Post Trial Analysis of a Primary Prevention Study in Asian Indians
July 30, 2016 updated by: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study
An extended follow-up study of NCT00819455 conducted 5 years post randomization.
In this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme.
This will provide comparison of the progression to diabetes among group motivated through text messages and the group educated only during enrollment.
A total of 537 participants were enrolled in the primary study and are invited to participate in a follow-up visit 3 years post active trial period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
537
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 63 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants randomized (n=537) in the primary study NCT00819455.
Description
Inclusion Criteria:
Participants of the primary prevention programme - NCT00819455.
Exclusion Criteria:
Unwilling for participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention - SMS
Participants in the intervention group received periodic text messages on healthy lifestyle throughout the study period.
|
|
|
Control - Standard Care
Participants in the control group received standard one time advice at entry in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme.
Time Frame: Two years
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term impact of healthy lifestyle through mobile phone based text messaging
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
July 26, 2016
First Submitted That Met QC Criteria
July 26, 2016
First Posted (Estimate)
July 28, 2016
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
July 30, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- IDRFARH010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.