Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

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).

Official Title
-----------------
A Pragmatic and Scalable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Conditions
-----------------
Prediabetic State

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification<br>The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation. | Behavioral: Lifestyle Modification<br>* The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.<br>|
| No Intervention: Standard Care<br>Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to diabetes | The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%. | Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in physical activity | 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). | Participants will be assessed at 6 month intervals for 2 years. | 
| Improvements in cardiovascular risk factors | Measurement of insulin and lipid levels | Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years. | 
| Improvements in Quality of Life | Quality of life measured by EQ-5D | Participants will be assessed at 12-month and 24-month intervals for 2 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lifestyle changes to prevent type 2 diabetes