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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

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Title: 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
Authors: Thomson, HH
Srivanichakorn, W
Oliver, N
Godsland, I
Darzi, A
Majeed, A
Johnston, D
Item Type: Journal Article
Abstract: Background Type 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. However, implementing lifestyle modification programmes to high risk groups is expensive and alternative cheaper methods are needed. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. The aim of the study is to assess the efficacy and user acceptability of text messaging employed in this way for people with pre-diabetes (HbA1c 6.0% to ≤6.4%; 42–47 mmol/mol) in the UK and India. Methods/design This is a randomised, controlled trial with participants followed up for 2 years. After being screened and receiving a structured education programme for prediabetes, participants are randomised to a control or intervention group. In the intervention group, text messages are delivered 2–3 times weekly and contain educational, motivational and supportive content on diet, physical activity, lifestyle and smoking. The control group undergoes monitoring only. In India, the trial involves 5 visits after screening (0, 6, 12, 18 and 24 months). In the UK there are 4 visits after screening (0, 6, 12 and 24 months). Questionnaires (EQ-5D, RPAQ, Transtheoretical Model of Behavioural Change, and food frequency (UK)/24 h dietary recall (India)) and physical activity monitors (Actigraph GT3X+ accelerometers) are assessed at baseline and all follow-up visits. The SMS acceptability questionnaires are evaluated in all follow-up visits. The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or over(India) and by any WHO criterion(UK). Secondary outcomes are the changes in body weight, body mass index, waist circumference, blood pressure, fasting plasma glucose; lipids; proportion of participants achieving HbA1c ≤6.0%; HOMA-IR; HOMA-β; acceptability of SMS; dietary parameters; physical activity and quality of life. Discussion The study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries
Issue Date: 10-Sep-2018
Date of Acceptance: 31-Aug-2018
URI: http://hdl.handle.net/10044/1/63990
DOI: https://dx.doi.org/10.1186/s12902-018-0293-8
ISSN: 1472-6823
Publisher: BioMed Central
Journal / Book Title: BMC Endocrine Disorders
Volume: 18
Copyright Statement: © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: MR/J000183/1
Keywords: Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
Short messaging service
Prediabetes
HbA1c
Diabetes prevention
Randomised controlled trial
IMPAIRED GLUCOSE-TOLERANCE
METAANALYSIS
POPULATION
VALIDATION
DIAGNOSIS
METFORMIN
EQ-5D-3L
RECALLS
PROGRAM
SAMPLE
1103 Clinical Sciences
Publication Status: Published
Article Number: ARTN 63
Online Publication Date: 2018-08-31
Appears in Collections:Division of Surgery
Department of Medicine
Faculty of Medicine
Epidemiology, Public Health and Primary Care



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