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

This study is currently recruiting participants.
Verified November 2012 by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Sponsor:
Collaborators:
Indian Council of Medical Research
Medical Research Council
Imperial College London
Information provided by (Responsible Party):
Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier:
NCT01570946
First received: March 3, 2012
Last updated: November 19, 2012
Last verified: November 2012

March 3, 2012
November 19, 2012
May 2012
September 2014   (final data collection date for primary outcome measure)
Progression to diabetes [ Time Frame: Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years. ] [ Designated as safety issue: No ]
The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%.
Same as current
Complete list of historical versions of study NCT01570946 on ClinicalTrials.gov Archive Site
  • Improvements in physical activity [ Time Frame: Participants will be assessed at 6 month intervals for 2 years. ] [ Designated as safety issue: No ]
    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).
  • Improvements in cardiovascular risk factors [ Time Frame: Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years. ] [ Designated as safety issue: No ]
    Measurement of insulin and lipid levels
  • Improvements in Quality of Life [ Time Frame: Participants will be assessed at 12-month and 24-month intervals for 2 years. ] [ Designated as safety issue: No ]
    Quality of life measured by EQ-5D
Same as current
Not Provided
Not Provided
 
Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prediabetic State
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.
  • 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.
    Intervention: Behavioral: Lifestyle Modification
  • No Intervention: Standard Care
    Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1050
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
35 Years to 55 Years
No
Not Provided
India,   United Kingdom
 
NCT01570946
58/1/MRC-ICMR/09/NCD-II_018
Yes
Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
  • Indian Council of Medical Research
  • Medical Research Council
  • Imperial College London
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
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP