A Pragmatic and Scaleable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
Phase: NA
Conditions: Prediabetes
Sponsor: Imperial College London

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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CLINICAL TRIAL PROTOCOL 
 
 
A pragmatic and scaleable strategy using mobile technology to 
promote sustained lifestyle changes to Prevent Type 2 Diabetes in 
India and the UK 
Chief Investigator: Professor D Johnston 
 
 
General Information 
 
Authors:  
 
 
Professor D Johnston, Dr N Oliver 
Title:  
A pragmatic and scaleable strategy using mobile technology to 
promote sustained lifestyle changes to Prevent Type 2 
Diabetes in India and the UK 
 
Identifying Number:  
Imperial College Joint Research Office CRO1999 
 
 
 
Sponsor: 
 
 
Joint Research Compliance Office 
 
 
 
 
Imperial College London and Imperial College Healthcare NHS Trust, 
 
 
 
 
Charing Cross Hospital, 
 
 
 
 
London, 
 
 
 
 
W6 8RF 
 
Sponsor Contact: 
 
Ruth Nicholson 
Research Governance Manager 
 
 
 
 
Joint Research Compliance Office 
 
 
 
 
Imperial College London and Imperial College Healthcare NHS Trust, 
 
 
 
 
Charing Cross Hospital, 
 
 
 
 
London, W6 8RF 
 
 
 
 
r.nicholson@imperial.ac.uk 
 
 
 
 
 
 
Principal Investigator: 
Professor D Johnston, 
 
 
 
 
St. Mary’s Hospital Medical School Building, 
 
 
 
 
Imperial College, 
 
 
 
 
London, 
 
 
 
 
W2 1NY 
 
 
 
 
d.johnston@imperial.ac.uk 
 
 
 
 
0207 594 2429 
 
 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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Background The current burden of diabetes in both India and the UK is high and it is 
expected to increase over the next 20 years. In India, the problem is especially bad with a 
prevalence in adults of 20% in urban and 10% in rural populations1. In the UK, 5% of the 
population is known to have diabetes2. Sub-groups can be defined to be at high risk of 
developing diabetes, especially those with impaired glucose regulation (IGR) historically 
defined on the results of an oral glucose tolerance test (OGTT). In India the prevalence of 
IGR is 18% of the adult population, again with an urban/rural split, and in the UK, the figure 
is 15% with higher values in those of Indian ethnic origin. Some people with IGR will revert to 
normal glucose tolerance but progression rates to diabetes are 4-9% per year in published 
series3,4. Several clinical trials, including the Indian Diabetes Prevention Program (IDPP), 
have shown that intensive lifestyle modification in people with IGR can reduce the 
progression to diabetes by up to 58%5-8. 
There are 2 main challenges in applying diabetes prevention strategies to the population as 
a whole. Firstly, the lifestyle modification interventions employed in clinical trials are labour 
intensive and expensive (the US Diabetes Prevention Program8, for example, cost over 
$200million) and such trial-based interventions are unrealistic on a population level in any 
country. Secondly, the OGTT used to identify those in the population at high risk is a poorly 
reproducible and time-consuming test, both for the participant and for health care workers. 
More practical means of defining individuals who would benefit from lifestyle intervention are 
required. 
We propose more practical solutions to these two issues. Firstly, our diabetes prevention 
strategy will employ a lifestyle modification programme delivered by text messaging in both 
India and the UK. Text messaging has been successfully used to modify behaviour in other 
contexts and the current proposal will assess the efficacy, acceptability and cost 
effectiveness of mobile phone based lifestyle intervention in IGR in India and the UK. The 
primary outcome will be progression to diabetes. Secondary outcomes will be physical 
activity, other cardiovascular disease (CVD) risk factors and quality of life. An economic 
analysis will be performed. Secondly, we propose to employ HbA1c measurement instead of 
the OGTT as the basis for intervention. This has the advantage of a single sample taken 
non-fasting. It reflects average circulating glucose levels over the preceding 4-8 weeks and 
has similar biological significance (in terms of the complications of diabetes) to that of OGTT 
glucose values. Since standardisation by the International Federation of Clinical Chemistry 
(IFCC), it has been recognised as a diagnostic test for diabetes by the American Diabetes 
Association (ADA), the European Association for the Study of Diabetes (EASD) and the 
International Diabetes Federation (IDF), with a cut-off at 6.5%9. For impaired glucose 
regulation, the ADA has recommended the HbA1c range of 5.7-6.4%9. International 
consensus has not yet been reached for IGR and we propose to use a range of 6-6.4% for 
recruitment into this study in both India and the UK to ensure that only patients at high risk 
are recruited. Baseline HbA1c has been found to be a better predictor of incident diabetes 
than the glucose values in the Indian population. 
Specific objectives of the project are: 
• To assess the efficacy in terms of progression to diabetes, and user acceptability, of a 
mobile phone-based lifestyle modification programme for people at risk of type 2 diabetes, 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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evaluating acceptable frequency and user selected content of the intervention in India and 
the UK 
• to assess the effectiveness of such a lifestyle modification programme on change in 
objectively measured physical activity levels and on other CVD risk factors 
• to assess the cost-effectiveness of this mobile phone-based lifestyle modification 
programme on the progression to diabetes and on improvement of the physical activity level 
over a 2 year period 
• to develop and evaluate a pragmatic and scalable approach to identifying people at high 
risk of developing type 2 diabetes based on HbA1c in India. 
Diabetes is projected to cause an estimated 4 million deaths globally in people aged 
between 20-79 years in 2010, which is equal to 6.8% of all expected deaths10. The potential 
for lifestyle interventions to reduce the progression to diabetes from high risk states has 
been demonstrated in a number of RCTs in different countries, with a meta-analysis of RCTs 
suggesting that lifestyle intervention in high risk subjects can halve the incidence11. The 
lifestyle modification RCTs showing reduced progression to diabetes in high risk subjects 
have given impressive results. They have however been expensive and labour intensive, 
with multiple personal contacts (including in some instances home visits) for those in the trial 
that were deemed to be failing to achieve their goals. Such intensive input is not practical on 
a large scale. Alternative methods to induce behavioural change, including contact via 
mobile phones or home computer, have been employed with success in other clinical 
situations. 
A randomized controlled trial assessed ‘Sweet Talk’, a text messaging system designed to 
support young people with diabetes12. Subjects aged between 8y and 18y were randomized 
to conventional therapy, conventional therapy and ‘Sweet Talk’ or intensive insulin therapy 
with ‘Sweet Talk’. Conventional goal setting was reinforced by daily text messages 
containing personalized prompts and tailored messages. HbA1c only improved in subjects 
randomized to intensive therapy and ‘Sweet Talk’. However ‘Sweet Talk’ was associated 
with improvements in diabetes self-management and self reported adherence; 82% of 
subjects felt that ‘Sweet Talk’ had improved their diabetes self- management and 90% 
wanted to continue to receive messages. In a recent meta- analysis of text messaging in the 
management of established diabetes (both type 1 and type 2), 22 trials covering 1657 
participants were selected for review13. Although criticisms could be made about publication 
bias, results from pooled data suggested that significant improvements in glycaemia and 
self-management were possible using mobile phone intervention. 
Similar degrees of success and acceptability have been observed in other trials of the 
effectiveness of mobile telephone text messaging, for example as a reminder tool for 
improving adherence to sunscreen application14 and in a weight management programme in 
African American women15. The proof of principle for lifestyle modification using text 
messaging interventions in other clinical situations has therefore been established. 
In the UK, recruitment of high risk subjects will be from GP databases following HbA1c 
measurement as part of the NHS Health Checks and from routine screening of at-risk adults. 
NHS Health Checks, a cardiovascular risk assessment programme for all adults aged 40-74 
years in England, was introduced in 2009 at an annual cost of £250 million. This 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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government-funded population-based programme aims to both accelerate overall reductions 
in CVD and diabetes incidence, and reduce known socio-economic and ethnic inequalities in 
cardiovascular health and diabetes. Delivered in primary care, the programme involves the 
systematic measurement of CVD risk factors and we shall select practices (the majority) in 
which HbA1c has been chosen as the indicator of glucose homeostasis.  
The UK limb will be centred on a multi-ethnic population in London. There are 42,000 people 
eligible for the NHS Health Checks in this area. Between 8,000 and 14,000 people will be 
identified with IGR during the five year roll out of the National screening programme, that is 
between 1,600 and 2,800 people with IGR identified per year. Neighbouring areas in London 
will also participate as required. 
Potential risks and benefits The potential risks and burdens for research participants are 
as follows: 
 
At screening, visits 3,4 and 5 there is a venous blood test. These have the potential to cause 
discomfort. This will be minimised by experienced research personnel and appropriate use 
of equipment. The text messaging intervention may be irritating to subjects though the 
evidence base suggests that health interventions delivered in this way are welcomed. 
Subjects will be able to choose which day and which time of day they receive their 
messages to improve acceptability and minimise disruption. 
 
The study requires minimal visits and only the randomisation and 6 month visits are over and 
above usual care for people at high risk of developing diabetes. All visits will be arranged 
according to subject preference for time and location. 
 
The delivery of an education package for IGR at the start of the study for all participants is 
an advantage and is additional care above that usually delivered for people diagnosed with 
IGR. 
 
The trial will be conducted in compliance with the protocol, GCP and the applicable 
regulatory requirement(s). 
 
Population to be studied Subjects with impaired glucose regulation aged 18-74 
 
Trial Objectives and Purpose This study assesses the efficacy, acceptability and cost-
effectiveness of a text messaging system for delivering lifestyle advice to people with 
impaired glucose regulation. 
 
Trial Design Subjects with impaired glucose regulation (defined as an HbA1c of 6.0-6.4%) 
will be randomised to usual care or usual care with text messaging. Text messages will be 
delivered three times weekly and will contain educational, motivational and supportive 
content on diet, physical activity, lifestyle and smoking. The content will be appropriate to the 
stage of the transtheoretical model of behavioural change that the subject is in (see 
appendices for transtheoretical model questionnaire, assessment scale and text messages). 
The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or 
over. Secondary outcomes are: 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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• 
Change in physical activity as measured by Actigraph and Recent Physical Activity 
Questionnaire (RPAQ) 
• 
Change in weight, BMI, waist circumference, hip circumference and waist:hip ratio 
• 
Change in fasting plasma glucose and HbA1c 
• 
Change in lipid profile (total cholesterol, triglycerides, LDL cholesterol and HDL 
cholesterol) 
• 
Liver function as measured by alanine transaminase (ALT), aspartate transaminase 
(AST) and gamma-glutamyl transferase (GGT) 
• 
Change in diet assessed by validated food frequency questionnaire 
• 
Quality of life assessed by EQ-5D questionnaire 
• 
Acceptability of text message intervention assessed by questionnaire 
• 
Cardiovascular biomarkers including hsCRP, adiponectin, PAI (plasminogen activator 
inhibitor), uric acid, white cell count, albumin, IL-6, IL-1, TNF-α, monocytes 
chemotactic protein-1, leptin, resistin, endothelin-1, E-selectin, soluble vascular 
cellular adhesion molecule-1 (sVCAM-1) and soluble interstitial cellular adhesion 
molecule-1 (sICAM-1) 
• 
Insulin secretion and sensitivity 
Lifestyle modification targets in the study are in line with previously published type 2 
diabetes prevention studies: 
1. A minimum of 150 minutes moderate intensity exercise per week 
2. A minimum of 7% weight loss or achievement of a BMI of 25kg/m2 (23kg/m2 in South 
Asian subjects) 
3. Less than 30% of total Kcal intake from fat 
4. Less than 10% of total Kcal intake from saturated fat 
5. Greater than 15g fibre per 1000Kcal intake 
 
Methodology Randomised, controlled trial. 
 
Timescale It is anticipated that the study will take 3 years with each subject being enrolled 
for 2 years with a total of 5 visits in that period. 
 
Population n=2268 across the UK and India. n=1134 in UK sites randomized equally to 2 
groups of 567. 
 
Recruitment will be undertaken in both primary and secondary care targeting people with 
impaired glucose regulation (IGR). Identifying this group of people will be done by searching 
existing pathology databases held in NHS laboratories or GP records for fasting plasma 
glucose, HbA1c or an oral glucose tolerance test. These glycaemic measurements are done 
as part of the NHS Health check programme or other routine screening and are performed in 
NHS hospital labs. Access to the record of laboratory results will be done by only authorised 
personnel in the pathology department. Potential participants meeting the inclusion criteria 
for the study will be sent letters of invitation by the study team. Existing samples will not be 
used in the study. In addition, adverts and face to face talks to potential participants can be 
used where appropriate. An invitation letter and a participant information sheet together with 
a reply slip will be sent to potential participants.  Those who have shown interest in the reply 
slips are encouraged to ask questions about the study. Only those who have agreed to take 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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part will be invited for screening.  Informed consent will be taken before conducting any 
study procedures. During screening, glycaemic status will be confirmed with an HbA1c.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
No concomitant medical therapies are contra-indicated. All study visits will take place in a 
local clinic at one of NHS research collaborating sites for the study. 
 
Visit 1: Screening 
• 
Attend fasting 
• 
Routine clinical examination including measurement of height, weight, waist 
circumference, hip circumference 
• 
Measurement of blood pressure and heart rate 
• 
15mL (approximately 3 tablespoons) of venous blood taken for glucose, HbA1c, 
lipids, Creatinine, ALT, AST, GGT, insulin, cardiovascular biomarkers and serum 
save 
• 
Urine pregnancy test in female subjects of childbearing age 
• 
Random urine sample for microalbumin:creatinine ratio 
• 
EQ-5D, RPAQ, TTM and food frequency questionnaires completed 
• 
Actigraph physical activity monitor fitted according to manufacturer’s instructions and 
worn for 7 days. Pre-paid addressed envelopes will be provided for the return of the 
Actigraph device or subjects may return them to the clinic. 
 
Visit 2: Education and Randomisation 
• 
Delivery of structured education for IGR including: 
o Define IGR 
o Implications of IGR in progression to diabetes 
o Prevention of type 2 diabetes 
o Healthy lifestyle advice 
o Dietary advice 
o Physical activity advice 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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o Written material given (see appendix) 
• 
Randomised to control (usual care) or text message arm with randomisation 
minimised by gender and age in decades. 
 
Visit 3: 6 Month Follow-up 
• 
Attend fasting 
• 
Routine clinical examination including measurement of height, weight, waist 
circumference, hip circumference 
• 
Measurement of blood pressure and heart rate 
• 
15mL (approximately 3 tablespoons) of venous blood taken for glucose, HbA1c, 
lipids, Creatinine, ALT, AST, GGT, insulin, cardiovascular biomarkers and serum 
save 
• 
Urine pregnancy test in female subjects of childbearing age 
• 
Random urine sample for microalbumin:creatinine ratio 
• 
EQ-5D, RPAQ, TTM, food frequency and acceptability questionnaires completed 
• 
Actigraph physical activity monitor fitted according to manufacturer’s instructions and 
worn for 7 days. Pre-paid addressed envelopes will be provided for the return of the 
Actigraph device or subjects may return them to the clinic. 
 
Visit 4: 12 Month Follow-up 
• 
Attend fasting 
• 
Routine clinical examination including measurement of height, weight, waist 
circumference, hip circumference 
• 
Measurement of blood pressure and heart rate 
• 
15mL (approximately 3 tablespoons) of venous blood taken for glucose, HbA1c, 
lipids, Creatinine, ALT, AST, GGT, insulin, cardiovascular biomarkers and serum 
save 
• 
Urine pregnancy test in female subjects of childbearing age 
• 
Random urine sample for microalbumin:creatinine ratio 
• 
EQ-5D, RPAQ, TTM, food frequency and acceptability questionnaires completed 
Actigraph physical activity monitor fitted according to manufacturer’s instructions and 
worn for 7 days. Pre-paid addressed envelopes will be provided for the return of the 
Actigraph device or subjects may return them to the clinic. 
 
Visit 5: 24 Month Follow-up 
• 
Attend fasting 
• 
Routine clinical examination including measurement of height, weight, waist 
circumference, hip circumference 
• 
Measurement of blood pressure and heart rate 
• 
15mL (approximately 3 tablespoons) of venous blood taken for glucose, HbA1c, 
lipids, Creatinine, ALT, AST, GGT, insulin, cardiovascular biomarkers and serum 
save 
• 
Urine pregnancy test in female subjects of childbearing age 
• 
Random urine sample for microalbumin:creatinine ratio 
• 
EQ-5D, RPAQ, TTM, food frequency and acceptability questionnaires completed 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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• 
Actigraph physical activity monitor fitted according to manufacturer’s instructions and 
worn for 7 days. Pre-paid addressed envelopes will be provided for the return of the 
Actigraph device or subjects may return them to the clinic. 
 
Data During the course of the study visits some data will be stored on laptop computers, not 
connected to the internet, for later statistical analysis. These data will be coded and non 
identifiable. Participant data will be stored in a locked filing cabinet in a secure room in 
Imperial College Healthcare NHS Trust. Only the research team (clinical research fellow and 
research nurse) will have access to the filing cabinet. Electronic data will be stored by 
subject number only on NHS desktop computers which are in the same locked room. At the 
end of each visit the anonymised data will be transferred immediately to the secure NHS 
computers and will be deleted from the laptop. Access to NHS computers is only by 
members of NHS staff with appropriate login privileges. 
All data will be stored in an anonymised form by using study numbers for identification of 
participants. The NHS code of confidentiality will be followed and all activity will meet the 
requirements of the data protection act. 
Only members of the clinical research team and those responsible for direct care will have 
access to subjects' data during the study. The data generated by the study will be analysed 
by the research team from Imperial College. The analysis will be on anonymised data and 
will take place in Imperial College Healthcare NHS Trust and in Imperial College academic 
buildings in the Faculty of Medicine. 
 
Subject inclusion criteria Subjects may be recruited if: 
Adults 18 yrs or over and less than 75 yrs  
HbA1c between 6.0-6.4% (42-47 mmol/mol)  
(HbA1c test performed within a week before full screening date can be used for inclusion 
criteria.) 
 
Subject exclusion criteria Subjects are excluded if: 
FPG equal or greater than 7.0 mmol/l 
Pregnant or planning pregnancy 
Breastfeeding 
Enrolled in other clinical trials 
Have active malignancy or under investigation for malignancy 
Are unable to follow the protocol for any other reason 
 
Subject withdrawal criteria Subjects will be withdrawn from the study in the case of: 
1. Loss of capacity to give informed consent 
2. Terminal illness 
3. Diagnosis of type 2 diabetes by any validated criteria in any care setting (see 
Efficacy for more details) 
Withdrawal will be immediate and subjects will be followed up in the appropriate care setting. 
 
Efficacy  
The primary outcome will be progression to type 2 diabetes as measured by FPG (Fasting 
Plasma Glucose) or HbA1c at visits 3, 4 and 5 or by any validated criteria in any other care 
setting. The WHO/IDF criteria for diagnosis of diabetes will be used throughout. 
 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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1. If participant presents symptoms of diabetes and, FPG (Fasting Plasma Glucose) 
≥ 7.0 OR HbA1c ≥ 48 then no repeat test is needed.  The participant is diabetic. 
2. If the participant does not present symptoms of diabetes; 
• 
If FPG ≥ 7.0 and HbA1c ≥ 48 then repeat both tests after 4 weeks.  If the 
repeat results are FPG ≥ 7.0 or / and HbA1c ≥ 48, the participant is diabetic. 
• 
If FPG < 7.0 and HbA1c ≥ 48 then repeat HbA1c after 4 weeks.  If the second 
result is ≥ 48, the participant is diabetic. 
• 
If FPG ≥ 7.0 and HbA1c < 48 then repeat FPG after 4 weeks.  If the second 
result is ≥ 7.0, the participant is diabetes. 
 
Secondary outcomes will be: 
• 
Change in physical activity as measured by Actigraph and Recent Physical Activity 
Questionnaire (RPAQ) 
• 
Change in weight, BMI, waist circumference, hip circumference and waist:hip ratio 
• 
Change in fasting plasma glucose and HbA1c 
• 
Change in lipid profile 
• 
Liver function as measured by alanine transaminase (ALT), aspartate transaminase 
(AST) and gamma-glutamyl transferase (GGT) 
• 
Change in diet assessed by validated food frequency questionnaire 
• 
Quality of life assessed by EQ-5D questionnaire 
• 
Cardiovascular biomarkers including hsCRP, adiponectin, PAI (plasminogen activator 
inhibitor), uric acid, white cell count, albumin, IL-6, IL-1, TNF-α, monocytes 
chemotactic protein-1, leptin, resistin, endothelin-1, E-selectin, soluble vascular 
cellular adhesion molecule-1 (sVCAM-1) and soluble interstitial cellular adhesion 
molecule-1 (sICAM-1) 
• 
Insulin secretion and sensitivity as calculated from fasting plasma glucose and insulin 
measurements 
 
Safety Adverse events will be reported to the REC, the sponsor and the Principal 
Investigator immediately. Subjects will be followed-up after one week following an adverse 
event and thereafter in the clinically indicated follow up setting. 
 
Statistics Missing, unused, and spurious data will be assessed on an individual basis and 
may be ignored, withdrawn or the visit may be removed from the analysis with appropriate 
justification adjudicated by the Principal Investigator. 
 
Direct Access to Source Data/Documents The investigator(s)/institution(s) will permit trial-
related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct 
access to source data/documents. 
 
Regulatory Issues 
  
Ethics Approval The Chief Investigator has obtained approval from the Westminster 
Research Ethics Committee.  The study must be submitted for Site Specific Assessment 
(SSA) at each participating NHS Trust.  The Chief Investigator will require a copy of the 
Trust R&D approval letter before accepting participants into the study.  The study will be 
conducted in accordance with the recommendations for physicians involved in research on 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later 
revisions. 
  
Consent Consent to enter the study must be sought from each participant only after a full 
explanation has been given, an information leaflet offered and time allowed for 
consideration.  Signed participant consent should be obtained.  The right of the participant to 
refuse to participate without giving reasons must be respected.  After the participant has 
entered the study the clinician remains free to give alternative treatment to that specified in 
the protocol at any stage if he/she feels it is in the participant’s best interest, but the reasons 
for doing so should be recorded.  In these cases the participants remain within the study for 
the purposes of follow-up and data analysis.  All participants are free to withdraw at any time 
from the protocol treatment without giving reasons and without prejudicing further treatment. 
  
Confidentiality The Chief Investigator will preserve the confidentiality of participants taking 
part in the study and is registered under the Data Protection Act. 
  
Indemnity Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study. 
 
Sponsor Imperial College Academic Health Science Centre will act as the main Sponsor for 
this study.  Delegated responsibilities will be assigned to the NHS trusts taking part in this 
study.  
  
Funding The Medical Research Council of the UK is funding this study. 
  
Audits The study may be subject to inspection and audit by Imperial College London under 
their remit as sponsor and other regulatory bodies to ensure adherence to GCP and the 
NHS Research Governance Framework for Health and Social Care (2nd edition). 
   
Study Management The day-to-day management of the study will be co-ordinated by 
Professor D Johnston. Weekly research meetings and monthly data reviews will be chaired 
by the chief investigator or other senior researcher. Annual reports to the funder and sponsor 
will be written and submitted. A data monitoring committee will be convened including a lay 
member with diabetes and appropriate experts not involved with the study. 
  
Publication Policy The study will be registered on the clinicaltrials.gov system and results 
will be disseminated by peer reviewed scientific journals, internal report, conference 
presentation and publication on websites. No identifiable personal data will be published. All 
anthropometry and personal clinical data will be expressed as mean/ median and spread of 
the population in the study. All participants will be informed of the results by letter at the 
conclusion of the study and details of any publications that arise from the study will be 
disseminated to participants.   
 
 
 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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References 
 
1. Ramachandran A, Ma RC ,Snehalatha C. Diabetes in Asia. Lancet.2010;375:408-18. 
2. Decode Study Group. Age and Sex Specific Prevalence of Diabetes and Impaired 
Glucose Tolerance in 13 European Countries. Diabetes Care 2003;26:61-69 
3. deVegt F, Dekker JM, Jager A, et al:Relation of impaired fasting and post load 
glucose with incident type 2 diabetes in a Dutch population. JAMA 2001;285:2109–
2113. 
4. Alberti KGMM. The clinical implications of impaired glucose tolerance. Diabet Med 
1996; 13:927-937. 
5. Ramachandran A, Snehalatha Cet al. The Indian Diabetes Prevention Programme 
shows that lifestyle modification and metformin prevent type 2 diabetes in Asian 
Indian subjects with impaired glucose tolerance (IDPP-1) Diabetologia 2006;49:289–
297 
6. TuomilehtoJ, Lindström J, Eriksson JG, et al: Prevention of type 2 diabetes mellitus  
by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J 
Med 2001;344:1343-1350 
7. PanXR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in 
people with IGT. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537-
544 
8. Diabetes Prevention Program Research Group. Reduction in the Incidence of Type 2 
Diabetes with Lifestyle Intervention or Metformin. NEJM 2002;346:393-403. 
9. The international expert committee. International expert committee report on the role 
of the A1c assay in the diagnosis of diabetes. Diabetes Care 2009; 32:1-8. 
10. World 
Health 
Organisation. 
Diabetes 
[Internet]. 
2009 
;Available 
from: 
www.who.int/mediacentre/factsheets/fs312/en/index.html 
11. Gillies C, Abrams K, Lambert P, Cooper N, Sutton A, Hsu R, et al. Pharmacological 
and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired 
glucose tolerance: systematic review and meta-analysis. BMJ. 2007 334:299. 
12. Franklin V. L, Waller A, Palgient C, Green SA .A randomized controlled trial of Sweet 
Talk, A text messaging stem to support young p eople with diabetes. Diabetic 
Medicine 2006;12:1332-1338 
13. X. Liang, et al. Effect of mobile phone intervention for diabetes on glycaemic control: 
a meta-analysis. Diabet. Med. 2011; 28: 455–463. 
14. Armstrong AW et al. Text Message reminders to improve sunscreen use: a 
randomized controlled trial using electronic monitoring. Archives of Dermatology 
2009;145:1319- 1321 
15. Gerber BS et al. Mobile Phones text messaging to promote healthy Behaviours and 
weight Loss Maintenance: a feasibility study. Health Informatics 2009;15:17-25 
 
 

 
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Supplements 
 
i. REC form 
ii. RPAQ 
iii. Food frequency questionnaire 
iv. EQ-5D 
v. TTM Questionnaire 
vi. TTM Scoring sheet 
vii. Written education material 
viii. Text message list 
 
 
  
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
4 
Visit 
5 
Clinical Examination 
✓ 
 
✓ 
✓ 
✓ 
Vital signs 
✓ 
 
✓ 
✓ 
✓ 
Blood test 
✓ 
 
✓ 
✓ 
✓ 
Urine test 
✓ 
 
✓ 
✓ 
✓ 
Pregnancy test 
✓ 
 
✓ 
✓ 
✓ 
RPAQ 
✓ 
 
✓ 
✓ 
✓ 
FFQ 
✓ 
 
✓ 
✓ 
✓ 
EQ-5D 
✓ 
 
✓ 
✓ 
✓ 
Acceptability questionnaire 
 
 
✓ 
✓ 
✓ 
TTM questionnaire 
✓ 
 
✓ 
✓ 
✓ 
Randomisation 
 
✓ 
 
 
 
Education 
 
✓ 
 
 
 
 
 
 
 
 
 
RPAQ= Recent physical activity questionnaire 
 
 
 
 
FFQ = Food frequency questionnaire 
 
 
 
TTM = Transtheoretical model 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 

 
Diabetes Prevention Using SMS Protocol v1.9 (17/06/2015) 
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•Examination
•Vital signs
•Blood test
•Urine tests
•Questionnaires
•Actigraph
Visit 1: Screening
•Structured IGR education
•Randomisation to usual care or text messaging service
Visit 2: Education 
and 
Randomisation
•Examination
•Vital signs
•Blood test
•Urine tests
•Questionnaires
•Actigraph
Visit 3: 6 Month 
Follow-up
•Examination
•Vital signs
•Blood test
•Urine tests
•Questionnaires
•Actigraph
Visit 4: 12 Month 
Follow-up
•Examination
•Vital signs
•Blood test
•Urine tests
•Questionnaires
•Actigraph
Visit 5: 24 Month 
Follow-up