Working… Menu

Post Trial Analysis of a Primary Prevention Study in Asian Indians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02848547
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 2, 2016
Information provided by (Responsible Party):
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Brief 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.

Condition or disease Intervention/treatment
Diabetes Behavioral: Text Messaging via Short Message Service

Layout table for study information
Study Type : Observational
Actual Enrollment : 537 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study
Study Start Date : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Intervention - SMS
Participants in the intervention group received periodic text messages on healthy lifestyle throughout the study period.
Behavioral: Text Messaging via Short Message Service
Control - Standard Care
Participants in the control group received standard one time advice at entry in the study.

Primary Outcome Measures :
  1. Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Long-term impact of healthy lifestyle through mobile phone based text messaging [ Time Frame: Two years ]

Biospecimen Retention:   Samples With DNA
Serum and blood cells are stored.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants randomized (n=537) in the primary study NCT00819455.

Inclusion Criteria:

Participants of the primary prevention programme - NCT00819455.

Exclusion Criteria:

Unwilling for participation

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals Identifier: NCT02848547     History of Changes
Other Study ID Numbers: IDRFARH010
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided