Clinical trial NCT04256460: Shanghai Community Prediabetes Standardized Management Project
Official title: Shanghai Community Prediabetes Standardized Management Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: prediabetes
life style intervention
peer support
self management support
primary healthcare
community
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Center for Disease Control and Prevention
First posted: 2020-02-05
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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))

Primary outcomes:
measure: Change of BMI from baseline at 12 months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change of HbA1c from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Waist circumference from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Fasting Plasma Glucose from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Blood Pressure from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Total Cholesterol from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Triglyceride from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of High density lipoprotein cholesterol from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Low density lipoprotein cholesterol from baseline at 12 months
timeFrame: Baseline, 12 months
Other outcomes:
measure: Change of Liver Functioning from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Urine Albumin/Creatinine Ratio from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Bilirubin from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Blood Urea from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Serum Creatinine from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Uric Acid from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of oral glucose tolerance test-2 hour from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Diabetes Self Care Behaviors from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of General Quality of Life from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Diabetes Quality of Life from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Depression from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Insulin Attitudes from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Neighborhood Interactions from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of Peer Support Engagement and Health Care Utilization from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of General information and risk factors questionnaire from baseline at 12 months
timeFrame: Baseline, 12 months
measure: Change of C-reaction protein from baseline at 12 months
timeFrame: Baseline, 12 months
Locations:
city: Shanghai
country: China
facility: Anting community health service center
state: Shanghai
city: Shanghai
country: China
facility: Baihe community health service center
state: Shanghai
city: Shanghai
country: China
facility: Beiwaitan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Caoyang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Changfeng baiyu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Changfeng changfeng community health service center
state: Shanghai
city: Shanghai
country: China
facility: Changqiao community health service center
state: Shanghai
city: Shanghai
country: China
facility: Changshou community health service center
state: Shanghai
city: Shanghai
country: China
facility: Changzhengzhen community health service center
state: Shanghai
city: Shanghai
country: China
facility: Chendun community health service center
state: Shanghai
city: Shanghai
country: China
facility: Chonggu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Dahua community health service center
state: Shanghai
city: Shanghai
country: China
facility: Dongjing community health service center
state: Shanghai
city: Shanghai
country: China
facility: Fangsong community health service center
state: Shanghai
city: Shanghai
country: China
facility: Fenglin community health service center
state: Shanghai
city: Shanghai
country: China
facility: Ganquan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Hongmei community health service center
state: Shanghai
city: Shanghai
country: China
facility: Huamu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Huangdu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Huinan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Jiangwan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Jinqiao community health service center
state: Shanghai
city: Shanghai
country: China
facility: Jinyang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Juyuanxinqu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Kangjian community health service center
state: Shanghai
city: Shanghai
country: China
facility: Liantang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Longhua community health service center
state: Shanghai
city: Shanghai
country: China
facility: Luodian community health service center
state: Shanghai
city: Shanghai
country: China
facility: Luojing community health service center
state: Shanghai
city: Shanghai
country: China
facility: Malu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Miaohang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Nanjingxi Road community health service center
state: Shanghai
city: Shanghai
country: China
facility: Nanxiang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Nicheng community health service center
state: Shanghai
city: Shanghai
country: China
facility: Puxing community health service center
state: Shanghai
city: Shanghai
country: China
facility: Qilian community health service center
state: Shanghai
city: Shanghai
country: China
facility: Quyang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Sheshan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Shiquan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Songnan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Tangzhen community health service center
state: Shanghai
city: Shanghai
country: China
facility: Taopuzhen community health service center
state: Shanghai
city: Shanghai
country: China
facility: Taopuzhen No.2 community health service center
state: Shanghai
city: Shanghai
country: China
facility: Tianlin community health service center
state: Shanghai
city: Shanghai
country: China
facility: Waigang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Xianghuaqiao community health service center
state: Shanghai
city: Shanghai
country: China
facility: Xiaokunshan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Yichuan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Yuepu community health service center
state: Shanghai
city: Shanghai
country: China
facility: Zhaoxiang community health service center
state: Shanghai
city: Shanghai
country: China
facility: Zhenruzhen community health service center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan community health service center
state: Shanghai
city: Shanghai
country: China
facility: Zhujiajiao community health service center
state: Shanghai
Study officials:
References: