Diabetes Prevention Using SMS Technology

Summary

Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent clinical trials have demonstrated that it may be prevented by lifestyle intervention focused on diet and physical activity. These trials have been expensive and labour intensive and this has limited translation of the known benefits to the population at large.

We propose using a mobile phone intervention for lifestyle change and will assess it in a clinical trial(study) in people with impaired glucose regulation (high risk at developing type 2 diabetes).

The study will be conducted in both India and the UK. The purpose of the study is to assess the effectiveness and acceptability of a text messaging system to prevent the progression to diabetes in people with high risk. The study involves five visits to clinic over 2 year period.

Study participants will be divided into two groups by the computer generated random method - one is 'Usual Care' group and the other 'Text Messaging' group.

* Usual care will consist of a 30 minute interview, delivering personalized diet and exercise advice, supplemented by written material and education regarding diabetes. This will be delivered once at the beginning of the study.
* 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 personalized to individual targets set at the initial interview.

The primary outcome will be progression to diabetes, with and without SMS intervention. Secondary outcomes will be improvements in physical activity (reported and directly measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL cholesterol and serum triglycerides).

Conditions

• Prediabetes

Interventions

OTHER

Short text messages

In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.

Sponsors & Collaborators

• Barts & The London NHS Trust

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Lister Hospital

  collaborator UNKNOWN

• Torbay Hospital

  collaborator UNKNOWN

• Queen Alexandra Hospital

  collaborator UNKNOWN

• East Surrey Hospital

  collaborator UNKNOWN

• Pennine Acute Hospitals NHS Trust

  collaborator OTHER

• West Suffolk Hospital

  collaborator UNKNOWN

• Derriford Hospital

  collaborator OTHER

• Exeter Hospital

  collaborator UNKNOWN

• Milton Keynes University Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• Royal Cornwall Hospitals Trust

  collaborator OTHER

• Queen Margaret Hospital, Dunfermline

  collaborator OTHER

• Harrogate & District NHS Foundation Trust

  collaborator OTHER

• Royal Berkshire NHS Foundation Trust

  collaborator OTHER_GOV

• Rotherham NHS Trust

  collaborator UNKNOWN

• Imperial College London

  lead OTHER

Principal Investigators

• Desmond G Johnston, PhD, MB ChB · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-03

Primary Completion

2017-11-30

Completion

2017-11-30

Countries

• United Kingdom

Study Locations