Post Trial Analysis of a Primary Prevention Study in Asian Indians
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| ClinicalTrials.gov Identifier: NCT02848547 |
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Recruitment Status :
Completed
First Posted : July 28, 2016
Last Update Posted : August 2, 2016
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Sponsor:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
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 |
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. [ Time Frame: Two years ] | ||
| Original Primary Outcome Measures |
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 |
Long-term impact of healthy lifestyle through mobile phone based text messaging [ Time Frame: Two years ] | ||
| Original Secondary Outcome Measures |
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 |
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| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Retention: Samples With DNA Description: Serum and blood cells are stored.
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| 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 |
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| 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. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
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 |
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| Sex/Gender |
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| 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 |
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| 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 | ||