Trial Outcomes & Findings for Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program (NCT NCT01085682)
NCT ID: NCT01085682
Last Updated: 2014-09-12
Results Overview
Incidence of type 2 diabetes mellitus
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
one year follow up
Results posted on
2014-09-12
Participant Flow
Participant milestones
| Measure |
Lifestyle Counseling
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
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
28
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
Reasons for withdrawal
| Measure |
Lifestyle Counseling
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
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
25
|
Baseline Characteristics
Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Baseline characteristics by cohort
| Measure |
Lifestyle Counseling
n=6 Participants
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
n=3 Participants
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 3 • n=93 Participants
|
55 years
STANDARD_DEVIATION 3 • n=4 Participants
|
55 years
STANDARD_DEVIATION 3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: one year follow upIncidence of type 2 diabetes mellitus
Outcome measures
| Measure |
Lifestyle Counseling
n=6 Participants
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
n=3 Participants
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
|
|---|---|---|
|
Incidence of Type 2 Diabetes Mellitus
|
1 participants
|
1 participants
|
Adverse Events
Lifestyle Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kun-Ho Yoon, professor
The Catholic University of Korea
Phone: 82-2-2258-8281
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place