Type 2 DiabetesQDDPPNCT01053195
Qingdao Diabetes Prevention Project
A study testing Lifestyle counseling in people with Type 2 Diabetes, run by University of Helsinki at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276,793 participants
- Where
- 1 siteChina
- Study dates
- Dec 2005to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals Aged 35 years or older
- individuals at high risk for diabetes identified by a risk score assessment
- individuals with baseline measurement of glucose
Who cannot join
- individuals with a prior history of diabetes or taking antidiabetic drugs
Trial locations and contacts
1 site in 1 country.
China1 site
Qingdao Municipal Center for Disease Control & Prevention
Qingdao, Shandong, 266033
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Lifestyle counseling
- Keywords
- Diabetes, prevention, intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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. Receives: Behavioral: Lifestyle counseling |
| Control | No intervention | No intervention activity will be assigned for participants enrolled from the control areas. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes
Measured: 7-8 years
Secondary outcomes (1)
Cost-effectiveness of the lifestyle intervention
Measured: 7-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startDec 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- The World Diabetes Foundation, Qingdao Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Qing Qiao, University of Helsinki
- Investigators
- Qing Qiao, MD, PhD, Principal investigator, Department of Public Health, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053195
- Sponsor's protocol ID
- WDF07-308
- Acronym
- QDDPP
- Status last verified
- Aug 2016
- First submitted
- 19 Jan 2010
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dong Y, Gao W, Nan H, Yu H, Li F, Duan W, Wang Y, Sun B, Qian R, Tuomilehto J, Qiao Q. Prevalence of Type 2 diabetes in urban and rural Chinese populations in Qingdao, China. Diabet Med. 2005 Oct;22(10):1427-33. doi: 10.1111/j.1464-5491.2005.01658.x.
PubMed 16176207Pan XR, Hu YH, Li GW, Liu PA, Bennett PH, Howard BV. Impaired glucose tolerance and its relationship to ECG-indicated coronary heart disease and risk factors among Chinese. Da Qing IGT and diabetes study. Diabetes Care. 1993 Jan;16(1):150-6. doi: 10.2337/diacare.16.1.150.
PubMed 8422770Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
PubMed 9096977Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.
PubMed 16391903Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Jacobs-van der Bruggen MA, Bos G, Bemelmans WJ, Hoogenveen RT, Vijgen SM, Baan CA. Lifestyle interventions are cost-effective in people with different levels of diabetes risk: results from a modeling study. Diabetes Care. 2007 Jan;30(1):128-34. doi: 10.2337/dc06-0690.
PubMed 17192345Ning F, Pang ZC, Dong YH, Gao WG, Nan HR, Wang SJ, Zhang L, Ren J, Tuomilehto J, Hammar N, Malmberg K, Andersson SW, Qiao Q; Qingdao Diabetes Survey Group. Risk factors associated with the dramatic increase in the prevalence of diabetes in the adult Chinese population in Qingdao, China. Diabet Med. 2009 Sep;26(9):855-63. doi: 10.1111/j.1464-5491.2009.02791.x.
PubMed 19719705Ning F, Zhao J, Zhang L, Wang W, Sun X, Song X, Zhang Y, Xin H, Gao W, Gao R, Zhang D, Pang Z. Famine exposure in early life and type 2 diabetes in adulthood: findings from prospective studies in China. Nutr Res Pract. 2023 Aug;17(4):780-788. doi: 10.4162/nrp.2023.17.4.780. Epub 2023 Mar 13.
PubMed 37529266
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Lifestyle Intervention to Reduce the Risk of Diabetes in Qingdao, China----Qingdao Diabetes Prevention Project (2005-2012)
- ClinicalTrials.gov ID
- NCT01053195
- Acronym / sponsor ID
- QDDPP / WDF07-308
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, prevention, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276,793 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- The World Diabetes Foundation, Qingdao Centers for Disease Control and Prevention
- Study start
- Dec 2005
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingIn 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. |
| Control | No intervention | –No intervention activity will be assigned for participants enrolled from the control areas. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals Aged 35 years or older
- individuals at high risk for diabetes identified by a risk score assessment
- individuals with baseline measurement of glucose
Key exclusion criteria (1 listed)
- individuals with a prior history of diabetes or taking antidiabetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselingNon-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. | Behavioural | Lifestyle counseling |
Primary outcome
Incidence of type 2 diabetes
Time frame: 7-8 years
1 secondary outcome
Cost-effectiveness of the lifestyle intervention
Time frame: 7-8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Background: PubMed 16176207Dong Y, Gao W, Nan H, Yu H, Li F, Duan W, Wang Y, Sun B, Qian R, Tuomilehto J, Qiao Q. Prevalence of Type 2 diabetes in urban and rural Chinese populations in Qingdao, China. Diabet Med. 2005 Oct;22(10):1427-33. doi: 10.1111/j.1464-5491.2005.01658.x.
- Background: PubMed 8422770Pan XR, Hu YH, Li GW, Liu PA, Bennett PH, Howard BV. Impaired glucose tolerance and its relationship to ECG-indicated coronary heart disease and risk factors among Chinese. Da Qing IGT and diabetes study. Diabetes Care. 1993 Jan;16(1):150-6. doi: 10.2337/diacare.16.1.150.
- Background: PubMed 9096977Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
- Background: PubMed 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 16391903Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 17192345Jacobs-van der Bruggen MA, Bos G, Bemelmans WJ, Hoogenveen RT, Vijgen SM, Baan CA. Lifestyle interventions are cost-effective in people with different levels of diabetes risk: results from a modeling study. Diabetes Care. 2007 Jan;30(1):128-34. doi: 10.2337/dc06-0690.
- Background: PubMed 19719705Ning F, Pang ZC, Dong YH, Gao WG, Nan HR, Wang SJ, Zhang L, Ren J, Tuomilehto J, Hammar N, Malmberg K, Andersson SW, Qiao Q; Qingdao Diabetes Survey Group. Risk factors associated with the dramatic increase in the prevalence of diabetes in the adult Chinese population in Qingdao, China. Diabet Med. 2009 Sep;26(9):855-63. doi: 10.1111/j.1464-5491.2009.02791.x.
- Derived from this study: PubMed 37529266Ning F, Zhao J, Zhang L, Wang W, Sun X, Song X, Zhang Y, Xin H, Gao W, Gao R, Zhang D, Pang Z. Famine exposure in early life and type 2 diabetes in adulthood: findings from prospective studies in China. Nutr Res Pract. 2023 Aug;17(4):780-788. doi: 10.4162/nrp.2023.17.4.780. Epub 2023 Mar 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Qiao, MD, PhD principal investigator
Department of Public Health, University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Type 2 Diabetes, run by University of Helsinki at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 2 diabetes (time frame: 7-8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053195, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.