A Pragmatic and Scalable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,171
- Locations
- 4
- Primary Endpoint
- Progression to diabetes
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women with no history of diabetes
- •Persons with 2 or more risk factors including
- •Age 35-55 years
- •Positive family history of diabetes
- •Body mass index ≥23kg/m2
- •Waist circumference >90cm for men and >80cm for women
- •Hypertension
- •Sedentary habits
- •HbA1c 6.0% - <6.5%
Exclusion Criteria
- •Known diabetes
- •Any other illness
- •Unwilling to participate
Outcomes
Primary Outcomes
Progression to diabetes
Time Frame: Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years.
The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%.
Secondary Outcomes
- Improvements in cardiovascular risk factors(Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years.)
- Improvements in Quality of Life(Participants will be assessed at 12-month and 24-month intervals for 2 years.)
- Improvements in physical activity(Participants will be assessed at 6 month intervals for 2 years.)
Investigators
Dr.A.Ramachandran
President, India Diabetes Research Foundation
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals