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Post Trial Analysis of a Primary Prevention Study in Asian Indians

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ClinicalTrials.gov Identifier: NCT02848547
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 2, 2016
Sponsor:
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

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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

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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.
Criteria

Inclusion Criteria:

Participants of the primary prevention programme - NCT00819455.

Exclusion Criteria:

Unwilling for participation


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov 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