Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
- Conditions
- Prediabetic State
- Interventions
- Behavioral: Lifestyle Modification
- Registration Number
- NCT01570946
- Lead Sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1171
-
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%
- Known diabetes
- Any other illness
- Unwilling to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle modification 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.
- Primary Outcome Measures
Name Time Method Progression to diabetes 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 Outcome Measures
Name Time Method Improvements in cardiovascular risk factors Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years. Measurement of insulin and lipid levels
Improvements in Quality of Life Participants will be assessed at 12-month and 24-month intervals for 2 years. Quality of life measured by EQ-5D
Improvements in physical activity Participants will be assessed at 6 month intervals for 2 years. Improvement in physical activity defined as minutes per day of moderate-to-vigorous physical activity (MVPA) measured by Actigraph, total and domain-specific physical activity measured by Recent Physical Activity Questionnaire (RPAQ).
Trial Locations
- Locations (2)
India Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Imperial College
🇬🇧London, United Kingdom