Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle counseling
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle counseling<br> | Behavioral: Lifestyle counseling<br>* 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.<br>|
| Active Comparator: Standard care<br> | Behavioral: Standard care<br>* In standard care group, counseling sessions are conducted only 6 times for 4 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Type 2 Diabetes Mellitus | Incidence of type 2 diabetes mellitus | one year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes prevention, Lifestyle modification, Obesity, Impaired glucose tolerance, Diet, Physical activity