Qingdao Diabetes Prevention Project (QDDPP)

August 25, 2016 updated by: Qing Qiao, University of Helsinki

A Community-based Lifestyle Intervention to Reduce the Risk of Diabetes in Qingdao, China----Qingdao Diabetes Prevention Project (2005-2012)

Qingdao Diabetes Prevention Project aims to translate the trial experience to communities with specific objectives to:

  • raise the public awareness of diabetes and diabetes risk factors
  • promote healthy lifestyle of the entire targeting population
  • reduce the number of people with obesity
  • reduce the number of high-risk people developing diabetes through lifestyle intervention
  • prevent the diabetic complications
  • evaluate the effect and the cost of the community-based prevention project. The project is community-based targeting at the entire population of 1.94 million living in four administration districts of the city of Qingdao in China. In the first phase of the project (2005-2008) the work emphasis is on health promotion, training over 2000 primary care professionals and 300 school health nurses and establishing a network consisting of 600 community clinics. In the second phase (2008-2012) lifestyle counseling sessions will be provided to about 242112 high-risk individuals identified, and the efficacy and the cost of the project will be evaluated at the end of the project in 2012.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Qingdao Diabetes Prevention Project targets at two urban districts of Shinan and Shibei and two rural counties of Huangdao and Jiaonan, covering 1.94 million of people living in 512 urban communities and 1128 rural natural villages. There are 637000 households in the targeting districts.

In the first 3-years (2005-2008) we have focused on preparing educational materials, health promotion, distributing the project materials, training health professionals, establishing the project networks, identifying high-risk individuals etc., while from 2008-2011 we will transfer our working emphasis on lifestyle intervention to those with high-risk for diabetes.

According to the data collected in 2006, about 456288 individuals aged 35 years or older are estimated to have a risk score >=14. We estimate that at least 65% of the non-diabetic high-risk individuals (n=242112) will be identified and referred to one of the 600 community clinics for lifestyle counseling and intervention.

Lifestyle intervention includes individual and group counseling sessions organised by the community doctors in a real life setting. The intervals of the counseling sessions depend on the glucose levels of the high-risk individuals, every three months for those having impaired fasting glucose or/and impaired glucose tolerance and every six months for those with normal glucose levels but with high risk score. At the end of the project, the cost-effectiveness of the community-based intervention will be evaluated.

Study Type

Interventional

Enrollment (Actual)

276793

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266033
        • Qingdao Municipal Center for Disease Control & Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals Aged 35 years or older
  • individuals at high risk for diabetes identified by a risk score assessment
  • individuals with baseline measurement of glucose

Exclusion Criteria:

  • individuals with a prior history of diabetes or taking antidiabetic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
In the project areas, lifestyle counseling will be given every three months to individuals having prediabetes and every six months to those with normal glucose levels.
Behavioral: Lifestyle counseling
Non-diabetic high-risk subjects enrolled will be eligible for individual and/or group lifestyle counseling. The intervals of the counseling sessions depend on the glucose levels of the high-risk individuals, every three months for those having prediabetes and every six months for those with normal glucose levels but high risk score.
No Intervention: Control
No intervention activity will be assigned for participants enrolled from the control areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of type 2 diabetes
Time Frame: 7-8 years
7-8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness of the lifestyle intervention
Time Frame: 7-8 years
7-8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

The World Diabetes Foundation
Qingdao Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Qing Qiao, MD, PhD, Department of Public Health, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDF07-308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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