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NCT02848547 Clinical Trial

Post Trial Analysis of a Primary Prevention Study in Asian Indians

Diabetes Clinical Trial

Official title:
The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02848547
Other study ID # IDRFARH010
Secondary ID
Status Completed
Phase N/A
First received July 26, 2016
Last updated July 30, 2016
Start date January 2016
Est. completion date May 2016

Study information
Verified date July 2016
Source India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 537
Est. completion date May 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 63 Years
Eligibility Inclusion Criteria:

Participants of the primary prevention programme - NCT00819455.

Exclusion Criteria:

Unwilling for participation

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Behavioral:
• Text Messaging via Short Message Service

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. Two years No
Secondary Long-term impact of healthy lifestyle through mobile phone based text messaging Two years No
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