Shanghai Community Prediabetes Standardized Management Project

NCT ID: NCT04256460

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Healthy diet, regular exercises and peer support

Intervention Type BEHAVIORAL

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.

Control arm

Receiving regular care and follow up in Community health centers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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))
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Municipal Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weiping Jia

Professor, Director of Shanghai Diabetes Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anting community health service center

Shanghai, Shanghai Municipality, China

Site Status

Baihe community health service center

Shanghai, Shanghai Municipality, China

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Beiwaitan community health service center

Shanghai, Shanghai Municipality, China

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Caoyang community health service center

Shanghai, Shanghai Municipality, China

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Changfeng baiyu community health service center

Shanghai, Shanghai Municipality, China

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Changfeng changfeng community health service center

Shanghai, Shanghai Municipality, China

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Changqiao community health service center

Shanghai, Shanghai Municipality, China

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Changshou community health service center

Shanghai, Shanghai Municipality, China

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Changzhengzhen community health service center

Shanghai, Shanghai Municipality, China

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Chendun community health service center

Shanghai, Shanghai Municipality, China

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Chonggu community health service center

Shanghai, Shanghai Municipality, China

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Dahua community health service center

Shanghai, Shanghai Municipality, China

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Dongjing community health service center

Shanghai, Shanghai Municipality, China

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Fangsong community health service center

Shanghai, Shanghai Municipality, China

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Fenglin community health service center

Shanghai, Shanghai Municipality, China

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Ganquan community health service center

Shanghai, Shanghai Municipality, China

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Hongmei community health service center

Shanghai, Shanghai Municipality, China

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Huamu community health service center

Shanghai, Shanghai Municipality, China

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Huangdu community health service center

Shanghai, Shanghai Municipality, China

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Huinan community health service center

Shanghai, Shanghai Municipality, China

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Jiangwan community health service center

Shanghai, Shanghai Municipality, China

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Jinqiao community health service center

Shanghai, Shanghai Municipality, China

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Jinyang community health service center

Shanghai, Shanghai Municipality, China

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Juyuanxinqu community health service center

Shanghai, Shanghai Municipality, China

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Kangjian community health service center

Shanghai, Shanghai Municipality, China

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Liantang community health service center

Shanghai, Shanghai Municipality, China

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Longhua community health service center

Shanghai, Shanghai Municipality, China

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Luodian community health service center

Shanghai, Shanghai Municipality, China

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Luojing community health service center

Shanghai, Shanghai Municipality, China

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Malu community health service center

Shanghai, Shanghai Municipality, China

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Miaohang community health service center

Shanghai, Shanghai Municipality, China

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Nanjingxi Road community health service center

Shanghai, Shanghai Municipality, China

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Nanxiang community health service center

Shanghai, Shanghai Municipality, China

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Nicheng community health service center

Shanghai, Shanghai Municipality, China

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Puxing community health service center

Shanghai, Shanghai Municipality, China

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Qilian community health service center

Shanghai, Shanghai Municipality, China

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Quyang community health service center

Shanghai, Shanghai Municipality, China

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Sheshan community health service center

Shanghai, Shanghai Municipality, China

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Shiquan community health service center

Shanghai, Shanghai Municipality, China

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Songnan community health service center

Shanghai, Shanghai Municipality, China

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Tangzhen community health service center

Shanghai, Shanghai Municipality, China

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Taopuzhen community health service center

Shanghai, Shanghai Municipality, China

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Taopuzhen No.2 community health service center

Shanghai, Shanghai Municipality, China

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Tianlin community health service center

Shanghai, Shanghai Municipality, China

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Waigang community health service center

Shanghai, Shanghai Municipality, China

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Xianghuaqiao community health service center

Shanghai, Shanghai Municipality, China

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Xiaokunshan community health service center

Shanghai, Shanghai Municipality, China

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Yichuan community health service center

Shanghai, Shanghai Municipality, China

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Yuepu community health service center

Shanghai, Shanghai Municipality, China

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Zhaoxiang community health service center

Shanghai, Shanghai Municipality, China

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Zhenruzhen community health service center

Shanghai, Shanghai Municipality, China

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Zhongshan community health service center

Shanghai, Shanghai Municipality, China

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Zhujiajiao community health service center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Shanghai6

Identifier Type: -

Identifier Source: org_study_id

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