Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
NCT ID: NCT01570946
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1171 participants
INTERVENTIONAL
2012-05-31
2015-12-31
Brief Summary
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The current study proposes a prevention strategy that will employ a lifestyle modification programme delivered by text messaging in both India and the UK.Subjects will be identified based on the HbA1c measurement instead of the oral glucose tolerance test. The study will also assess the efficacy, acceptability and cost effectiveness of mobile phone based intervention both in India and the UK.
Messages will be based to deliver education, treatment targets, advice, support and motivation. Subjects will be invited to participate and, once recruited, will be randomised to usual care or the SMS intervention group.
Usual care will consist of a one-to-one 30 minute interview, conducted by the research team, delivering personalised diet and exercise advice.
The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalised to individual targets set at the initial interview.
Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity / Cardiovascular risk factors/and quality of life.
The study programme is compatible with major initiatives in both the UK and India for the prevention of diabetes and cardiovascular disease (CVD).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lifestyle modification
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Lifestyle Modification
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Standard Care
Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.
No interventions assigned to this group
Interventions
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Lifestyle Modification
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Eligibility Criteria
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Inclusion Criteria
* Persons with 2 or more risk factors including
1. Age 35-55 years
2. Positive family history of diabetes
3. Body mass index ≥23kg/m2
4. Waist circumference \>90cm for men and \>80cm for women
5. Hypertension
6. Sedentary habits
* HbA1c 6.0% - \<6.5%
Exclusion Criteria
* Any other illness
* Unwilling to participate
35 Years
55 Years
ALL
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
Medical Research Council
OTHER_GOV
Imperial College London
OTHER
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
OTHER
Responsible Party
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Dr.A.Ramachandran
President, India Diabetes Research Foundation
Principal Investigators
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Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP
Role: PRINCIPAL_INVESTIGATOR
President
Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath
Role: PRINCIPAL_INVESTIGATOR
Campus Dean, Imperial College London,Director, UK Diabetes Research Network
Nicholas J Wareham, MBBS.,M.Sc.Ph.D
Role: PRINCIPAL_INVESTIGATOR
Director, MRC Epidemiology Unit and co-Director Institute of Metabolic Science, University of Cambridge
Locations
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India Diabetes Research Foundation
Chennai, Tamil Nadu, India
Imperial College
London, , United Kingdom
Countries
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References
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Ramachandran A, Snehalatha C, Samith Shetty A, Nanditha A. Predictive value of HbA1c for incident diabetes among subjects with impaired glucose tolerance--analysis of the Indian Diabetes Prevention Programmes. Diabet Med. 2012 Jan;29(1):94-8. doi: 10.1111/j.1464-5491.2011.03392.x.
Shetty AS, Chamukuttan S, Nanditha A, Raj RK, Ramachandran A. Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)--a pilot study. J Assoc Physicians India. 2011 Nov;59:711-4.
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(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.
Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, Shetty AS. Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2). Diabetologia. 2009 Jun;52(6):1019-26. doi: 10.1007/s00125-009-1315-x. Epub 2009 Mar 10.
Ramachandran A, Snehalatha C, Yamuna A, Mary S, Ping Z. Cost-effectiveness of the interventions in the primary prevention of diabetes among Asian Indians: within-trial results of the Indian Diabetes Prevention Programme (IDPP). Diabetes Care. 2007 Oct;30(10):2548-52. doi: 10.2337/dc07-0150. Epub 2007 Aug 1.
Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. doi: 10.2337/dc11-1918. Epub 2012 Feb 8.
Nanditha A, Thomson H, Susairaj P, Srivanichakorn W, Oliver N, Godsland IF, Majeed A, Darzi A, Satheesh K, Simon M, Raghavan A, Vinitha R, Snehalatha C, Westgate K, Brage S, Sharp SJ, Wareham NJ, Johnston DG, Ramachandran A. A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial. Diabetologia. 2020 Mar;63(3):486-496. doi: 10.1007/s00125-019-05061-y. Epub 2020 Jan 9.
Thomson H, Oliver N, Godsland IF, Darzi A, Srivanichakorn W, Majeed A, Johnston DG, Nanditha A, Snehalatha C, Raghavan A, Susairaj P, Simon M, Satheesh K, Ramachandran A, Sharp S, Westgate K, Brage S, Wareham N. Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK. BMC Endocr Disord. 2018 Sep 10;18(1):63. doi: 10.1186/s12902-018-0293-8.
Other Identifiers
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58/1/MRC-ICMR/09/NCD-II_018
Identifier Type: -
Identifier Source: org_study_id