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

December 29, 2015 updated by: Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 008
        • India Diabetes Research Foundation
  • United Kingdom
      • London, United Kingdom, SW1P 3NE
        • Imperial College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women with no history of diabetes

  • 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:

  • Known diabetes
  • Any other illness
  • Unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard Care
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
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%.
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
Time Frame: 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).
Participants will be assessed at 6 month intervals for 2 years.
Improvements in cardiovascular risk factors
Time Frame: Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years.
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
Time Frame: Participants will be assessed at 12-month and 24-month intervals for 2 years.
Quality of life measured by EQ-5D
Participants will be assessed at 12-month and 24-month intervals for 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Collaborators

Indian Council of Medical Research
Imperial College London
Medical Research Council

Investigators

  • Principal Investigator: Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP, President
  • Principal Investigator: Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath, Campus Dean, Imperial College London,Director, UK Diabetes Research Network
  • Principal Investigator: Nicholas J Wareham, MBBS.,M.Sc.Ph.D, Director, MRC Epidemiology Unit and co-Director Institute of Metabolic Science, University of Cambridge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 3, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/1/MRC-ICMR/09/NCD-II_018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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