The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial

Ida Kær Thorsen, Yanxiang Yang, Laura Staun Valentiner, Charlotte Glümer, Kristian Karstoft, Jan Christian Brønd, Rasmus Oestergaard Nielsen, Charlotte Brøns, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg, Mathias Ried-Larsen, Ida Kær Thorsen, Yanxiang Yang, Laura Staun Valentiner, Charlotte Glümer, Kristian Karstoft, Jan Christian Brønd, Rasmus Oestergaard Nielsen, Charlotte Brøns, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg, Mathias Ried-Larsen

Abstract

Background: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required.

Objective: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D.

Methods: The study was designed as a parallel-group, randomized trial with 52 weeks' intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight, and waist circumference.

Results: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] -0.8 [-8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of -2.3 (95% CI -4.1 to -0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes.

Conclusions: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL.

Trial registration: ClinicalTrials.gov NCT02341690; https://ichgcp.net/clinical-trials-registry/NCT02341690.

Keywords: accelerometry; exercise; mHealth; mobile app; primary health care; quality of life; telemedicine; type 2 diabetes mellitus; waist circumference.

Conflict of interest statement

Conflicts of Interest: None declared.

©Ida Kær Thorsen, Yanxiang Yang, Laura Staun Valentiner, Charlotte Glümer, Kristian Karstoft, Jan Christian Brønd, Rasmus Oestergaard Nielsen, Charlotte Brøns, Robin Christensen, Jens Steen Nielsen, Allan Arthur Vaag, Bente Klarlund Pedersen, Henning Langberg, Mathias Ried-Larsen. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 28.09.2022.

Figures

Figure 1
Figure 1
Participant flowchart.
Figure 2
Figure 2
Least squares means (95% CI’s) of MVPA time (min/day) at baseline, 12-week and 52-week follow-up for the IWT and StC group. IWT: interval walking training; MVPA: moderate-and-vigorous physical activity; StC: standard care.
Figure 3
Figure 3
Forest plot of overall and subgroup effects of IWT vs. StC on change in MVPA time (min/day) after 52 weeks. Subgroup effects include sex (men/women), type 2 diabetes duration (≤5 years/>5 years), alcohol consumption (within the recommended levels/above recommendations), smoking habits (smoker/nonsmoker), highest level of education (ISCED-2011 levels 0-4/ISCED-2011 levels 5-8), civil status (single, divorced or widowed/married or cohabiting), SF-12 PCS (high/low), and SF-12 MCS (high/low), assessed at baseline. ISCED: International Standard Classification of Education; IWT: interval walking training; MCS: Mental Component Summary; PCS: Physical Component Summary; SF-12: 12-item Short-Form Health Survey; StC: standard care; T2D: type 2 diabetes.

References

    1. American Diabetes Association 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Diabetes Care. 2020 Jan;43(Suppl 1):S48–S65. doi: 10.2337/dc20-S005.43/Supplement_1/S48
    1. Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 01;54(2):353–368. doi: 10.1249/MSS.0000000000002800.00005768-202202000-00018
    1. Balducci S, Sacchetti M, Haxhi J, Orlando G, D'Errico V, Fallucca S, Menini S, Pugliese G. Physical exercise as therapy for type 2 diabetes mellitus. Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:13–23. doi: 10.1002/dmrr.2514.
    1. Booth FW, Hawley JA. The erosion of physical activity in Western societies: an economic death march. Diabetologia. 2015 Aug;58(8):1730–4. doi: 10.1007/s00125-015-3617-5.
    1. Beedie C, Mann S, Jimenez A, Kennedy L, Lane AM, Domone S, Wilson S, Whyte G. Death by effectiveness: exercise as medicine caught in the efficacy trap! Br J Sports Med. 2016 Mar;50(6):323–4. doi: 10.1136/bjsports-2014-094389. bjsports-2014-094389
    1. Church TS, Blair SN. When will we treat physical activity as a legitimate medical therapy...even though it does not come in a pill? Br J Sports Med. 2009 Feb;43(2):80–1. doi: 10.1136/bjsm.2008.053850.bjsm.2008.053850
    1. Ried-Larsen M, MacDonald CS, Johansen MY, Hansen KB, Christensen R, Almdal TP, Pedersen BK, Karstoft K. Why prescribe exercise as therapy in type 2 diabetes? We have a pill for that! Diabetes Metab Res Rev. 2018 Jul;34(5):e2999. doi: 10.1002/dmrr.2999.
    1. Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard A, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637–646. doi: 10.1001/jama.2017.10169. 2648632
    1. Look AHEAD Research Group. Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten Brent, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374–83. doi: 10.2337/dc07-0048. dc07-0048
    1. Church TS, Blair SN, Cocreham S, Johannsen N, Johnson W, Kramer K, Mikus CR, Myers V, Nauta M, Rodarte RQ, Sparks L, Thompson A, Earnest CP. Effects of aerobic and resistance training on hemoglobin A1c levels in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2010 Nov 24;304(20):2253–62. doi: 10.1001/jama.2010.1710. 304/20/2253
    1. Andrews RC, Cooper AR, Montgomery AA, Norcross AJ, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Bright J, Coulman K, England CY, Gorton J, McLenaghan A, Paxton E, Polet A, Thompson C, Dayan CM. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial. Lancet. 2011 Jul 09;378(9786):129–39. doi: 10.1016/S0140-6736(11)60442-X. S0140-6736(11)60442-X
    1. Balducci S, D'Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Vitale M, Bollanti L, Conti F, Zanuso S, Lucisano G, Nicolucci A, Pugliese G, Italian DiabetesExercise Study 2 (IDES_2) Investigators 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 Mar 05;321(9):880–890. doi: 10.1001/jama.2019.0922.2726985
    1. Look AHEAD Research Group. Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566–75. doi: 10.1001/archinternmed.2010.334.170/17/1566
    1. Ried-Larsen M, Johansen MY, MacDonald CS, Hansen KB, Christensen R, Wedell-Neergaard A, Pilmark NS, Langberg H, Vaag AA, Pedersen BK, Karstoft K. Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial. Diabetes Obes Metab. 2019 Oct;21(10):2257–2266. doi: 10.1111/dom.13802.
    1. Unick JL, Gaussoin SA, Hill JO, Jakicic JM, Bond DS, Hellgren M, Johnson KC, Peters AL, Coday M, Kitzman DW, Bossart S, Wing RR. Four-Year Physical Activity Levels among Intervention Participants with Type 2 Diabetes. Med Sci Sports Exerc. 2016 Dec;48(12):2437–2445. doi: 10.1249/MSS.0000000000001054.
    1. Umpierre D, Ribeiro PAB, Kramer CK, Leitão Cristiane B, Zucatti ATN, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 04;305(17):1790–9. doi: 10.1001/jama.2011.576.305/17/1790
    1. Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R, IDF Diabetes Atlas Committee Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9 edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843.S0168-8227(19)31230-6
    1. Gibala MJ, Little JP. Physiological basis of brief vigorous exercise to improve health. J Physiol. 2020 Jan;598(1):61–69. doi: 10.1113/JP276849. doi: 10.1113/JP276849.
    1. Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TPJ. 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 Feb;36(2):228–36. doi: 10.2337/dc12-0658. dc12-0658
    1. Ried-Larsen M, Thomsen RW, Berencsi K, Brinkløv Cecilie F, Brøns Charlotte, Valentiner LS, Karstoft K, Langberg H, Vaag AA, Pedersen BK, Nielsen JS. Implementation of interval walking training in patients with type 2 diabetes in Denmark: rationale, design, and baseline characteristics. Clin Epidemiol. 2016;8:201–9. doi: 10.2147/CLEP.S97303. doi: 10.2147/CLEP.S97303.clep-8-201
    1. Ashrafzadeh S, Hamdy O. Patient-Driven Diabetes Care of the Future in the Technology Era. Cell Metab. 2019 Mar 05;29(3):564–575. doi: 10.1016/j.cmet.2018.09.005. S1550-4131(18)30570-9
    1. Taylor K, Silver L. Smartphone ownership is growing rapidly around the world, but not always equally. Pew Research Center. 2019. [2022-04-11].
    1. Valentiner LS, Ried-Larsen M, Karstoft K, Brinkløv Cecilie Fau, Brøns Charlotte, Nielsen RO, Christensen R, Nielsen JS, Vaag AA, Pedersen BK, Langberg H. 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. BMJ Open. 2017 Apr 07;7(4):e014036. doi: 10.1136/bmjopen-2016-014036. bmjopen-2016-014036
    1. Valentiner LS, Thorsen IK, Kongstad MB, Brinkløv Cecilie Fau, Larsen RT, Karstoft K, Nielsen JS, Pedersen BK, Langberg H, Ried-Larsen M. Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial. PLoS One. 2019;14(1):e0208181. doi: 10.1371/journal.pone.0208181. PONE-D-18-07288
    1. Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1–72. doi: 10.1111/sms.12581.
    1. The Capital Region of Denmark Forløbsprogram for Type 2 Diabetes. Region Hovedstaden. [2022-04-11]. .
    1. Miller W, Rollnick S. Motivational interviewing: preparing people for change. 2nd ed. New York, NY: Guilford Press; 2002.
    1. Brønd Jan Christian, Aadland E, Andersen LB, Resaland GK, Andersen SA, Arvidsson D. The ActiGraph counts processing and the assessment of vigorous activity. Clin Physiol Funct Imaging. 2019 Jul;39(4):276–283. doi: 10.1111/cpf.12571.
    1. Toftager M, Kristensen P, Oliver M, Duncan S, Christiansen L, Boyle E, Brønd Jan Christian, Troelsen J. Accelerometer data reduction in adolescents: effects on sample retention and bias. Int J Behav Nutr Phys Act. 2013 Dec 23;10(1):140. doi: 10.1186/1479-5868-10-140. 1479-5868-10-140
    1. Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777–81. doi: 10.1097/00005768-199805000-00021.
    1. Petersen TL, Brønd Jan Christian, Kristensen PL, Aadland E, Grøntved Anders, Jepsen R. Resemblance in accelerometer-assessed physical activity in families with children: the Lolland-Falster Health Study. Int J Behav Nutr Phys Act. 2020 Dec 04;17(1):161. doi: 10.1186/s12966-020-01067-7. 10.1186/s12966-020-01067-7
    1. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220–33. doi: 10.1097/00005650-199603000-00003.
    1. Brinkløv Cecilie Fau, Thorsen IK, Karstoft K, Brøns Charlotte, Valentiner L, Langberg H, Vaag AA, Nielsen JS, Pedersen BK, Ried-Larsen M. 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. doi: 10.1186/s13102-016-0056-7.56
    1. 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 Jan;91(1):106–14. doi: 10.3945/ajcn.2009.28432.ajcn.2009.28432
    1. Markland D, Tobin V. A Modification to the Behavioural Regulation in Exercise Questionnaire to Include an Assessment of Amotivation. Journal of Sport and Exercise Psychology. 2004 Jun;26(2):191–196. doi: 10.1123/jsep.26.2.191.
    1. Skotte J, Korshøj Mette, Kristiansen J, Hanisch C, Holtermann A. Detection of physical activity types using triaxial accelerometers. J Phys Act Health. 2014 Jan;11(1):76–84. doi: 10.1123/jpah.2011-0347.2011-0347
    1. Ekelund U, Brage S, Griffin SJ, Wareham NJ, ProActive UK Research Group Objectively measured moderate- and vigorous-intensity physical activity but not sedentary time predicts insulin resistance in high-risk individuals. Diabetes Care. 2009 Jun;32(6):1081–6. doi: 10.2337/dc08-1895. dc08-1895
    1. Thorsen I, Yang Y, Ried-Larsen M. Long-term Effectiveness of Smartphone App-Delivered Interval Walking Training on Physical Activity Among Individuals with Type 2 Diabetes: SAP for the parallel-group, assessor-blinded, randomized InterWalk trial. The Centre for Physical Activity Research (CFAS) Website. [2022-04-11]. .
    1. Cao J, Zhang S. Multiple comparison procedures. JAMA. 2014 Aug 06;312(5):543–4. doi: 10.1001/jama.2014.9440.1892228
    1. Díaz-Arribas María J, Fernández-Serrano Mónica, Royuela A, Kovacs FM, Gallego-Izquierdo T, Ramos-Sánchez Mabel, Llorca-Palomera R, Pardo-Hervás Pedro, Martín-Pariente Oscar S. Minimal Clinically Important Difference in Quality of Life for Patients With Low Back Pain. Spine (Phila Pa 1976) 2017 Dec 15;42(24):1908–1916. doi: 10.1097/BRS.0000000000002298.00007632-201712150-00019
    1. van der Weegen Sanne, Verwey R, Spreeuwenberg M, Tange H, van der Weijden Trudy, de Witte Luc. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Jul 24;17(7):e184. doi: 10.2196/jmir.4579. v17i7e184
    1. Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 02;21(8):e13363. doi: 10.2196/13363. v21i8e13363
    1. Verwey R, van der Weegen Sanne, Spreeuwenberg M, Tange H, van der Weijden Trudy, de Witte Luc. A pilot study of a tool to stimulate physical activity in patients with COPD or type 2 diabetes in primary care. J Telemed Telecare. 2014 Jan;20(1):29–34. doi: 10.1177/1357633X13519057.1357633X13519057
    1. Plotnikoff RC, Wilczynska M, Cohen KE, Smith JJ, Lubans DR. Integrating smartphone technology, social support and the outdoor physical environment to improve fitness among adults at risk of, or diagnosed with, Type 2 Diabetes: Findings from the 'eCoFit' randomized controlled trial. Prev Med. 2017 Dec;105:404–411. doi: 10.1016/j.ypmed.2017.08.027.S0091-7435(17)30316-X
    1. MacDonald CS, Nielsen SM, Bjørner Jakob, Johansen MY, Christensen R, Vaag A, Lieberman DE, Pedersen BK, Langberg H, Ried-Larsen M, Midtgaard J. One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001840. doi: 10.1136/bmjdrc-2020-001840. 9/1/e001840
    1. Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 03;162(5):325–34. doi: 10.7326/M14-1189.2173500
    1. Ross R, Hudson R, Day AG, Lam M. Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods. Contemp Clin Trials. 2013 Jan;34(1):155–60. doi: 10.1016/j.cct.2012.10.010.S1551-7144(12)00237-6
    1. Benatti FB, Pedersen BK. Exercise as an anti-inflammatory therapy for rheumatic diseases-myokine regulation. Nat Rev Rheumatol. 2015 Feb;11(2):86–97. doi: 10.1038/nrrheum.2014.193.nrrheum.2014.193
    1. Griffin SJ, Simmons RK, Prevost AT, Williams KM, Hardeman W, Sutton S, Brage S, Ekelund U, Parker RA, Wareham NJ, Kinmonth AL, ADDITION-Plus study team Multiple behaviour change intervention and outcomes in recently diagnosed type 2 diabetes: the ADDITION-Plus randomised controlled trial. Diabetologia. 2014 Jul;57(7):1308–19. doi: 10.1007/s00125-014-3236-6.
    1. Sortsø Camilla, Lauridsen J, Emneus M, Green A, Jensen PB. Socioeconomic inequality of diabetes patients' health care utilization in Denmark. Health Econ Rev. 2017 Dec;7(1):21. doi: 10.1186/s13561-017-0155-5. 10.1186/s13561-017-0155-5
    1. Matthews CE, Keadle SK, Troiano RP, Kahle L, Koster A, Brychta R, Van Domelen D, Caserotti P, Chen KY, Harris TB, Berrigan D. Accelerometer-measured dose-response for physical activity, sedentary time, and mortality in US adults. Am J Clin Nutr. 2016 Nov;104(5):1424–1432. doi: 10.3945/ajcn.116.135129. ajcn.116.135129
    1. Falconer CL, Page AS, Andrews RC, Cooper AR. The Potential Impact of Displacing Sedentary Time in Adults with Type 2 Diabetes. Med Sci Sports Exerc. 2015 Oct;47(10):2070–5. doi: 10.1249/MSS.0000000000000651. 00005768-201510000-00008

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren