Shanghai Community Prediabetes Standardized Management Project

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Healthy diet, regular exercises and peer support

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.

• Study Type: Interventional
• Enrollment (Actual): 2500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; 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; 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.
NO_INTERVENTION: Control arm; Receiving regular care and follow up in Community health centers

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Liver Functioning from baseline at 12 months	alanine transaminase (U/L), Aspartate transaminase (U/L), Alkaline phosphatase (U/L), glutamyltransferase (U/L)	Baseline, 12 months
Change of Urine Albumin/Creatinine Ratio from baseline at 12 months	Albumin (mg/L), Creatinine (mmol/L)	Baseline, 12 months
Change of Bilirubin from baseline at 12 months	Total bilirubin (μmol/L), Direct bilirubin (μmol/L) Total bilirubin (μmol/L), Direct bilirubin (μmol/L)	Baseline, 12 months
Change of Blood Urea from baseline at 12 months	Blood urea (mmol/L)	Baseline, 12 months
Change of Serum Creatinine from baseline at 12 months	Serum creatinine (μmol/L)	Baseline, 12 months
Change of Uric Acid from baseline at 12 months	Uric acid (μmol/L)	Baseline, 12 months
Change of oral glucose tolerance test-2 hour from baseline at 12 months	oral glucose tolerance test-2 hour (mmol/L)	Baseline, 12 months
Change of Diabetes Self Care Behaviors from baseline at 12 months	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.	Baseline, 12 months
Change of General Quality of Life from baseline at 12 months	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"	Baseline, 12 months
Change of Diabetes Quality of Life from baseline at 12 months	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.	Baseline, 12 months
Change of Depression from baseline at 12 months	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.	Baseline, 12 months
Change of Insulin Attitudes from baseline at 12 months	6 questions	Baseline, 12 months
Change of Neighborhood Interactions from baseline at 12 months	6 questions	Baseline, 12 months
Change of Peer Support Engagement and Health Care Utilization from baseline at 12 months	5 questions	Baseline, 12 months
Change of General information and risk factors questionnaire from baseline at 12 months	Demographic questions, medical histories, risk factors including family history, smoking, alcohol drinking, diet, and exercises, medication information and adherence.	Baseline, 12 months
Change of C-reaction protein from baseline at 12 months	C-reaction protein	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Collaborators: Shanghai Municipal Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: community; prediabetes; peer support; primary healthcare; life style intervention; self management support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Shanghai6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No