Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
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

Tracking Information
First Submitted Date July 26, 2016
First Posted Date July 28, 2016
Last Update Posted Date August 2, 2016
Study Start Date January 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2016)
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. [ Time Frame: Two years ]
Original Primary Outcome Measures
 (submitted: July 26, 2016)
To estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. [ Time Frame: Two years ]
Change History Complete list of historical versions of study NCT02848547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 30, 2016)
Long-term impact of healthy lifestyle through mobile phone based text messaging [ Time Frame: Two years ]
Original Secondary Outcome Measures
 (submitted: July 26, 2016)
To compare the long-term impact of healthy lifestyle through mobile phone based text messaging [ Time Frame: Two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Trial Analysis of a Primary Prevention Study in Asian Indians
Official Title The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum and blood cells are stored.
Sampling Method Non-Probability Sample
Study Population Participants randomized (n=537) in the primary study NCT00819455.
Condition Diabetes
Intervention Behavioral: Text Messaging via Short Message Service
Study Groups/Cohorts
  • Intervention - SMS
    Participants in the intervention group received periodic text messages on healthy lifestyle throughout the study period.
    Intervention: 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.
Publications * Nanditha A, Snehalatha C, Raghavan A, Vinitha R, Satheesh K, Susairaj P, Simon M, Selvam S, Ram J, Naveen Kumar AP, Godsland IF, Oliver N, Johnston DG, Ramachandran A. The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention. Diabetes Res Clin Pract. 2018 Aug;142:213-221. doi: 10.1016/j.diabres.2018.05.042. Epub 2018 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2016)
537
Original Actual Enrollment Same as current
Actual Study Completion Date May 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Participants of the primary prevention programme - NCT00819455.

Exclusion Criteria:

Unwilling for participation

Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 63 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02848547
Other Study ID Numbers IDRFARH010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Study Sponsor India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators Not Provided
Investigators Not Provided
PRS Account India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Verification Date July 2016