NCT01053195

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276,793

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

10 years

First QC Date

January 19, 2010

Last Update Submit

August 25, 2016

Conditions

Type 2 Diabetes

Keywords

Diabetespreventionintervention

Outcome Measures

Primary Outcomes (1)

  • Incidence of type 2 diabetes

    7-8 years

Secondary Outcomes (1)

  • Cost-effectiveness of the lifestyle intervention

    7-8 years

Study Arms (2)

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.

Behavioral: Lifestyle counseling

Control

NO INTERVENTION

No intervention activity will be assigned for participants enrolled from the control areas.

Interventions

Lifestyle counselingBEHAVIORAL

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.

Lifestyle counseling

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals Aged 35 years or older
  • individuals at high risk for diabetes identified by a risk score assessment
  • individuals with baseline measurement of glucose

You may not qualify if:

  • individuals with a prior history of diabetes or taking antidiabetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Municipal Center for Disease Control & Prevention

Qingdao, Shandong, 266033, China

Location

Related Publications (9)

  • 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.

    PMID: 16176207BACKGROUND

  • Pan 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.

    PMID: 8422770BACKGROUND

  • Pan 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.

    PMID: 9096977BACKGROUND

  • Tuomilehto 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.

    PMID: 11333990BACKGROUND

  • Ramachandran 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.

    PMID: 16391903BACKGROUND

  • Knowler 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.

    PMID: 11832527BACKGROUND

  • Jacobs-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.

    PMID: 17192345BACKGROUND

  • Ning 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.

    PMID: 19719705BACKGROUND

  • Ning 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.

    PMID: 37529266DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Qing Qiao, MD, PhD

    Department of Public Health, University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

December 1, 2005

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

CN(1)