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Sponsors and Collaborators: |
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals Imperial College, United Kingdom- India Education and Research Intiative(UKIERI, World Diabetes Foundation |
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Information provided by: | India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals |
ClinicalTrials.gov Identifier: | NCT00819455 |
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 hypothesise that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on body weight, diet and physical activity. We shall develop research protocols and computerised algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere.
Condition | Intervention |
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Type 2 Diabetes |
Behavioral: Experimental Behavioral: Control arm (usual care/standard care arm) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Information Technology in the Prevention of Type 2 Diabetes |
Estimated Enrollment: | 440 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Life style advice only once(Conventional life style advice)
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Behavioral: Control arm (usual care/standard care arm)
Life style modification only once
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1: Experimental
Active Life Style Modification
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Behavioral: Experimental
Active Life style modification-motivation by I.T technology
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The project will begin with the diabetes awareness campaign, using posters and pamphlets designed for the Indian population. Following implementation of the awareness campaign in selected workplace, employees will be selected for the prevention programme if they fulfil the following criteria: body mass index ≥ 23; age ≥ 35 years; a 1st degree relative with type 2 diabetes; and absence of other illness. The eligible subjects will undergo an OGTT with samples for glucose estimation at 0 and 2 hours. If the 2-hour plasma glucose level is > 7.8 - <11.1 mmol/l and/or the fasting glucose is >6.1 - <7.0 mmol/l, they will be selected for the project.
Participants will undergo randomization to either; the intervention group which will receive individualized feedback on lifestyle modification (diet and physical activity) by mobile phone or using their home computer; a control group which will receive conventional lifestyle advice.
The intervention group will be offered a mobile phone for the duration of the study (24 months). Their phone contract will be paid and payment will be provided for all calls and SMS messages sent or received for the purposes of the project. SMS messages will be sent each week and participants will be contacted monthly by voice, at times convenient to them, to discuss their progress and compliance with the behavioural modification. At 3 months, the participants in the intervention group will be contacted by phone and asked their views as to the frequency and mode of contact (SMS, voice contact or email). The advice will then be further individualized. The intervention group will have contact numbers for the investigators and may call or text at any time. The investigators will reply to messages within 48 hrs.
The participants will be seen baseline and at 6, 12, 18 and 24 months. Baseline assessments: Subjects will have a personal interview, complete a short health questionnaire and undergo a brief physical examination (including body weight, fat%,height, waist circumference, heart rate and blood pressure). They will complete questionnaires on diet and physical activity, quality of life and health care usage. A fasting blood sample will be taken for measurement of glucose, total and HDL-cholesterol, triglyceride, insulin, liver function, uric acid and other cardiovascular risk factors. An OGTT will be performed with samples for glucose and insulin estimation at 30 and 120 minutes. An ECG will be performed.
6 & 18 month assessments: Diet and physical activity questionnaires, body weight, WC, pulse and BP will be obtained. Two hour post prandial capillary 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.
Ages Eligible for Study: | 35 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ambady Ramachandran, M.D, D.Sc | +91-44-28582003/04/05 ext 233 | ramachandran@ardiabetes.org |
Contact: Chamakuttan Snehalatha, M.Sc, D.Sc | +91-44-28582003/04/05 ext 233 | snehalatha@vsnl.com |
India, TamilNadu | |
Dr.Ambady Ramachandran | |
Chennai, TamilNadu, India, 600 008 | |
Dr.Ambady Ramachandran | |
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 |
Study Director: | Shaukat Sadikot, Doctor | President, Diabetes India, 308, Doctor House, Peddar Road, Mumbai-400026, India |
Study Director: | Chittaranjan Sakerlal Yagnik, Doctor | Director, Diabetes Unit, King Edward Memorial Hospital, Rastapet, Pune 411011, India |
Responsible Party: | Dr.A.Ramachandran, President and Prof. Desmond Geoffrey Johnston, Professor of Clinical Endocrinology ( Dr.A.Ramachandran, President and Prof. Desmond Geoffrey Johnston, Professor of Clinical Endocrinology ) |
Study ID Numbers: | IT001IDRF-IC |
Study First Received: | January 8, 2009 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00819455 |
Health Authority: | India: Institutional Review Board |
Diabetes Prevention of Diabetes Life Style Modification Primary Prevention |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |