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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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: Tom Yates, Simon Griffin, Danielle H Bodicoat, Gwen Brierly, Helen Dallosso, Melanie J Davies, Helen Eborall, Charlotte Edwardson, Mike Gillett, Laura Gray, Wendy Hardeman, Sian Hill, Katie Morton, Stephen Sutton, Jacqui Troughton, Kamlesh Khunti

Published in: Trials | Issue 1/2015

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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
Literature
1.
World Health Organization. Mortality and Burden of Disease Attributable to Selected Major Risk Factors. Geneva, Switzerland: World Health Organization; 2009.
2.
3.
4.
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.CrossRefPubMed
5.
Department of Health and Public Health England. NHS Health Check Programme Best Practice Guidance. UK: DOH and Public Health England; 2013.
6.
National Institute of Health and Clinical Excellence. Preventing type 2 diabetes: risk identification and interventions for individuals at high risk. London: NICE; 2012.
7.
World Health Organisation Diabetes Development Committee. Definition and diagnoses of diabetes mellitus and intermediate hyperglycaemia. Geneva, Switzerland: World Health Organization; 2006.
8.
International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009;32(7):1327–34.CrossRef
9.
10.
Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, et al. Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ. 2007;334(7588):299.CrossRefPubMedPubMedCentral
11.
Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Pratley R, et al. Impaired fasting glucose and impaired glucose tolerance: implications for care. Diabetes Care. 2007;30(3):753.CrossRefPubMed
12.
Bassuk SS, Manson JE. Epidemiological evidence for the role of physical activity in reducing risk of type 2 diabetes and cardiovascular disease. J Appl Physiol. 2005;99(3):1193–204.CrossRefPubMed
13.
Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, et al. Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. Lancet. 2014;383(9922):1059–66.CrossRefPubMed
14.
Laaksonen DE, Lindström J, Lakka TA, Eriksson JG, Niskanen L, Wikström K, et al. Physical activity in the prevention of type 2 diabetes the Finnish Diabetes Prevention Study. Diabetes. 2005;54(1):158–65.CrossRefPubMed
15.
Yates T, Khunti K, Bull F, Gorely T, Davies MJ. The role of physical activity in the management of impaired glucose tolerance: A systematic review. Diabetologia. 2007;50:1116–26.CrossRefPubMedPubMedCentral
16.
Kinmonth AL, Wareham NJ, Hardeman W, Sutton S, Prevost AT, Fanshawe T, et al. Efficacy of a theory-based behavioural intervention to increase physical activity in an at-risk group in primary care (ProActive UK): a randomised trial. Lancet. 2008;371(9606):41–8.CrossRefPubMed
17.
Yates T, Davies M, Khunti K. Preventing type 2 diabetes: can we make the evidence work? Postgrad Med J. 2009;85(1007):475–80.CrossRefPubMed
18.
Johnson M, Jones R, Freeman C, Woods HB, Gillett M, Goyder E, et al. Can diabetes prevention programmes be translated effectively into real-world settings and still deliver improved outcomes? A synthesis of evidence. Diabet Med. 2013;30(1):3–15.CrossRefPubMed
19.
Dunkley A, Bodicoat DH, Greaves CJ, Russell C, Yates T, Davies MJ, et al. Diabetes Prevention in the Real World: Effectiveness of Pragmatic Lifestyle Interventions for the Prevention of Type 2 Diabetes and of the Impact of Adherence to Guideline Recommendations. A Systematic Review and Meta-analysis. Diabetes Care. 2014;37:922–33.CrossRefPubMed
20.
Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, et al. Let's Prevent Diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012;11:56.CrossRefPubMedPubMedCentral
21.
Naughton F, Jamison J, Boase S, Sloan M, Gilbert H, Prevost AT, et al. Randomized controlled trial to assess the short‐term effectiveness of tailored web‐and text‐based facilitation of smoking cessation in primary care (iQuit in Practice). Addiction. 2014;109(7):1184–93.CrossRefPubMedPubMedCentral
22.
Lin PH, Wang Y, Levine E, Askew S, Lin S, Chang C, et al. A text messaging‐assisted randomized lifestyle weight loss clinical trial among overweight adults in Beijing. Obesity. 2014;22(5):E29–37.CrossRefPubMed
23.
Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, et al. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013;1(3):191–8.CrossRefPubMed
24.
Thompson S, Sallis JF, Calfas K, Patrick K. Text4Diet: a randomized controlled study using text messaging for weight loss behaviors. Prev Med. 2012;55(5):412–7.CrossRefPubMed
25.
Wald DS, Bestwick JP, Raiman L, Brendell R, Wald NJ. Randomised Trial of Text Messaging on Adherence to Cardiovascular Preventive Treatment (INTERACT Trial). PLoS One. 2014;9(12):e114268.CrossRefPubMedPubMedCentral
26.
Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev 2012: 12. 2012.
27.
Barnett AH, Dixon AN, Bellary S, Hanif MW, O'hare JP, Raymond NT, et al. Type 2 diabetes and cardiovascular risk in the UK south Asian community. Diabetologia. 2006;49:2234–46.CrossRefPubMed
28.
Fischbacher CM, Hunt S, Alexander L. How physically active are South Asians in the United Kingdom? A literature review. J Public Health. 2004;26:250–8.CrossRef
29.
Yates T, Davies MJ, Gray LJ, Webb D, Henson J, Gill JM, et al. Levels of physical activity and relationship with markers of diabetes and cardiovascular disease risk in 5474 white European and South Asian adults screened for type 2 diabetes. Prev Med. 2010;51:290–4.CrossRefPubMed
30.
Ghouri N, Purves D, McConnachie A, Wilson J, Gill JMR, Sattar N. Lower cardiorespiratory fitness contributes to increased insulin resistance and fasting glycaemia in middle-aged South Asian compared with European men living in the UK. Diabetologia. 2013;56(10):2238–49.CrossRefPubMedPubMedCentral
31.
Williams ED, Stamatakis E, Chandola T, Hamer M. Physical activity behaviour and coronary heart disease mortality among South Asian people in the UK: an observational longitudinal study. Heart. 2011;97:655–9.CrossRefPubMed
32.
Yates T, Davies M, Gorely T, Bull F, Khunti K. Effectiveness of a pragmatic education programme aimed at promoting walking activity in individuals with impaired glucose tolerance: a randomized controlled trial. Diabetes Care. 2009;32(8):1404–10.CrossRefPubMedPubMedCentral
33.
National Institute for Health and Clinical Excellence. Guidance on the use of Patient Education Models for Diabetes (Technology Appraisal 60). London: NICE; 2003.
34.
Davies M, Heller S, Skinner T, Campbell M, Carey M, Cradock S, et al. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. Br Med J. 2008;336(7642):491–5.CrossRef
35.
Gillett M, Dallosso HM, Dixon S, Brennan A, Carey ME, Campbell MJ, et al. Delivering the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cost effectiveness analysis. BMJ. 2010;341:c4093.CrossRefPubMedPubMedCentral
36.
Paulweber B, Valensi P, Lindstrom J, Lalic NM, Greaves CJ, McKee M, et al. A European evidence-based guideline for the prevention of type 2 diabetes. Horm Metab Res. 2010;42 Suppl 1:S3–36.CrossRefPubMed
37.
Yates T, Davies M, Sehmi S, Gorely T, Khunti K. The Prediabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: Are improvements in glucose regulation sustained at two years? Diabet Med. 2011;28(10):1268–71.CrossRefPubMed
38.
Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:979–83.CrossRef
39.
Gray LJ, Davies MJ, Hiles S, Taub NA, Webb DR, Srinivasan BT, et al. Detection of impaired glucose regulation and/or type 2 diabetes mellitus, using primary care electronic data, in a multiethnic UK community setting. Diabetologia. 2012;55(4):959–66.CrossRefPubMed
40.
World Health Organisation. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. Geneva, Switzerland: World Health Organization 2011.
41.
Leventhal H, Meyer D, Nerenz D. The common-sense representation of illness danger. Contributions to Medical Psychology. 2nd ed. New York: Pergamon; 1980. p. 7–30.
42.
Yates T, Davies M, Gorley T, Bull F, Khunti K. Rationale, design and baseline data from the PREPARE (Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement) programme study: a randomized controlled trial. Patient Educ Couns. 2008;73:264–71.CrossRefPubMed
43.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95.CrossRefPubMed
44.
Skinner T, Carey M, Cradock S, Dallosso H, Daly H, Davies M, et al. ‘Educator talk’ and patient change: some insights from the DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) randomized controlled trial. Diabet Med. 2008;25(9):1117–20.CrossRefPubMed
45.
Tudor-Locke C, Johnson WD, Katzmarzyk PT. Accelerometer-determined steps per day in US adults. Med Sci Sports Exerc. 2009;41(7):1384–91.CrossRefPubMed
46.
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998;30(5):777–81.CrossRefPubMed
47.
Besson H, Brage S, Jakes RW, Ekelund U, Wareham NJ. Estimating physical activity energy expenditure, sedentary time, and physical activity intensity by self-report in adults. Am J Clin Nutr. 2010;91:106–14.CrossRefPubMed
48.
Panter JR, Jones AP, van Sluijs EM, Griffin SJ. Attitudes, social support and environmental perceptions as predictors of active commuting behaviour in school children. J Epidemiol Community Health. 2010;64(1):41–8.CrossRefPubMedPubMedCentral
49.
Panter JR, Jones AP, van Sluijs EM, Griffin SJ, Wareham NJ. Environmental and psychological correlates of older adults's active commuting. Med Sci Sports Exerc. 2011;43(7):1235–43.CrossRefPubMed
50.
Bingham SA, Gill C, Welch AA, Cassidy A, Runswick SA, Oakes S, et al. Validation of dietary assessment methods in the UK arm of EPIC using weighed records, and 24-hour urinary nitrogen and potassium and serum vitamin C and carotenoids as biomarkers. Int J Epidemiol. 1997;26 Suppl 1:S137.CrossRefPubMed
51.
McMurray JJ, Holman RR, Rutten GE, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010;362(16):1477–90.CrossRefPubMed
52.
Ganswisch JE, Heymsfield SB, Boden-Albala B, Buijs RM, Kreier F, Pickering TG, et al. Sleep duration as a risk factor for Diabetes incidence in a larger US sample. Sleep. 2007;30(12):1667–73.
53.
Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ. 1998;316:736–41.CrossRefPubMedPubMedCentral
54.
Ware JE, Kosinski M, Dewey JE, Gandek B. How to score and interpret single-item health status measures: a manual for users of the SF-8 Health Survey. Lincoln: Quality Metric Incorporated; 2001.
55.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 2006;67:361–70.CrossRef
56.
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60:631–7.CrossRefPubMed
57.
Tudor-Locke C, Bassett DR. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34:1–8.CrossRefPubMed
58.
Chan C, Ryan D, Tudor-Locke C. Health benefits of a pedometer-based physical activity intervention in sedentary workers. Prev Med. 2004;39(6):1215–22.CrossRefPubMed
59.
Merom D, Rissel C, Phongsavan P, Smith B, Van Kemenade C, Brown W, et al. Promoting walking with pedometers in the community: the step-by-step trial. Am J Prev Med. 2007;32(4):290–7.CrossRefPubMed
60.
Health Survey for England: Physical activity and fitness. NHS Information Centre for health and social care, London; 2009.
61.
Santaguida PL, Balion C, Hunt D, Morrison K, Gerstein H, Raina P, et al. Diagnosis, prognosis and treatment of impaired glucose tolerance and impaired fasting glucose. Rockville (MD): Agency for Healthcare Research and Quality; 2005.
62.
Curtis L. Unit Costs of Health and Social Care 2012. Personal Social Services Research Unit (PSSRU): University of Kent; 2012.
63.
Lindström J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, et al. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003;26(12):3230–6.CrossRefPubMed
64.
Gillett M, Chilcott J, Goyder E, Payne N, Thokala P, Freeman C, et al. Prevention of Type 2 Diabetes: Risk Identification and Interventions for Individuals at High Risk – Economic Review and Modelling. ScHARR Public Health Collaborating Centre, University of Sheffield; 2012.
65.
Stevens RJKV, Adler AI, Stratton IM. United Kingdom Prospective Diabetes Study (UKPDS) Group. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Sci (Lond). 2001;101(6):671–9.CrossRef
66.
Kothari V, Stevens RJ, Adler AI, Stratton IM, Manley SE, Neil HA, et al. UKPDS 60: Risk of Stroke in Type 2 Diabetes Estimated by the UK Prospective Diabetes Study Risk Engine. Stroke. 2002;33(7):1776–81.CrossRefPubMed
67.
Leventhal H, Meyer D, Nerenz D. The common-sense representation of illness danger. Contributions to medical psychology. 1980:pp7-30.
68.
Bandura A: Social foundations of thought and action: A social cognitive theory. New Jersey: Prentice-Hall Inc; 1986.
69.
Chaiken S. The heuristic model of persuasion. In: Zanna MP, Olson JM, Herman CP, editors. Social influence: The Ontario symposium. 5th ed. Hillsdale, NJ: Erlbaum; 1987. p. 3–39.
70.
Gollwitzer P. Implementation Intentions: Strong Effects of simple plans: How can good intentions become effective behaviour change strategies. Am Psychol. 1999;54:493–503.CrossRef
Metadata
Title
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
Tom Yates
Simon Griffin
Danielle H Bodicoat
Gwen Brierly
Helen Dallosso
Melanie J Davies
Helen Eborall
Charlotte Edwardson
Mike Gillett
Laura Gray
Wendy Hardeman
Sian Hill
Katie Morton
Stephen Sutton
Jacqui Troughton
Kamlesh Khunti
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0813-z

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