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NCT Number: NCT01570946

Use of 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).

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Key information

Conditions

Prediabetic State Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

India Diabetes Research Foundation, Chennai, Tamil Nadu, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Modification

Behavioral

The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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).

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Imperial College London
  • Indian Council of Medical Research
  • Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2012
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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