Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial

Laura Staun Valentiner, Mathias Ried-Larsen, Kristian Karstoft, Cecilie Fau Brinkløv, Charlotte Brøns, Rasmus Oestergaard Nielsen, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg, Laura Staun Valentiner, Mathias Ried-Larsen, Kristian Karstoft, Cecilie Fau Brinkløv, Charlotte Brøns, Rasmus Oestergaard Nielsen, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg

Abstract

Introduction: Physical activity is a cornerstone in type 2 diabetes (T2D) rehabilitation. Effective long-term and low-cost strategies to keep these patients' physically active are needed. However, maintaining physical activity behaviour is difficult once formalised interventions end. Structured exercise training supported by mobile technology and remote feedback is potentially an effective strategy. The objective of the trial is to investigate whether mobile health support using the InterWalk application for smartphones is effective in increasing physical activity levels in persons with T2D over time compared with standard care. We investigate whether Interval Walking Training using the InterWalk application is superior to Danish municipality-based rehabilitation in increasing moderate-and-vigorous physical activity levels in patients with T2D across 52 weeks. Secondary, we hypothesise that a motivational programme added from end of intervention to 52 weeks further increases level of physical activity in everyday life in patients with T2D.

Methods and analysis: The trial is a parallel-group, open-labelled, randomised controlled trial with long-term follow-up at 52 week including patients with T2D. The primary outcome is change in moderate-and-vigorous physical activity. The key secondary outcome includes motivation for physical activity behaviour change. Other secondary outcomes are VO2-peak, strength in the lower extremities. Exclusion criterion is medical contraindication to exercise. We include up to 246 patients and randomly allocate them into a control (standard group) or an experimental group (8-12 weeks of IWT supported by the smartphone-based InterWalk application) in a 1:2 fashion. After intervention, the experimental group is randomly allocated into two follow-up conditions with unsupervised IWT with or without motivational support until 52-week follow-up. The intention-to-treat principle is applied.

Ethics and dissemination: The local regional Research Ethics Committee in Denmark (H-1-2014-074) and the Danish Data Protection Agency (j.nr. 2014-54-0897) have approved the trial. Positive, negative or inconclusive results will be disseminated in scientific journals and conferences.

Trial registration number: NCT02341690.

Keywords: Behaviour maintenance; Interval Walking Training; Physical Activity; Rehabilitation; Type 2 diabetes.

Conflict of interest statement

Competing interests: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Timeline and overview of interventions in the InterWalk trial. Phase I shows baseline-test, randomisation, intervention and test after intervention. Phase II shows the reallocation of patients in the experimental group who do Interval Walking Training (IWT with the InterWalk app to either IWT with or without motivational support form a health professional). All patients are tested at baseline, after intervention and again at follow-up at 52 weeks.
Figure 2
Figure 2
Flow chart, The InterWalk-RCT Trial. RCT, randomised controlled trial.
Figure 3
Figure 3
The InterWalk front page (A), protocol for the fitness test in the application (B), the start page for interval walking showing smileys as direct feedback to the user (C) (translated from Danish).
Figure 4
Figure 4
Short message service (SMS), send every Sunday to patients in the IWTsupport-group. IWT, Interval Walking Training.
Figure 5
Figure 5
Short message service (SMS), Standardised walking test in the InterWalk application, send every fourth week to patients in the IWTsupport-group. IWT, Interval Walking Training.

References

    1. Colberg SR, Sigal RJ, Fernhall B, et al. . Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care 2010;33:2692–6. 10.2337/dc10-1548
    1. Plotnikoff RC, Costigan SA, Karunamuni ND, et al. . Community-based physical activity interventions for treatment of type 2 diabetes: a systematic review with meta-analysis. Front Endocrinol (Lausanne) 2013;4:3 10.3389/fendo.2013.00003
    1. Umpierre D, Kramer CK, Leita CB, et al. . Clinician's Corner physical activity advice only or structured with HbA 1c levels in type 2 diabetes. JAMA 2013;305:190–9.
    1. Nicolucci A, Balducci S, Cardelli P, et al. . Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES). Diabetologia 2012;55:579–88. 10.1007/s00125-011-2425-9
    1. Vadstrup ES, Frølich A, Perrild H, et al. . Health-related quality of life and self-related health in patients with type 2 diabetes: effects of group-based rehabilitation versus individual counselling. Health Qual Life Outcomes 2011;9:110 10.1186/1477-7525-9-110
    1. Avery L, Flynn D, Van Wersch A, et al. . Changing physical activity behavior in type 2 diabetes: a systematic review and meta-analysis of behavioral interventions. Diabetes Care 2012;35:2681–9. 10.2337/dc11-2452
    1. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010;87:4–14. 10.1016/j.diabres.2009.10.007
    1. Whiting DR, Guariguata L, Weil C, et al. . IDF Diabetes Atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract 2011;94:311–21. 10.1016/j.diabres.2011.10.029
    1. Cochrane Collaboration. Special Collection: health of Indigenous peoples: diabetes 2015.
    1. Policy EHealth, . .
    1. Di Loreto C, Fanelli C, Lucidi P, et al. . Make your diabetic patients walk: long-term impact of different amounts of physical activity on type 2 diabetes. Diabetes Care 2005;28:1295–302. 10.2337/diacare.28.6.1295
    1. Eakin EG, Reeves MM, Lawler SP, et al. . The Logan Healthy Living Program: a cluster randomized trial of a telephone-delivered physical activity and dietary behavior intervention for primary care patients with type 2 diabetes or hypertension from a socially disadvantaged community—rationale, design and recruitment. Contemp Clin Trials 2008;29:439–54. 10.1016/j.cct.2007.10.005
    1. Tatara N, Årsand E, Bratteteig T, et al. . Usage and perceptions of a mobile self-management application for people with type 2 diabetes: qualitative study of a five-month trial. Stud Health Technol Inform 2013;192:127–31. 10.3233/978-1-61499-289-9-127
    1. Karstoft K, Winding K, Knudsen SH, et al. . The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care 2013;36:228–36. 10.2337/dc12-0658
    1. Ried-larsen M, Thomsen RW, Berencsi K, et al. . Implementation of interval walking training in patients with type 2 diabetes in Denmark: rationale, design, and baseline characteristics. Clincal Epidemiol 2016;8:201–9. 10.2147/CLEP.S97303
    1. Saida T, Langberg H. Self-Reported adherence to physical activity following physical activity referral scheme & objective measured physical activity in self-referred subgroup: a pragmatic 12 month follow-up study. 2017. (in press).
    1. Ogden J, Hills L. Understanding sustained behavior change: the role of life crises and the process of reinvention. Health (London) 2008;12:419–37. 10.1177/1363459308094417
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 10.1136/bmj.e7586
    1. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726–32. 10.7326/0003-4819-152-11-201006010-00232
    1. Thomsen RW, Nielsen JS, Ulrichsen SP, et al. . The Danish Centre for Strategic research in type 2 diabetes (DD2) study: collection of baseline data from the first 580 patients. Clin Epidemiol 2012;4:43–8. 10.2147/CLEP.S30083
    1. Thygesen LC, Daasnes C, Thaulow I, et al. . Introduction to Danish (nationwide) registers on health and social issues: structure, access, legislation, and archiving. Scand J Public Health 2011;39:12–16. 10.1177/1403494811399956
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patient with chronic illness: the chonic care model, Part 2. JAMA 2002;288:1909–14. 10.1001/jama.288.15.1909
    1. Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports 2006;16(Suppl 1):3–63. 10.1111/j.1600-0838.2006.00520.x
    1. Brinkløv CF, Thorsen IK, Karstoft K, et al. . Criterion validity and reliability of a smartphone delivered sub-maximal fitness test for people with type 2 diabetes. BMC Sports Sci Med Rehabil 2016;8:31 10.1186/s13102-016-0056-7
    1. Locke EA. Toward a theory of task motivation and incentives. Organ Behav Hum Perform 1968;3:157–89. 10.1016/0030-5073(68)90004-4
    1. Miller WR, Rollnick S. Motivational interviewing: preparing people for change. 2nd edn New York, NY: Guilford Press, 2002.
    1. Chen SM, Creedy D, Lin HS, et al. . Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial. Int J Nurs Stud 2012;49:637–44. 10.1016/j.ijnurstu.2011.11.011
    1. Locke EA, Latham GP. New directions in goal-setting theory. SAGE 2006;15:265–8.
    1. Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med 2009;36:165–73. 10.1016/j.amepre.2008.09.040
    1. Ryan RM, Deci EL. Intrinsic and extrinsic motivations: classic definitions and new directions. Contemp Educ Psychol 2000;25:54–67. 10.1006/ceps.1999.1020
    1. Shaya TF, Chirikov VV, Howard D, et al. . Effect of social networks intervention in type 2 diabetes: a partial randomised study. J Epidemiol Community Heal 2014;68:326–32. 10.1136/jech-2013-203274
    1. Paul G, Keogh K, D'Eath M, et al. . Implementing a peer-support intervention for people with type 2 diabetes: a qualitative study. Fam Pract 2013;30:593–603. 10.1093/fampra/cmt027
    1. Drivsholm TB, Snorgaard O. Organisation of treatment and follow up of patients with type 2 diabetes. J Danish Med Assoc 2012;174:2159–62.
    1. Snowling NJ, Hopkins WG. Effects of different modes of exercise training on glucose control and risk factors for complications in type 2 diabetic patients: a meta-analysis. Diabetes Care 2006;29:2518–27. 10.2337/dc06-1317
    1. Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr 2013;97:505–16. 10.3945/ajcn.112.042457
    1. Evert AB, Boucher JL, Cypress M, et al. . Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care 2013;36:3821–42. 10.2337/dc13-2042
    1. Palmer SC, Mavridis D, Nicolucci A, et al. . Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA 2016;316:313–24. 10.1001/jama.2016.9400
    1. Ware J Jr, Kosinski M, Keller S. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33. 10.1097/00005650-199603000-00003
    1. Gardner B. A review and analysis of the use of “habit” in understanding, predicting and influencing health-related behaviour. Health Psychol Rev 2015;9:277–95. 10.1080/17437199.2013.876238
    1. Gardner B, Abraham C, Lally P, et al. . Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act 2012;9:102 10.1186/1479-5868-9-102
    1. Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport 1999;70:113–19. 10.1080/02701367.1999.10608028
    1. Golubic R, May AM, Benjaminsen Borch K, et al. . Validity of electronically administered recent physical activity questionnaire (RPAQ) in ten European countries. PLoS One 2014;9:e92829 10.1371/journal.pone.0092829
    1. Mortensen EL, Flensborg-Madsen T, Molbo D, et al. . Personality in late midlife: associations with demographic factors and cognitive ability. J Aging Health 2014;26:21–36. 10.1177/0898264313519317
    1. Zuckerman M, Kolin EA, Price L, et al. . Development of a sensation-seeking scale. 1964;28:477–82.
    1. Kirk A, Mutrie N, MacIntyre P, et al. . Effects of a 12-month physical activity counselling intervention on glycaemic control and on the status of cardiovascular risk factors in people with type 2 diabetes. Diabetologia 2004;47:821–32. 10.1007/s00125-004-1396-5
    1. De Greef K, Deforche B, Tudor-Locke C, et al. . A cognitive-behavioural pedometer-based group intervention on physical activity and sedentary behaviour in individuals with type 2 diabetes. Health Educ Res 2010;25:724–36. 10.1093/her/cyq017
    1. Savović J, Jones HE, Altman DG, et al. . Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157:429–38. 10.7326/0003-4819-157-6-201209180-00537
    1. Wood L, Egger M, Gluud LL, et al. . Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. Bmj 2008;336:601–5. 10.1136/
    1. Gluud LL. Bias in clinical intervention research. Am J Epidemiol 2006;163:493–501. 10.1093/aje/kwj069
    1. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310;2191–94.

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