Top

Published in:

Open Access 01-12-2021 | Hyperglycemia | Research article

Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial

Authors: Kamlesh Khunti, Simon Griffin, Alan Brennan, Helen Dallosso, Melanie J. Davies, Helen C. Eborall, Charlotte L. Edwardson, Laura J. Gray, Wendy Hardeman, Laura Heathcote, Joe Henson, Daniel Pollard, Stephen J. Sharp, Stephen Sutton, Jacqui Troughton, Tom Yates

Published in: BMC Medicine | Issue 1/2021

Abstract

Background

Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention.

Methods

Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013–2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables.

Results

One thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up.

Conclusions

Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months.

Trial registration

ISRCTN 83465245 (registered on 14 June 2012).

Available only for authorised users

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. https://doi.org/10.1136/bmj.39063.689375.55.CrossRefPubMedPubMedCentral

Dunkley AJ, 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(4):922–33. https://doi.org/10.2337/dc13-2195.CrossRefPubMed

Ali MK, Bullard KM, Imperatore G, Benoit SR, Rolka DB, Albright AL, et al. Reach and use of diabetes prevention services in the United States, 2016-2017. JAMA Netw Open. 2019;2(5):e193160. https://doi.org/10.1001/jamanetworkopen.2019.3160.CrossRefPubMedPubMedCentral

Valabhji J, Barron E, Bradley D, Bakhai C, Fagg J, O’Neill S, et al. Early Outcomes From the English National Health Service Diabetes Prevention Programme. Diabetes Care. 2020;43(1):152–60. https://doi.org/10.2337/dc19-1425.CrossRefPubMed

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(6):1116–26. https://doi.org/10.1007/s00125-007-0638-8.CrossRefPubMedPubMedCentral

McCarthy M, Edwardson CL, Davies MJ, Henson J, Gray L, Khunti K, et al. Change in Sedentary Time, Physical Activity, Bodyweight, and Hba1c in High-Risk Adults. Med Sci Sports Exerc. 2017;49(6):1120–5. https://doi.org/10.1249/MSS.0000000000001218.CrossRefPubMedPubMedCentral

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. https://doi.org/10.1016/S0140-6736(13)62061-9.CrossRefPubMed

Yates T, Edwardson CL, Henson J, Gray LJ, Ashra NB, Troughton J, et al. Walking Away from Type 2 diabetes: a cluster randomized controlled trial. Diab Med. 2017;34(5):698–707. https://doi.org/10.1111/dme.13254.CrossRef

Yates T, Griffin S, Bodicoat DH, Brierly G, Dallosso H, Davies MJ, et al. 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. Trials. 2015;16(1):289. https://doi.org/10.1186/s13063-015-0813-z.CrossRefPubMedPubMedCentral

10.

National Institute for Health and Clinical Excellence. Preventing type 2 diabetes: risk identification and interventions for individuals at high risk. 2012; Available at: https://www.nice.org.uk/guidance/ph 38. Accessed 02/08, 2016.

11.

Morton KL, Sutton SR, Hardeman W, Troughton J, Yates T, Griffin SJ, et al. A text-messaging and pedometer program to promote physical activity in people at high risk of type 2 diabetes: A development and feasibility study for the PROPELS Trial. JMIR mHealth and uHealth. 2015;3(4):e105

12.

Lee JA, Williams SM, Brown DD, Laurson KR. Concurrent validation of the Actigraph gt3x , Polar Active accelerometer, Omron HJ-720 and Yamax Digiwalker SW-701 pedometer step counts in lab-based and free-living settings. J Sports Sci. 2015;33(10):991–1000. https://doi.org/10.1080/02640414.2014.981848.CrossRefPubMed

13.

Abel MG, Peritore N, Shapiro R, Mullineaux DR, Rodriguez K, Hannon JC. A comprehensive evaluation of motion sensor step-counting error. Appl Physiol Nutr Metab. 2011;36(1):166–70. https://doi.org/10.1139/H10-095.CrossRefPubMed

14.

Tudor-Locke C, Johnson WD, Katzmarzyk PT. Accelerometer-determined steps per day in US adults. Med Sci Sports Exerc. 2009;41(7):1384–91. https://doi.org/10.1249/MSS.0b013e318199885c.CrossRefPubMed

15.

Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998;30(5):777–81. https://doi.org/10.1097/00005768-199805000-00021.CrossRefPubMed

16.

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. 2009;91(1):106–14. https://doi.org/10.3945/ajcn.2009.28432.CrossRefPubMed

17.

Panter J, Jones A, van Sluijs E, Griffin S, Wareham N. Environmental and psychological correlates of older adult’s active commuting. Med Sci Sports Exerc 2011;43(7):1–17.

18.

NAVIGATOR Study G, McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, et al. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010;362(16):1477–90.CrossRef

19.

White IR, Carpenter J, Horton NJ. Including all individuals is not enough: Lessons for intention-to-treat analysis. Clin Trials. 2012;9(4):396–407. https://doi.org/10.1177/1740774512450098.CrossRefPubMedPubMedCentral

20.

Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of depression and anxiety on change to physical activity following a pragmatic diabetes prevention program within primary care: Pooled analysis from two randomized controlled trials. Diabetes Care. 2019;42(10):1847–53. https://doi.org/10.2337/dc19-0400.CrossRefPubMed

21.

Chudasama YV, Khunti KK, Zaccardi F, Rowlands AV, Yates T, Gillies CL, et al. Physical activity, multimorbidity, and life expectancy: a UK Biobank longitudinal study. BMC Med. 2019;17(1):108. https://doi.org/10.1186/s12916-019-1339-0.CrossRefPubMedPubMedCentral

22.

Rowlands A, Davies M, Dempsey P, Edwardson C, Razieh C, Yates T. Wrist-worn accelerometers: recommending~ 1.0 mg as the minimum clinically important difference (MCID) in daily average acceleration for inactive adults. Br J Sports Med. 2020. https://doi.org/10.1136/bjsports-2020-102293.

23.

Balducci S, D'Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, et al. Effect of a Behavioral Intervention Strategy on Sustained Change in Physical Activity and Sedentary Behavior in Patients With Type 2 Diabetes: The IDES_2 Randomized Clinical Trial. JAMA. 2019;321(9):880–90. https://doi.org/10.1001/jama.2019.0922.CrossRefPubMed

24.

Harris T, Kerry SM, Limb ES, Furness C, Wahlich C, Victor CR, et al. Physical activity levels in adults and older adults 3–4 years after pedometer-based walking interventions: Long-term follow-up of participants from two randomised controlled trials in UK primary care. Plos Med. 2018;15(3):1–16.

25.

Unick JL, Gaussoin SA, Hill JO, Jakicic JM, Bond DS, Hellgren M, et al. Four-Year Physical Activity Levels among Intervention Participants with Type 2 Diabetes. Med Sci Sports Exerc. 2016;48(12):2437–45. https://doi.org/10.1249/MSS.0000000000001054.CrossRefPubMedPubMedCentral

26.

M Marmot M. Fair society, healthy lives: the Marmot review; strategic review of health inequalities in England post-2010. The Marmot Review, Institute for Health Equity, 2010. Available at: http://www.instituteofhealthequity.org/resources-reports/fair-society-healthy-lives-the-marmot-review (10 March 2021, date last accessed)

27.

Smith M, Hosking J, Woodward A, Witten K, MacMillan A, Field A, et al. Systematic literature review of built environment effects on physical activity and active transport–an update and new findings on health equity. Int J Beha Nutr Phys Activity. 2017;14(1):1–27.CrossRef

28.

Singh N, Stewart RAH, Benatar JR. Intensity and duration of lifestyle interventions for long-term weight loss and association with mortality: a meta-analysis of randomised trials. BMJ Open. 2019;9:e029966.CrossRef

29.

Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006;29(9):2102–7. https://doi.org/10.2337/dc06-0560.CrossRefPubMedPubMedCentral

30.

Baumann S, Groß S, Voigt L, Ullrich A, Weymar F, Schwaneberg T, et al. Pitfalls in accelerometer-based measurement of physical activity: The presence of reactivity in an adult population. Scand J Med Sci Sports. 2018;28(3):1056–63. https://doi.org/10.1111/sms.12977.CrossRefPubMed

31.

Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community: the DEPLOY pilot study. Am J Prev Med. 2008;35(4):357–63. https://doi.org/10.1016/j.amepre.2008.06.035.CrossRefPubMedPubMedCentral

32.

Absetz P, Valve R, Oldenburg B, Heinonen H, Nissinen A, Fogelholm M, et al. Type 2 diabetes prevention in the “real world”: one-year results of the GOAL Implementation Trial. Diabetes Care. 2007;30(10):2465–70. https://doi.org/10.2337/dc07-0171.CrossRefPubMed

33.

Henson J, Dunstan DW, Davies MJ, Yates T. Sedentary behaviour as a new behavioural target in the prevention and treatment of type 2 diabetes. Diab Metab Res Rev. 2016;32:213–20. https://doi.org/10.1002/dmrr.2759.CrossRef

Title: Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial
Authors: Kamlesh Khunti
Simon Griffin
Alan Brennan
Helen Dallosso
Melanie J. Davies
Helen C. Eborall
Charlotte L. Edwardson
Laura J. Gray
Wendy Hardeman
Laura Heathcote
Joe Henson
Daniel Pollard
Stephen J. Sharp
Stephen Sutton
Jacqui Troughton
Tom Yates
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Hyperglycemia
Diabetes Prevention
Published in: BMC Medicine / Issue 1/2021
Electronic ISSN: 1741-7015
DOI: https://doi.org/10.1186/s12916-021-01997-4

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial

Abstract

Background

Methods

Results

Conclusions

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Estimating the health and economic effects of the voluntary sodium reduction targets in Brazil: microsimulation analysis

Choice of HbA1c threshold for identifying individuals at high risk of type 2 diabetes and implications for diabetes prevention programmes: a cohort study

The risk of ischemic stroke and hemorrhagic stroke in Chinese adults with low-density lipoprotein cholesterol concentrations < 70 mg/dL

Meat consumption and risk of 25 common conditions: outcome-wide analyses in 475,000 men and women in the UK Biobank study

Correction to: Following the science? Comparison of methodological and reporting quality of covid-19 and other research from the first wave of the pandemic

Research priorities for Long Covid: refined through an international multi-stakeholder forum