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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Type 2 Diabetes | Study protocol

Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial—the ROSEBUD study

Authors: M. B. Syrjälä, L. Bennet, P. C. Dempsey, E. Fharm, M. Hellgren, S. Jansson, S. Nilsson, M. Nordendahl, O. Rolandsson, K. Rådholm, A. Ugarph-Morawski, P. Wändell, P. Wennberg

Published in: Trials | Issue 1/2022

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Abstract

Background

Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM.

Methods

A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides.

Discussion

Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.

Trial registration

ClinicalTrials.gov NCT04219800. Registered on 7 January 2020.
Appendix
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Literature
1.
Jansson SP, Fall K, Brus O, Magnuson A, Wandell P, Ostgren CJ, et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319–28.PubMedCrossRef
2.
3.
Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, et al. Physical activity/exercise and diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2016;39(11):2065–79.PubMedPubMedCentralCrossRef
4.
Paing AC, McMillan KA, Kirk AF, Collier A, Hewitt A, Chastin SFM. Impact of free-living pattern of sedentary behaviour on intra-day glucose regulation in type 2 diabetes. Eur J Appl Physiol. 2020;120(1):171–9.PubMedCrossRef
5.
Dempsey PC, Dunstan DW, Larsen RN, Lambert GW, Kingwell BA, Owen N. Prolonged uninterrupted sitting increases fatigue in type 2 diabetes. Diabetes Res Clin Pract. 2018;01(135):128–33.CrossRef
6.
Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, et al. Benefits for type 2 diabetes of interrupting prolonged sitting with brief bouts of light walking or simple resistance activities. Diabetes Care. 2016;39(6):964–72.PubMedCrossRef
7.
8.
9.
Duvivier BM, Schaper NC, Hesselink MK, van Kan L, Stienen N, Winkens B, et al. Breaking sitting with light activities vs structured exercise: a randomised crossover study demonstrating benefits for glycaemic control and insulin sensitivity in type 2 diabetes. Diabetologia. 2017;60(3):490–8.PubMedCrossRef
10.
Dempsey PC, Blankenship JM, Larsen RN, Sacre JW, Sethi P, Straznicky NE, et al. Interrupting prolonged sitting in type 2 diabetes: nocturnal persistence of improved glycaemic control. Diabetologia. 2017;60(3):499–507.PubMedCrossRef
11.
Rebar AL, Duncan MJ, Short C, Vandelanotte C. Differences in health-related quality of life between three clusters of physical activity, sitting time, depression, anxiety, and stress. BMC Public Health. 2014;20(14):1088–1088.CrossRef
12.
Wennberg P, Boraxbekk CJ, Wheeler M, Howard B, Dempsey PC, Lambert G, et al. Acute effects of breaking up prolonged sitting on fatigue and cognition: a pilot study. BMJ Open. 2016;6(2):e009630-009630.PubMedPubMedCentralCrossRef
13.
Dempsey PC, Grace MS, Dunstan DW. Adding exercise or subtracting sitting time for glycaemic control: where do we stand? Diabetologia. 2017;60(3):390–4.PubMedCrossRef
14.
Dempsey PC, Owen N, Yates TE, Kingwell BA, Dunstan DW. Sitting less and moving more: improved glycaemic control for type 2 diabetes prevention and management. Curr Diab Rep. 2016;16(11):114–24.PubMedCrossRef
15.
16.
Pereira MA, Mullane SL, Toledo MJL, Larouche ML, Rydell SA, Vuong B, et al. Efficacy of the ‘Stand and Move at Work’ multicomponent workplace intervention to reduce sedentary time and improve cardiometabolic risk: a group randomized clinical trial. Int J Behav Nutr Phys Act. 2020;17(1):133.PubMedPubMedCentralCrossRef
17.
Hadgraft NT, Winkler E, Climie RE, Grace MS, Romero L, Owen N, et al. Effects of sedentary behaviour interventions on biomarkers of cardiometabolic risk in adults: systematic review with meta-analyses. Br J Sports Med. 2021;55(3):144–54.PubMedCrossRef
18.
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.PubMedCrossRef
19.
Rinaldi G, Hijazi A, Haghparast-Bidgoli H. Cost and cost-effectiveness of mHealth interventions for the prevention and control of type 2 diabetes mellitus: a systematic review. Diabetes Res Clin Pract. 2020;13:108084.CrossRef
20.
21.
Price K, Bird SR, Lythgo N, Raj IS, Wong JY, Lynch C. Validation of the Fitbit One, Garmin Vivofit and Jawbone UT activity tracker in estimation of energy expenditure during treadmill walking and running. J Med Eng Technol. 2017;41(#):208–15.PubMedCrossRef
22.
Steeves JA, Bowles HR, McClain JJ, Dodd KW, Brychta RJ, Wang J, et al. Ability of tight-worn ActiGraph and activPAL monitors to classify posture and motion. Med Sci Exerc. 2015;47(5):952–9.CrossRef
23.
Fortmann AL, Gallo LC, Garcia MI, Taleb M, Euyoque JA, Clark T, et al. Dulce Digital: an mHealth SMS-based intervention improves glycemic control in hispanics with type 2 diabetes. Diabetes Care. 2017;40(10):1349–55.PubMedPubMedCentralCrossRef
24.
25.
Hayes RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001;33(5):350–7.CrossRef
26.
Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, et al. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson’s method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4–0.PubMedCrossRef
27.
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.PubMedPubMedCentralCrossRef
28.
Miller WR, Rollnick S. Motivational interviewing: Helping people change. Guilford press, 2012.
29.
Prochaska JO, Velicer WF, Rossi JS, Goldstein MG, Marcus BH, Rakowski W, et al. Stages of change and decisional balance for 12 problem behaviors. Health Psychol. 1994;13(1):39–46.PubMedCrossRef
30.
Fisher L, Polonsky WH, Hessler D, Potter MB. A practical framework for encouraging and supporting positive behaviour change in diabetes. Diabet Med. 2017;34(12):1658–66.PubMedPubMedCentralCrossRef
31.
Bergman F, Wahlstrom V, Stomby A, Otten J, Lanthen E, Renklint R, et al. Treadmill workstations in office workers who are overweight or obese: a randomised controlled trial. Lancet Public Health. 2018;3(11):e523–35.PubMedCrossRef
32.
Moghetti P, Balducci S, Guidetti L, Mazzuca P, Rossi E, Schena F, et al. Walking for subjects with type 2 diabetes: A systematic review and joint AMD/SID/SISMES evidence-based practical guideline. Nutr Metab Cardiovasc Dis. 2020;30(11):1882–98.PubMedCrossRef
33.
Lamb MJE, Westgate K, Brage S, Ekelund U, Long GH, Griffin SJ, et al. Prospective associations between sedentary time, physical activity, fitness and cardiometabolic risk factors in people with type 2 diabetes. Diabetologia. 2016;59(1):110–20.PubMedCrossRef
34.
Mainsbridge CP, Cooley PD, Fraser SP, Pedersen SJ. The effect of an e-health intervention designed to reduce prolonged occupational sitting on mean arterial pressure. J Occup Environ Med. 2014;56(11):1189–94.PubMedPubMedCentralCrossRef
35.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
36.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208.PubMedPubMedCentralCrossRef
37.
38.
Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, et al. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016;388(10051):1302–10.PubMedCrossRef
39.
Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, et al. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020;54(24):1451–62.PubMedCrossRef
40.
Dempsey PC, Friedenreich CM, Leitzmann MF, Buman MP, Lambert E, Willumsen J, et al. Global public health guidelines on physical activity and sedentary behavior for people living with chronic conditions: a call to action. J Phys Act Health. 2020;18(1):76–85.PubMedCrossRef
41.
Dempsey PC, Biddle SJH, Buman MP, Chastin S, Ekelund U, Friedenreich CM, et al. New global guidelines on sedentary behaviour and health for adults: broadening the behavioural targets. Int J Behav Nutr Phys Act. 2020;17(1):151.PubMedPubMedCentralCrossRef
42.
Pronk NP. Implementing movement at the workplace: approaches to increase physical activity and reduce sedentary behavior in the context of work. Prog Cardiovasc Dis. 2021;01(64):17–21.CrossRef
43.
Metadata
Title
Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial—the ROSEBUD study
Authors
M. B. Syrjälä
L. Bennet
P. C. Dempsey
E. Fharm
M. Hellgren
S. Jansson
S. Nilsson
M. Nordendahl
O. Rolandsson
K. Rådholm
A. Ugarph-Morawski
P. Wändell
P. Wennberg
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Type 2 Diabetes
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06528-x

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