Use of Information Technology in the Prevention of Diabetes
![]() |
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: NCT00819455 |
Recruitment Status
:
Completed
First Posted
: January 9, 2009
Last Update Posted
: February 15, 2013
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 8, 2009 | ||||||
First Posted Date ICMJE | January 9, 2009 | ||||||
Last Update Posted Date | February 15, 2013 | ||||||
Study Start Date ICMJE | March 2009 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression to diabetes [ Time Frame: 6 monthly intervals for 2 years ] Prevention of type 2 diabetes in high-risk subjects by lifestyle modification
|
||||||
Original Primary Outcome Measures ICMJE |
Reduction in the incidence of diabetes. [ Time Frame: At intervals of six months for two years ] | ||||||
Change History | Complete list of historical versions of study NCT00819455 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life [ Time Frame: two years ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Use of Information Technology in the Prevention of Diabetes | ||||||
Official Title ICMJE | The Role of Information Technology in the Primary Prevention of Type 2 Diabetes | ||||||
Brief Summary | Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it can be prevented in people at high risk by lifestyle intervention. While these trials established the proof of principle, they involved a degree of input from healthcare professionals not feasible outside the trial situation. We hypothesize that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on healthy diet and physical activity habits. We shall develop research protocols and computerized algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere. | ||||||
Detailed Description | Diabetes prevention programmes conducted in various ethnic and racial populations have conclusively demonstrated that lifestyle modification (LSM) focussed on caloric restriction and increased physical activity can prevent or postpone the onset of T2DM. The Indian Diabetes Prevention Programme-1 (IDPP-1) conducted by our group established that LSM is an effective tool for the primary prevention of T2DM in Asian Indian subjects (1). But the major hurdle for any clinical trial is to disseminate the intervention principles at a community level is often proved to be very difficult. The main objective of this prevention programme is to determine whether individualized messages on LSM (diet and physical activity) by mobile phone-based message delivery system can help educate and motivate subjects with a high risk for developing type 2 diabetes to adhere to LSM and thereby improve glucose tolerance. Sample selection: This is a randomized, controlled prospective study, carried out in participants who have been diagnosed with persistent IGT using the 1999 World Health Organization (WHO) criteria. Interested participants who fulfilled the inclusion criteria participated in this prevention programme. Screening was carried out in the work places. The participants were advised not to do any strenuous work during the screening period. Interested participants, after an overnight fast of 8 to 12 hours, underwent a capillary blood glucose test 2h PG after an ingestion of 75G glucose. Among the subjects identified with IGT, those with 2h PG values >8.9 mmol/l (≥ 160 mg/dl) were invited for a confirmatory OGTT, within a week. During the 2nd GTT, venous blood samples were collected at fasting (0 minute), 30 and 120 minutes after the glucose intake.Subjects who satisfied the criteria for IGT on both occasions were recruited for this prevention programme. Randomized was based on the MATLAB 'randperm' random number generator (MARSAGLIA RANDOM NUMBER generator algorithm). Recruitment: Subjects were recruited into two groups:
Assessments: Both groups will undergo personal reviews at 6 monthly intervals for a period of 2 years. At randomization, participants were interviewed personally to elicit demographic, medical, diet, behavioral and physical activity details. 6 & 18 month assessments: Diet and physical activity questionnaires, body weight, WC, pulse and BP will be obtained. Two hour post glucose will be measured. 12 & 24 month assessment: Participants will be questioned about the acceptability of the project and its impact on their life. Changes in health will be documented and the physical examination repeated. They will complete further dietary, physical activity and quality of life questionnaires and will be asked about their use of healthcare resources for health economic assessment. The OGTT and ECG will be repeated, with other measurements as at baseline. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
||||||
Condition ICMJE | Type 2 Diabetes | ||||||
Intervention ICMJE |
|
||||||
Study Arms |
|
||||||
Publications * |
|
||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
537 | ||||||
Original Estimated Enrollment ICMJE |
440 | ||||||
Actual Study Completion Date | November 2012 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 35 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | India | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00819455 | ||||||
Other Study ID Numbers ICMJE | IT001IDRF-IC | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals | ||||||
Study Sponsor ICMJE | India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals | ||||||
Collaborators ICMJE | Imperial College London | ||||||
Investigators ICMJE |
|
||||||
PRS Account | India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals | ||||||
Verification Date | February 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |