Randomized Controlled Trial

. 2015 Jul 2:16:289.

doi: 10.1186/s13063-015-0813-z.

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

Tom Yates^{1

2

3}, Simon Griffin⁴, Danielle H Bodicoat^{5

6}, Gwen Brierly⁷, Helen Dallosso⁸, Melanie J Davies^{9

10

11}, Helen Eborall¹², Charlotte Edwardson^{13

14}, Mike Gillett¹⁵, Laura Gray^{16

17}, Wendy Hardeman¹⁸, Sian Hill¹⁹, Katie Morton²⁰, Stephen Sutton²¹, Jacqui Troughton²², Kamlesh Khunti^{23

24}

Affiliations

¹ NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. ty20@le.ac.uk.
² Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ty20@le.ac.uk.
³ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ty20@le.ac.uk.
⁴ Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Forvie Site, Box 113 Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. sjg49@medschl.cam.uk.
⁵ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.
⁶ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.
⁷ MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. gwen.brierly@mrc-epid.cam.uk.
⁸ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Helen.dallosso@uhl-tr.nhs.uk.
⁹ NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. melanie.davies@uhl-tr.nhs.uk.
¹⁰ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.
¹¹ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.
¹² Social Science Applied to Healthcare Improvement Research (SAPPHIRE) Group, Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. hce3@le.ac.uk.
¹³ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ce95@le.ac.uk.
¹⁴ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ce95@le.ac.uk.
¹⁵ School of Health & Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. m.gillett@sheffield.ac.uk.
¹⁶ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. lg48@le.ac.uk.
¹⁷ Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. lg48@le.ac.uk.
¹⁸ Behavioural Science Group, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge, School of Clinical Medicine Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. wh207@medschl.cam.ac.uk.
¹⁹ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. sian.hill@uhl-tr.nhs.uk.
²⁰ UK CRC Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. km576@medschl.cam.ac.uk.
²¹ Behavioural Science Group, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge, School of Clinical Medicine Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. srs34@medschl.cam.ac.uk.
²² Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Jacqui.troughton@uhl-tr.nhs.uk.
²³ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. kk22@le.ac.uk.
²⁴ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. kk22@le.ac.uk.

PMID: 26130075
PMCID: PMC4488033
DOI: 10.1186/s13063-015-0813-z

Randomized Controlled Trial

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

Tom Yates et al. Trials. 2015.

. 2015 Jul 2:16:289.

doi: 10.1186/s13063-015-0813-z.

Authors

Affiliations

¹ NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. ty20@le.ac.uk.
² Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ty20@le.ac.uk.
³ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ty20@le.ac.uk.
⁴ Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Forvie Site, Box 113 Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. sjg49@medschl.cam.uk.
⁵ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.
⁶ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.
⁷ MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. gwen.brierly@mrc-epid.cam.uk.
⁸ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Helen.dallosso@uhl-tr.nhs.uk.
⁹ NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. melanie.davies@uhl-tr.nhs.uk.
¹⁰ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.
¹¹ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.
¹² Social Science Applied to Healthcare Improvement Research (SAPPHIRE) Group, Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. hce3@le.ac.uk.
¹³ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ce95@le.ac.uk.
¹⁴ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ce95@le.ac.uk.
¹⁵ School of Health & Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. m.gillett@sheffield.ac.uk.
¹⁶ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. lg48@le.ac.uk.
¹⁷ Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. lg48@le.ac.uk.
¹⁸ Behavioural Science Group, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge, School of Clinical Medicine Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. wh207@medschl.cam.ac.uk.
¹⁹ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. sian.hill@uhl-tr.nhs.uk.
²⁰ UK CRC Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. km576@medschl.cam.ac.uk.
²¹ Behavioural Science Group, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge, School of Clinical Medicine Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. srs34@medschl.cam.ac.uk.
²² Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Jacqui.troughton@uhl-tr.nhs.uk.
²³ Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. kk22@le.ac.uk.
²⁴ Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. kk22@le.ac.uk.

PMID: 26130075
PMCID: PMC4488033
DOI: 10.1186/s13063-015-0813-z

Abstract

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. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.

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.

PubMed Disclaimer

Figures

**Fig. 1**
Flow of participants through the study

See this image and copyright information in PMC

References

1. World Health Organization . Mortality and Burden of Disease Attributable to Selected Major Risk Factors. Geneva, Switzerland: World Health Organization; 2009.
1. International Diabetes Federation. IDF Diabetes Atlas. http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0.pdf: IDF; 2013.
1. Leung M, Pollack L, Colditz G, Chang S. Life Years Lost and Lifetime Healthcare Expenditures Associated With Diabetes in the U.S., National Health Interview Survey, 1997–2000. Diabetes Care. 2014; http://care.diabetesjournals.org/content/early/2014/12/18/dc14-1453.full.... - PMC - PubMed
1. Hex N, Bartlett C, Wright D, Taylor M, Varley D. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med. 2012;29(7):855–62. doi: 10.1111/j.1464-5491.2012.03698.x. - DOI - PubMed
1. Department of Health and Public Health England . NHS Health Check Programme Best Practice Guidance. UK: DOH and Public Health England; 2013.

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ISRCTN Controlled Trials

Grants and funding

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- MedlinePlus Consumer Health Information
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical