Baseline, 12 months
Title
Change of Peer Support Engagement and Health Care Utilization from baseline at 12 months
Description
5 questions
Time Frame
Baseline, 12 months
Title
Change of General information and risk factors questionnaire from baseline at 12 months
Description
Demographic questions, medical histories, risk factors including family history, smoking, alcohol drinking, diet, and exercises, medication information and adherence.
Time Frame
Baseline, 12 months
Title
Change of C-reaction protein from baseline at 12 months
Description
C-reaction protein
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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))
Facility Information:
Facility Name
Anting community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Baihe community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Beiwaitan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Caoyang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Changfeng baiyu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Changfeng changfeng community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Changqiao community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Changshou community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Changzhengzhen community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chendun community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chonggu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Dahua community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Dongjing community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fangsong community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fenglin community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Ganquan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Hongmei community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huamu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huangdu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huinan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Jiangwan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Jinqiao community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Jinyang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Juyuanxinqu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Kangjian community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Liantang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Longhua community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Luodian community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Luojing community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Malu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Miaohang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Nanjingxi Road community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Nanxiang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Nicheng community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Puxing community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Qilian community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Quyang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Sheshan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shiquan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Songnan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangzhen community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Taopuzhen community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Taopuzhen No.2 community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianlin community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Waigang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xianghuaqiao community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xiaokunshan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Yichuan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Yuepu community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhaoxiang community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhenruzhen community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan community health service center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhujiajiao community health service center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Shanghai Community Prediabetes Standardized Management Project

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