Type 2 Diabetes Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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