Text Size

Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01085682
First received: February 19, 2010
Last updated: March 11, 2010
Last verified: December 2007
History of Changes
  Purpose

This study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.


Condition Intervention Phase
Type 2 Diabetes
 Behavioral: Lifestyle counseling
Behavioral: Standard care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • The incidence rate of diabetes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome measure is the incidence rate of diabetes between trial group and comparison group


Secondary Outcome Measures:
  • Number of participants who met weight loss with a goal 5% of initial weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Exercising a minimum of 150 minutes per week at a moderate level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week

  • Insulin resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Lipids : Total cholesterol, HDL-cholesterol, LDL-cholesterol and Triglyceride

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The evaluation of cost-effectiveness of the web-based diabetes prevention program


Estimated Enrollment: 320
Study Start Date: January 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling Behavioral: Lifestyle counseling
In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
Active Comparator: Standard care Behavioral: Standard care
In standard care group, counseling sessions are conducted only 6 times for 4 years

Detailed Description:

Diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and physical inactivity in Korea. Many studies reported that lifestyle modification related in the primary prevention of diabetes in multiethnic populations. The aim of this study is to determine whether internet-based interventions in those at high risk may delay the development of T2DM, and thereby reduce the incidence of cardiovascular diseases and strokes in Korean populations. In January 2008, participant recruitment began in Chung-ju city, a rural area in Korea. The subjects with IGT or elevated fasting plasma glucose concentrations were selected from initial screening and then randomized to either a control or intensive lifestyle group to carry out intervention over 4 years. The primary outcome of this study is the development of diabetes by ADA criteria. To confirm the onset of diabetes, all subjects have an OGTT at the interim 6-month and each annual visit. Also, systematic evaluation examination will be done at the same time. The proportion of subjects developing diabetes in each group and the factors relating the progression will be estimated using statistical analysis.

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of 30-69 years
  • BMI ≥ 20 kg/m2
  • IGT : 2h PG(75 g OGTT) 140-199 mg/dl or IFG : FPG 110-125 mg/dl

Exclusion Criteria:

  • Diabetes at baseline
  • Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
  • Unable to communicate with clinic staff, Pregnancy and childbearing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085682

Contacts
Contact: Kun-Ho Yoon, M.D., Ph.D. 82-2-2258-6007 yoonk@catholic.ac.kr

Locations
Korea, Republic of
Chung-ju health care center Recruiting
Chung-ju, Chungchungbook-do, Korea, Republic of
Contact: Seung D Shin, RN     82-43-850-7349     ssdeug@naver.com    
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Director: Kun-Ho Yoon, M.D., Ph.D. Kangnam St.Mary's hospital
  More Information

No publications provided

Responsible Party: Kun-Ho Yoon, Seoul St.Mary's hospital
ClinicalTrials.gov Identifier: NCT01085682     History of Changes
Other Study ID Numbers: KCMC07OT255
Study First Received: February 19, 2010
Last Updated: March 11, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Diabetes prevention
Lifestyle modification
Obesity
 Impaired glucose tolerance
Diet
Physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013