App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial

Stephanie E Bonn, Christina Alexandrou, Kristin Hjörleifsdottir Steiner, Klara Wiklander, Claes-Göran Östenson, Marie Löf, Ylva Trolle Lagerros, Stephanie E Bonn, Christina Alexandrou, Kristin Hjörleifsdottir Steiner, Klara Wiklander, Claes-Göran Östenson, Marie Löf, Ylva Trolle Lagerros

Abstract

Background: Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2.

Methods/design: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months.

Discussion: Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2.

Trial registration: ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017.

Keywords: Adults; Body composition; Exercise; HbA1c; Metabolic health; Randomized controlled trial; Smartphones.

Conflict of interest statement

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Flow-chart of the DiaCert-trial study design

References

    1. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(18):1343–1350. doi: 10.1056/NEJM200105033441801.
    1. Alberti KG, Zimmet P, Shaw J. International diabetes federation – a consensus on type 2 diabetes prevention. Diabet Med. 2007;24:451–463. doi: 10.1111/j.1464-5491.2007.02157.x.
    1. World Health Organization (WHO). Global Report on Diabetes 2016. World Health Organization 2016. ISBN: 9789241565257.
    1. Nordic Nutrition Recommendations 2012 (2014). Integrating nutrition and physical activity. 5th ed. Nord 2014:002. Copenhagen: Nordic Council of Ministers.
    1. Matthiessen J, Andersen LF, Barbieri HE, Borodulin K, Knudsen VK, Kørup K, et al. The Nordic monitoring system 2011–2014 - status and development of diet, physical activity, smoking, alcohol and overweight. TemaNord. 2016;561
    1. Blomster JI, Chow CK, Zoungas S, Woodward M, Patel A, Poulter NR, et al. The influence of physical activity on vascular complications and mortality in patients with type 2diabetes mellitus. Diabetes Obes Metab. 2013;15(11):1008–1012. doi: 10.1111/dom.12122.
    1. Zethelius B, Gudbjörnsdottir S, Eliasson B, Eeg-Olofsson K, Cederholm J. Swedish National Diabetes Register. Level of physical activity associated with risk of cardiovascular diseases and mortality in patients with type-2 diabetes: report from the Swedish National Diabetes Register. Eur J Prev Cardiol. 2014;21(2):244–251. doi: 10.1177/2047487313510893.
    1. Connelly J, Kirk A, Masthoff J, MacRury S. The use of technology to promote physical activity in type 2 diabetes management: a systematic review. Diabet Med. 2013;30:1420–1432. doi: 10.1111/dme.12289.
    1. Jennings CA, Vandelanotte C, Caperchione CM, Mummery WK. Effectiveness of a web-based physical activity intervention for adults with type 2 diabetes-arandomised controlled trial. Prev Med. 2014;60:33–40. doi: 10.1016/j.ypmed.2013.12.011.
    1. Schoeppe S, Alley S, Van Lippevelde W, Bray NA, Williams SL, Duncan MJ, et al. Efficacy of interventions that use apps to improve diet, physical activity and sedentary behavior: a systematic review. Int J Behav Nutr Phys Act. 2016;13(1):127. doi: 10.1186/s12966-016-0454-y.
    1. Davidsson P, Findahl O. The Swedes and the Internet 2016. [In Swedish: Svenskarna och internet 2016 - Undersökning om svenskarnas internetvanor] Internetstiftelsen i Sverige; 2016. Summary statistics avaliable in English:
    1. Bonoto BC, de Araújo VE, Godói IP, de Lemos LL, Godman B, Bennie M, et al. Efficacy of mobile apps to support the Care of Patients with Diabetes Mellitus: a systematic review and meta-analysis of randomized controlled trials. JMIR Mhealth Uhealth. 2017;5(3):e4. doi: 10.2196/mhealth.6309.
    1. Holmen H, Torbjørnsen A, Wahl AK, Jenum AK, Småstuen MC, Arsand E, et al. Mobile health intervention for self-management and lifestyle change for persons with type 2 diabetes, part 2: one-year results from the Norwegian randomized controlled trial RENEWINGHEALTH. JMIR Mhealth Uhealth. 2014;2(4):e57. doi: 10.2196/mhealth.3882.
    1. Waki K, Fujita H, Uchimura Y, Omae K, Aramaki E, Kato S, et al. DialBetics: a novel smartphone-based self-management support system for type 2 diabetes patients. J Diabetes Sci Technol. 2014;8(2):209–215. doi: 10.1177/1932296814526495.
    1. Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, et al. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011;365:1959–1968. doi: 10.1056/NEJMoa1108660.
    1. World Health Organization (WHO). mHealth: New horizons for health through mobile technologies: second global survey on eHealth. World Health Organization 2011. ISBN: 9789241564250.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c332.
    1. Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13(4):e126.
    1. Troiano RP, McClain JJ, Brychta RJ, Chen KY. Evolution of accelerometer methods for physical activity research. Br J Sports Med. 2014;48:1019–1023. doi: 10.1136/bjsports-2014-093546.
    1. Jeppsson JO, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T, et al. Approved IFCC reference method for measurement of HbA1c in human blood. Clin Chem Lab Med. 2002;40(1):78–89. doi: 10.1515/CCLM.2002.016.
    1. Landin-Olsson M, Jeppsson J-O, Nordin G. HbA1c – Ny standardisering införs i Sverige – Den nya enheten blir mmol/mol. [In Swedish] Läkartidningen. 2010;51–52:3282–85.
    1. Kecklund G, Åkerstedt T. The psychometric properties of the Karolinska sleep questionnaire. J Sleep Res. 1992;1(1):113. doi: 10.1111/j.1365-2869.1992.tb00005.x.
    1. Akerstedt T, Knutsson A, Westerholm P, Theorell T, Alfredsson L, Kecklund G. Sleep disturbances, work stress and work hours: a cross-sectional study. J Psychosom Res. 2002;53:741–748. doi: 10.1016/S0022-3999(02)00333-1.
    1. Socialstyrelsen. Nationella riktlinjer för sjukdomsförebyggande metoder. [In Swedish] The National Board of Health and Welfare, Sweden. 2011.
    1. Eyler AA, Brownson RC, Donatelle RJ, King AC, Brown D, Sallis JF. Physical activity social support and middle- and older-aged minority women: results from a US survey. Soc Sci Med. 1999;49(6):781–789. doi: 10.1016/S0277-9536(99)00137-9.
    1. Cohen S, Kamarck T, Mermelstein RA. Global measure of perceived stress. J Health Soc Behav. 1983;24:385–396. doi: 10.2307/2136404.
    1. Mujahid MS, Diez Roux AV, Morenoff JD, Raghunathan T. Assessing the measurement properties of neighborhood scales: from psychometrics to ecometrics. Am J Epidemiol. 2007;165(8):858–867. doi: 10.1093/aje/kwm040.
    1. Messerer M, Johansson SE, Wolk A. The validity of questionnaire-based micronutrient intake estimates is increased by including dietary supplement use in Swedish men. J Nutr. 2004;134(7):1800–1805.
    1. Sepp H, Becker W. Enkätfrågor om kost och fysisk aktivitet bland vuxna – Underlag till urval av frågor i befolkningsinriktade enkäter. [In Swedish] The National Food Agency, Sweden. 2004.
    1. Amsberg S, Wredling R, Lins PE, Adamson U, Johansson UB. The psychometric properties of the Swedish version of the problem areas in diabetes scale (Swe-PAID-20): scale development. Int J Nurs Stud. 2008;45(9):1319–1328. doi: 10.1016/j.ijnurstu.2007.09.010.
    1. Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001;33:350–357. doi: 10.3109/07853890109002089.
    1. Scheier MF, Wrosch C, Baum A, Cohen S, Martire LM, Matthews KA, et al. The life engagement test: assessing purpose in life. J Behav Med. 2006;29(3):291–298. doi: 10.1007/s10865-005-9044-1.
    1. Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: a review of reviews. Prev Med. 2015;76:56–67. doi: 10.1016/j.ypmed.2014.09.012.
    1. Van Dyck D, De Greef K, Deforche B, Ruige J, Bouckaert J, Tudor-Locke CE, et al. The relationship between changes in steps/day and health outcomes after a pedometer-based physical activity intervention with telephone support in type 2 diabetes patients. Health Educ Res. 2013;28(3):539–545. doi: 10.1093/her/cyt038.

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