Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

NCT ID: NCT01085682

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

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 type 2 diabetes mellitus, 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 impaired glucose tolerance 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Group Type: ACTIVE_COMPARATOR

Lifestyle counseling

Intervention Type: BEHAVIORAL

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.

Standard care

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

In standard care group, counseling sessions are conducted only 6 times for 4 years

Interventions

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.

Intervention Type: BEHAVIORAL

Standard care

In standard care group, counseling sessions are conducted only 6 times for 4 years

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age of 30-69 years
• BMI ≥ 20 kg/m2
• Impaired glucose tolerance :

2h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose : Fasting plasma glucose 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Kun-Ho Yoon

Professor, Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kun-Ho Yoon, M.D., Ph.D.

Role: STUDY_DIRECTOR

Kangnam St.Mary's hospital

Locations

Chung-ju health care center

Chungju, Chungchungbook-do, South Korea

Countries

South Korea

Other Identifiers

KCMC07OT255

Identifier Type: -

Identifier Source: org_study_id