Use of Information Technology in the Prevention of Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Experimental; Control arm (usual care/standard care arm)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active Life style modification-motivation by I.T technology; Life style modification only once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Prevention of Diabetes; Lifestyle Modification; Text messages