Shanghai Community Prediabetes Standardized Management Project

PreDiabetes Clinical Trial

Official title:

Shanghai Community Prediabetes Standardized Management Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256460
• Other study ID #: Shanghai6
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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))

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
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	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital	Shanghai Municipal Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change of Urine Albumin/Creatinine Ratio from baseline at 12 months	Albumin (mg/L), Creatinine (mmol/L)	Baseline, 12 months
Other	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
Other	Change of Blood Urea from baseline at 12 months	Blood urea (mmol/L)	Baseline, 12 months
Other	Change of Serum Creatinine from baseline at 12 months	Serum creatinine (µmol/L)	Baseline, 12 months
Other	Change of Uric Acid from baseline at 12 months	Uric acid (µmol/L)	Baseline, 12 months
Other	Change of oral glucose tolerance test-2 hour from baseline at 12 months	oral glucose tolerance test-2 hour (mmol/L)	Baseline, 12 months
Other	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
Other	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
Other	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
Other	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
Other	Change of Insulin Attitudes from baseline at 12 months	6 questions	Baseline, 12 months
Other	Change of Neighborhood Interactions from baseline at 12 months	6 questions	Baseline, 12 months
Other	Change of Peer Support Engagement and Health Care Utilization from baseline at 12 months	5 questions	Baseline, 12 months
Other	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
Other	Change of C-reaction protein from baseline at 12 months	C-reaction protein	Baseline, 12 months
Primary	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	Change of HbA1c from baseline at 12 months	hemoglobin A1c (%)	Baseline, 12 months
Secondary	Change of Waist circumference from baseline at 12 months	Waist circumference (cm)	Baseline, 12 months
Secondary	Change of Fasting Plasma Glucose from baseline at 12 months	fasting plasma glucose (mmol/L)	Baseline, 12 months
Secondary	Change of Blood Pressure from baseline at 12 months	Blood pressure including systolic blood pressure and diastolic blood pressure (mmHg)	Baseline, 12 months
Secondary	Change of Total Cholesterol from baseline at 12 months	total cholesterol (mmol/L)	Baseline, 12 months
Secondary	Change of Triglyceride from baseline at 12 months	Triglyceride (mmol/L)	Baseline, 12 months
Secondary	Change of High density lipoprotein cholesterol from baseline at 12 months	High density lipoprotein-Cholesterol (mmol/L)	Baseline, 12 months
Secondary	Change of Low density lipoprotein cholesterol from baseline at 12 months	Low density lipoprotein-Cholesterol (mmol/L)	Baseline, 12 months