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Trial record 44 of 661 for:    applied AND web-

Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

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ClinicalTrials.gov Identifier: NCT01085682
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Kun-Ho Yoon, The Catholic University of Korea

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Type 2 Diabetes
Interventions Behavioral: Lifestyle counseling
Behavioral: Standard care
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lifestyle Counseling Standard Care
Hide Arm/Group Description 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. Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
Period Title: Overall Study
Started 31 28
Completed 6 3
Not Completed 25 25
Reason Not Completed
Withdrawal by Subject             25             25
Arm/Group Title Lifestyle Counseling Standard Care Total
Hide Arm/Group Description 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. Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years Total of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
55  (3) 55  (3) 55  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
2
  33.3%
1
  33.3%
3
  33.3%
Male
4
  66.7%
2
  66.7%
6
  66.7%
1.Primary Outcome
Title Incidence of Type 2 Diabetes Mellitus
Hide Description Incidence of type 2 diabetes mellitus
Time Frame one year follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling Standard Care
Hide Arm/Group Description:
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.
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Counseling Standard Care
Hide Arm/Group Description 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. Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
All-Cause Mortality
Lifestyle Counseling Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lifestyle Counseling Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lifestyle Counseling Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kun-Ho Yoon, professor
Organization: The Catholic University of Korea
Phone: 82-2-2258-8281
Responsible Party: Kun-Ho Yoon, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01085682     History of Changes
Other Study ID Numbers: KCMC07OT255
First Submitted: February 19, 2010
First Posted: March 12, 2010
Results First Submitted: September 8, 2014
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014