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. (see Contacts and Locations)
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
  Purpose

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).


Condition Intervention
Prediabetic State
Behavioral: Lifestyle Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:

Primary Outcome Measures:
  • 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%.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1050
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570946

Locations
India
India Diabetes Research Foundation Recruiting
Chennai, Tamil Nadu, India, 600 008
Contact: Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP    +91-98410 80605    ramachandran@vsnl.com   
Contact: Snehalatha Chamukuttan, MSc.,D.Phil.,D.Sc    +91 98403 23058    snehalatha@vsnl.com   
Principal Investigator: Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP         
Sub-Investigator: Snehalatha Chamukuttan, M.Sc.,D.Phil.,D.Sc         
Sub-Investigator: Nanditha Arun, MD         
Sub-Investigator: Samith B Shetty, MBBS.,MDRC         
United Kingdom
Imperial College Not yet recruiting
London, United Kingdom, SW1P 3NE
Contact: Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath    +44-0207-886 1209    d.johnston@imperial.ac.uk   
Principal Investigator: Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath         
Sub-Investigator: Nish Chaturvedi, MB.,MRCP.,MFPHM.,MSc.,MD         
Sub-Investigator: Ara Darzi, MB, BCh, BAO, LRCPI, LRCSI,MD         
Sub-Investigator: Nicholas Oliver, MBBS.,MRCP         
Sub-Investigator: Ian F Godsland, PhD.,FIMLS         
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Indian Council of Medical Research
Medical Research Council
Imperial College London
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
  More Information

Publications:
Responsible Party: Dr.A.Ramachandran, President, India Diabetes Research Foundation, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier: NCT01570946     History of Changes
Other Study ID Numbers: 58/1/MRC-ICMR/09/NCD-II_018
Study First Received: March 3, 2012
Last Updated: November 19, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:
Lifestyle changes to prevent type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014