Diabetes Prevention Using SMS Technology
A Pragmatic and Scaleable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
2 other identifiers
interventional
2,062
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2013
CompletedFirst Posted
Study publicly available on registry
February 21, 2013
CompletedStudy Start
First participant enrolled
June 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedResults Posted
Study results publicly available
November 12, 2019
CompletedOctober 30, 2020
October 1, 2020
4.5 years
February 19, 2013
October 22, 2019
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Progression to Type 2 Diabetes
The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.
24 months
Secondary Outcomes (6)
Body Weight
Baseline and 24 months
Blood Pressure
Baseline and 24 months
HDL Cholesterol
Baseline and 24 months
LDL Cholesterol
Baseline and 24 months
Triglycerides
Baseline and 24 months
- +1 more secondary outcomes
Study Arms (2)
Text Messages
EXPERIMENTALShort text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.
Control
NO INTERVENTIONHalf of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults 18 yrs or over and less than 75 yrs
- HbA1c between 6.0-6.4%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Barts & The London NHS Trustcollaborator
- Mid and South Essex NHS Foundation Trustcollaborator
- Lister Hospitalcollaborator
- Torbay Hospitalcollaborator
- Queen Alexandra Hospitalcollaborator
- East Surrey Hospitalcollaborator
- Pennine Acute Hospitals NHS Trustcollaborator
- West Suffolk Hospitalcollaborator
- Derriford Hospitalcollaborator
- Exeter Hospitalcollaborator
- Milton Keynes University Hospital NHS Foundation Trustcollaborator
- Royal Cornwall Hospitals Trustcollaborator
- Queen Margaret Hospital, Dunfermlinecollaborator
- Harrogate & District NHS Foundation Trustcollaborator
- Royal Berkshire NHS Foundation Trustcollaborator
- Rotherham NHS Trustcollaborator
Study Sites (1)
Imperial college Healthcare NHS Trust
London, W2 1NY, United Kingdom
Related Publications (2)
Nanditha A, Thomson H, Susairaj P, Srivanichakorn W, Oliver N, Godsland IF, Majeed A, Darzi A, Satheesh K, Simon M, Raghavan A, Vinitha R, Snehalatha C, Westgate K, Brage S, Sharp SJ, Wareham NJ, Johnston DG, Ramachandran A. A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial. Diabetologia. 2020 Mar;63(3):486-496. doi: 10.1007/s00125-019-05061-y. Epub 2020 Jan 9.
PMID: 31919539DERIVEDThomson H, Oliver N, Godsland IF, Darzi A, Srivanichakorn W, Majeed A, Johnston DG, Nanditha A, Snehalatha C, Raghavan A, Susairaj P, Simon M, Satheesh K, Ramachandran A, Sharp S, Westgate K, Brage S, Wareham N. Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK. BMC Endocr Disord. 2018 Sep 10;18(1):63. doi: 10.1186/s12902-018-0293-8.
PMID: 30200935DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nick Oliver
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Desmond G Johnston, PhD, MB ChB
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2013
First Posted
February 21, 2013
Study Start
June 3, 2013
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
October 30, 2020
Results First Posted
November 12, 2019
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share