Qingdao Diabetes Prevention Project (QDDPP)
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2010 | ||||
| Last Updated Date | January 20, 2010 | ||||
| Start Date ICMJE | December 2005 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of type 2 diabetes [ Time Frame: 7-8 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01053195 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cost-effectiveness of the lifestyle intervention [ Time Frame: 7-8 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Qingdao Diabetes Prevention Project | ||||
| Official Title ICMJE | A Community-based Lifestyle Intervention to Reduce the Risk of Diabetes in Qingdao, China----Qingdao Diabetes Prevention Project (2005-2012) | ||||
| Brief Summary | Qingdao Diabetes Prevention Project aims to translate the trial experience to communities with specific objectives to:
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE | 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. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 20000 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01053195 | ||||
| Other Study ID Numbers ICMJE | WDF07-308 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Qing Qiao, University of Helsinki | ||||
| Study Sponsor ICMJE | Helsinki University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Helsinki University | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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