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.

Autor/Urheber	Thomson, Hazel; Oliver, Nick; Godsland, Ian F; Darzi, Ara; Srivanichakorn, Weerachai; Majeed, Azeem; Johnston, Desmond G; Nanditha, Arun; Snehalatha, Chamukuttan; Raghavan, Arun; Susairaj, Priscilla; Simon, Mary; Satheesh, Krishnamoorthy; Ramachandran, Am
Institution	BioMed Central; BMC endocrine disorders
Titel	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.
Quelle	In: doi:10.17863/CAM.32759(2018) PDF als Volltext kostenfreie Datei
Sprache	englisch
Dokumenttyp	online; Zeitschriftenaufsatz
DOI	10.17863/CAM.32759
Schlagwörter	Humans; Diabetes Mellitus; Type 2; Blood Glucose; Exercise; Follow-Up Studies; Motivation; Adolescent; Adult; Aged; Middle Aged; India; Female; Male; Young Adult; Text Messaging; United Kingdom
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. ; Funding was obtained jointly from the Indian Council for Medical Research and the UK Medical Research Council (Joint funding ref.: MR/J000183/1).
Erfasst von	BASE - Bielefeld Academic Search Engine