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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
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

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
 (submitted: January 25, 2013)
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
 (submitted: January 8, 2009)
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
 (submitted: February 13, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life [ Time Frame: two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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:

  1. 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).
  2. 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.

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  ICMJE 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
  • Behavioral: Experimental
    Active Life style modification-motivation by I.T technology
  • Behavioral: Control arm (usual care/standard care arm)
    Life style modification only once
Study Arms  ICMJE
  • Active Comparator: 2
    In person lifestyle advice at baseline, 6, 12, 18 months.
    Intervention: Behavioral: Control arm (usual care/standard care arm)
  • Experimental: 1
    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)
    Intervention: Behavioral: Experimental
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
 (submitted: June 24, 2011)
537
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
440
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index ≥ 23
  • Age ≥ 35 years
  • A 1st degree relative with type 2 diabetes

Exclusion Criteria:

  • Normal and diabetic subjects
  • Presence of other serious illness
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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
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
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