Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
NCT01570946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1171
Last updated 2015-12-30
Summary
Primary prevention of diabetes is of paramount importance in both developed and in developing countries. Several studies including the Indian Diabetes Prevention Programmes have shown that Lifestyle modification in people with prediabetes can reduce the progression to diabetes by 58%. However, there are two main problems in applying diabetes prevention strategies to the population as a whole. (1) Trial based interventions are unrealistic on a population level in any country. (2) The oral glucose tolerance test applied so far to identify those at high risk is a poorly reproducible and time consuming test both for the participant and for health care workers. Hence more practical means of defining individuals who would benefit from lifestyle intervention are required.
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).
Conditions
- Prediabetic State
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Indian Council of Medical Research
collaborator OTHER_GOV - collaborator OTHER_GOV
-
Imperial College London
collaborator OTHER -
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
lead OTHER
Principal Investigators
-
Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP · President
-
Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath · Campus Dean, Imperial College London,Director, UK Diabetes Research Network
-
Nicholas J Wareham, MBBS.,M.Sc.Ph.D · Director, MRC Epidemiology Unit and co-Director Institute of Metabolic Science, University of Cambridge
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-12-31
Countries
- India
- United Kingdom
Study Locations
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