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Use of Information Technology in the Prevention of Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Experimental
Control arm (usual care/standard care arm)
Sponsored by
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Diabetes, Prevention of Diabetes, Lifestyle Modification, Text messages

Eligibility Criteria

35 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Dr.Ambady Ramachandran

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

In person lifestyle advice at baseline, 6, 12, 18 months.

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)

Outcomes

Primary Outcome Measures

Progression to diabetes
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
Acceptability of text messaging as tool to prevent diabetes.

Full Information

First Posted
January 8, 2009
Last Updated
February 13, 2013
Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00819455
Brief Title
Use of Information Technology in the Prevention of Diabetes
Official Title
The Role of Information Technology in the Primary Prevention of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Prevention of Diabetes, Lifestyle Modification, Text messages

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
In person lifestyle advice at baseline, 6, 12, 18 months.
Arm Title
1
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Experimental
Intervention Description
Active Life style modification-motivation by I.T technology
Intervention Type
Behavioral
Intervention Name(s)
Control arm (usual care/standard care arm)
Intervention Description
Life style modification only once
Primary Outcome Measure Information:
Title
Progression to diabetes
Description
Prevention of type 2 diabetes in high-risk subjects by lifestyle modification
Time Frame
6 monthly intervals for 2 years
Secondary Outcome Measure Information:
Title
Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life
Time Frame
two years
Title
Acceptability of text messaging as tool to prevent diabetes.
Time Frame
Two years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambady Ramachandran, M.D, D.Sc
Organizational Affiliation
President, India Diabetes Research Foundation and Chairman & Managing Director, Dr.A.Ramachandran's Diabetes Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desmond Geoffrey Johnston, MB Ch B, Ph.D
Organizational Affiliation
Professor of Clinical Endocrinology, Imperial College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Ambady Ramachandran
City
Chennai
State/Province
TamilNadu
ZIP/Postal Code
600 008
Country
India

12. IPD Sharing Statement

Citations:
Citation
Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49:289-97. PMID: 16391903 Snehalatha C, Mary S, Joshi VV, Ramachandran A. Beneficial effects of strategies for primary prevention of diabetes on cardiovascular risk factors: results of the Indian Diabetes Prevention Programme. Diab Vasc Dis Res. 2008 Mar;5:25-9. PMID: 18398809 Murugesan N, Snehalatha C, Shobhana R, Roglic G, Ramachandran A. Awareness about diabetes and its complications in the general and diabetic population in a city in southern India. Diabetes Res Clin Pract. 2007 Sep;77:433-7. PMID: 17291622 Ramachandran A, Mary S, Yamuna A, Murugesan N, Snehalatha C. High prevalence of diabetes and cardiovascular risk factors associated with urbanization in India. Diabetes Care. 2008 May;31:893-8. PMID: 18310309 Ramachandran A. Epidemiology of diabetes in India--three decades of research. J Assoc Physicians India. 2005 Jan;53:34-8. Review. PMID: 15857011
Results Reference
background
PubMed Identifier
26281475
Citation
Nanditha A, Jagannathan R, Sundaram S, Susairaj P, Shetty AS, Snehalatha C, Ian GF, Johnston DG, Ramachandran A. Combining Fasting Plasma Glucose with Gamma-glutamyl Transferase Improves the Sensitivity to Predict Incident Diabetes in Asian Indian Men with Impaired Glucose Tolerance. J Assoc Physicians India. 2014 Nov;62(11):18-22.
Results Reference
derived
PubMed Identifier
25458326
Citation
Ram J, Selvam S, Snehalatha C, Nanditha A, Simon M, Shetty AS, Godsland IF, Johnston DG, Ramachandran A. Improvement in diet habits, independent of physical activity helps to reduce incident diabetes among prediabetic Asian Indian men. Diabetes Res Clin Pract. 2014 Dec;106(3):491-5. doi: 10.1016/j.diabres.2014.09.043. Epub 2014 Oct 25.
Results Reference
derived
PubMed Identifier
25216506
Citation
Nanditha A, Ram J, Snehalatha C, Selvam S, Priscilla S, Shetty AS, Arun R, Godsland IF, Johnston DG, Ramachandran A. Early improvement predicts reduced risk of incident diabetes and improved cardiovascular risk in prediabetic Asian Indian men participating in a 2-year lifestyle intervention program. Diabetes Care. 2014 Nov;37(11):3009-15. doi: 10.2337/dc14-0407. Epub 2014 Sep 11.
Results Reference
derived
PubMed Identifier
25190675
Citation
Hughes RC, Moore MP, Gullam JE, Mohamed K, Rowan J. An early pregnancy HbA1c >/=5.9% (41 mmol/mol) is optimal for detecting diabetes and identifies women at increased risk of adverse pregnancy outcomes. Diabetes Care. 2014 Nov;37(11):2953-9. doi: 10.2337/dc14-1312. Epub 2014 Sep 4.
Results Reference
derived
PubMed Identifier
24622367
Citation
Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.
Results Reference
derived

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Use of Information Technology in the Prevention of Diabetes

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