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
  Purpose

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.

Condition Intervention
Type 2 Diabetes
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Community-based Lifestyle Intervention to Reduce the Risk of Diabetes in Qingdao, China----Qingdao Diabetes Prevention Project (2005-2012)

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Incidence of type 2 diabetes [ Time Frame: 7-8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness of the lifestyle intervention [ Time Frame: 7-8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: December 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053195

Locations
China, Shandong
Qingdao Municipal Center for Disease Control & Prevention
Qingdao, Shandong, China, 266033
Sponsors and Collaborators
Helsinki University
The World Diabetes Foundation
Qingdao Municipal Center For Disease Control & Prevention
Investigators
Principal Investigator: Qing Qiao, MD, PhD Department of Public Health, University of Helsinki
  More Information

Publications:

Responsible Party: Qing Qiao, University of Helsinki
ClinicalTrials.gov Identifier: NCT01053195     History of Changes
Other Study ID Numbers: WDF07-308
Study First Received: January 19, 2010
Last Updated: January 20, 2010
Health Authority: Denmark: The World Diabetes Foundation

Keywords provided by Helsinki University:
Diabetes
prevention
intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014