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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,500

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

53 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

October 16, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed

2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

October 16, 2019

Last Update Submit

May 11, 2024

Conditions

PreDiabetes

Keywords

prediabeteslife style interventionpeer supportself management supportprimary healthcarecommunity

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

Change of HbA1c from baseline at 12 months
Baseline, 12 months
Change of Waist circumference from baseline at 12 months
Baseline, 12 months
Change of Fasting Plasma Glucose from baseline at 12 months
Baseline, 12 months
Change of Blood Pressure from baseline at 12 months
Baseline, 12 months
Change of Total Cholesterol from baseline at 12 months
Baseline, 12 months
+3 more secondary outcomes

Other Outcomes (16)

Change of Liver Functioning from baseline at 12 months
Baseline, 12 months
Change of Urine Albumin/Creatinine Ratio from baseline at 12 months
Baseline, 12 months
Change of Bilirubin from baseline at 12 months
Baseline, 12 months
+13 more other outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Receiving regular care and follow up in Community health centers

Interventions

Healthy diet, regular exercises and peer supportBEHAVIORAL

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 arm

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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))

Contact the study team to confirm eligibility.