Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol
- C K Chow1,2,3,
- J Redfern1,2,
- A Thiagalingam3,
- S Jan1,2,
- R Whittaker4,
- M Hackett1,2,
- N Graves5,
- J Mooney1,
- G S Hillis1,6
- 1The George Institute for Global Health, Sydney, Australia
- 2University of Sydney, Sydney, Australia
- 3Westmead Hospital, Sydney, Australia
- 4University of Auckland, Auckland, New Zealand
- 5Queensland University of Technology, Queensland, Australia
- 6Concord Hospital, Sydney, Australia
- Correspondence to Dr Julie Redfern;
- Received 11 November 2011
- Accepted 19 December 2011
- Published 19 January 2012
Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease, providing access to such interventions is a major challenge. This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk.
Methods and analysis Randomised controlled trial with 6 months of follow-up to evaluate the feasibility, acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care. A total of 720 patients with coronary artery disease will be randomised to either standard care or the TEXT ME intervention. The intervention group will receive multiple weekly text messages that provide information, motivation, support to quit smoking (if relevant) and recommendations for healthy diets and exercise. The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months. Secondary end points include a change in systolic blood pressure, smoking status, quality of life, medication adherence, waist circumference, physical activity levels, nutritional status and mood at 6 months. Process outcomes related to acceptability and feasibility of TEXT ME will also be collected.
Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee—Westmead. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences.
Clinical trials registration number ACTRN12611000161921.
To cite: Chow CK, Redfern J, Thiagalingam A, et al. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open 2012;2:e000606. doi:10.1136/bmjopen-2011-000606
Funding This work is supported by a National Heart Foundation of Australia Grant-in-Aid (G10S5110) and a BUPA Foundation Grant. CKC is funded by a Sidney Sax Public Health Fellowship co-funded by the National Health and Medical Research Council (NHMRC) and National Heart Foundation (512119) and Sydney Medical Foundation Chapman Fellowship. JR is funded by a Postdoctoral Fellowship co-funded by the NHMRC and National Heart Foundation (632933). MH is in receipt of an NHMRC Career Development Award (632925). SJ is funded by an NHMRC Career Development Award (457117). GSH is funded by a New South Wales Office for Science and Medical Research, Life Sciences Research Award. The organisations that supported this work (through peer-reviewed educational research grants) had no role in study conception, data collection, analysis and interpretation and writing of the manuscript. All authors had full access to the data. All authors had the final responsibility for the decision to submit for publication.
Competing interests None.
Ethics approval The study was approved by Western Sydney Local Health Network Human Research Ethics Committee (Westmead).
Contributors CKC, JR, AT and GSH conceived the original concept of the study. All authors contributed to the design of the study, are involved in the implementation of the project and have read and approved the final manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.
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