Use of Information Technology in the Prevention of Diabetes
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|ClinicalTrials.gov Identifier: NCT00819455|
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Experimental Behavioral: Control arm (usual care/standard care arm)||Not Applicable|
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.
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).
Subjects were recruited into two groups:
- control arm: advised on LSM and the beneficial effects of healthy dietary habits, weight reduction and increased physical activity at the baseline, 6, 12, 18 and 24 months respectively (standard care advise).
- Intervention group: receive in addition to the above advise would receive frequent text messages on general well being and different forms of physical activity and principles of healthy diet. The frequency and time at which each participant preferred to receive the messages were noted.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||537 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Information Technology in the Primary Prevention of Type 2 Diabetes|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: 2
In person lifestyle advice at baseline, 6, 12, 18 months.
Behavioral: Control arm (usual care/standard care arm)
Life style modification only once
In person lifestyle advice at baseline, 6, 12, 18 months. Receive reminders by internet based, mobile phone text messaging (Frequency, time and number(s) of messages according to participants requirement)
Active Life style modification-motivation by I.T technology
- Progression to diabetes [ Time Frame: 6 monthly intervals for 2 years ]Prevention of type 2 diabetes in high-risk subjects by lifestyle modification
- Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life [ Time Frame: two years ]
- Acceptability of text messaging as tool to prevent diabetes. [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819455
|Chennai, TamilNadu, India, 600 008|
|Principal Investigator:||Ambady Ramachandran, M.D, D.Sc||President, India Diabetes Research Foundation and Chairman & Managing Director, Dr.A.Ramachandran's Diabetes Hospitals|
|Principal Investigator:||Desmond Geoffrey Johnston, MB Ch B, Ph.D||Professor of Clinical Endocrinology, Imperial College, London|