Yates 2015 PROPELS Protocol.pdf (626.46 kB)
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PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): Study protocol for a randomized controlled trial

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journal contribution
posted on 10.08.2015, 09:00 by Tom Yates, S. Griffin, Danielle H. Bodicoat, G. Brierly, Helen Dallosso, Melanie J. Davies, Helen Eborall, Charlotte Edwardson, M. Gillett, Laura Gray, W. Hardeman, Sian Hill, K. Morton, S. Sutton, Jacqui Troughton, Kamlesh Khunti
Background: The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. Methods/Design: A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4 % (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Discussion: This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. Trial registration: ISRCTN83465245. Trial registration date: 14/06/2012

History

Citation

Trials 2015, 16, 289

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciences

Version

VoR (Version of Record)

Published in

Trials 2015

Publisher

BioMed Central Ltd

eissn

1745-6215

Acceptance date

18/06/2015

Copyright date

2015

Available date

10/08/2015

Publisher version

http://www.trialsjournal.com/content/16/1/289

Language

en