Shanghai Community Prediabetes Standardized Management Project

Shanghai Jiao Tong University

Status: Completed

Conditions: PreDiabetes

Treatments: Behavioral: Healthy diet, regular exercises and peer support

Study type: Interventional

Funder types: Other

Identifiers

NCT04256460

Shanghai6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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))

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,500 participants in 2 patient groups

Intervention arm

Experimental group

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

Treatment:

Behavioral: Healthy diet, regular exercises and peer support

Control arm

No Intervention group

Description:

Receiving regular care and follow up in Community health centers