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Completed

NCT Number: NCT01053195

Qingdao Diabetes Prevention Project

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qingdao Municipal Center for Disease Control & Prevention

Qingdao, Shandong, 266033, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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.

Primary outcomes

  1. Incidence of type 2 diabetes

    Time frame: 7-8 years

Secondary outcomes

  1. Cost-effectiveness of the lifestyle intervention

    Time frame: 7-8 years

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Qingdao Centers for Disease Control and Prevention
  • The World Diabetes Foundation

Registry information

Official study title

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

Acronym: QDDPP

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2010
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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