Clinical Trials Directory

Trials / Completed

CompletedNCT01085682

Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
59 (actual)
Sponsor
The Catholic University of Korea · Academic / Other
Sex
All
Age
30 Years – 69 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALLifestyle counselingIn 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.
BEHAVIORALStandard careIn standard care group, counseling sessions are conducted only 6 times for 4 years

Timeline

Start date
2008-01-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2010-03-12
Last updated
2014-09-12
Results posted
2014-09-12

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01085682. Inclusion in this directory is not an endorsement.