Use of Information Technology in the Prevention of Diabetes

This study has been completed.
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier:
NCT00819455
First received: January 8, 2009
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Experimental
Behavioral: Control arm (usual care/standard care arm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Role of Information Technology in the Primary Prevention of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:

Primary Outcome Measures:
  • Progression to diabetes [ Time Frame: 6 monthly intervals for 2 years ] [ Designated as safety issue: Yes ]
    Prevention of type 2 diabetes in high-risk subjects by lifestyle modification


Secondary Outcome Measures:
  • Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Acceptability of text messaging as tool to prevent diabetes. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 537
Study Start Date: March 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
Behavioral: Experimental
Active Life style modification-motivation by I.T technology

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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819455

Locations
India
Dr.Ambady Ramachandran
Chennai, TamilNadu, India, 600 008
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Imperial College London
Investigators
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
  More Information

Additional Information:
No publications provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.A.Ramachandran, President, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier: NCT00819455     History of Changes
Other Study ID Numbers: IT001IDRF-IC
Study First Received: January 8, 2009
Last Updated: February 13, 2013
Health Authority: India: Institutional Review Board

Keywords provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:
Diabetes
Prevention of Diabetes
Lifestyle Modification
Text messages

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014