Qingdao Diabetes Prevention Project (QDDPP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The World Diabetes Foundation
Qingdao Municipal Center For Disease Control & Prevention
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT01053195
First received: January 19, 2010
Last updated: January 20, 2010
Last verified: January 2010

January 19, 2010
January 20, 2010
December 2005
July 2012   (final data collection date for primary outcome measure)
Incidence of type 2 diabetes [ Time Frame: 7-8 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053195 on ClinicalTrials.gov Archive Site
Cost-effectiveness of the lifestyle intervention [ Time Frame: 7-8 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Qingdao Diabetes Prevention Project
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Type 2 Diabetes
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.
  • 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.
    Intervention: Behavioral: Lifestyle counseling
  • No Intervention: Control
    No intervention activity will be assigned for participants enrolled from the control areas.
    Intervention: Behavioral: Lifestyle counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20000
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01053195
WDF07-308
Yes
Qing Qiao, University of Helsinki
Helsinki University
  • The World Diabetes Foundation
  • Qingdao Municipal Center For Disease Control & Prevention
Principal Investigator: Qing Qiao, MD, PhD Department of Public Health, University of Helsinki
Helsinki University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP