PMID- 35907864
OWN - NLM
STAT- MEDLINE
DCOM- 20220802
LR  - 20220803
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Jul 30
TI  - Activity tracker-based intervention to increase physical activity in patients 
      with type 2 diabetes and healthy individuals: study protocol for a randomized 
      controlled trial.
PG  - 617
LID - 10.1186/s13063-022-06550-z [doi]
LID - 617
AB  - BACKGROUND: One relevant strategy to prevent the onset and progression of type 2 
      diabetes mellitus (T2DM) focuses on increasing physical activity. The use of 
      activity trackers by patients could enable objective measurement of their regular 
      physical activity in daily life and promote physical activity through the use of 
      a tracker-based intervention. This trial aims to answer three research questions: 
      (1) Is the use of activity trackers suitable for longitudinal assessment of 
      physical activity in everyday life? (2) Does the use of a tracker-based 
      intervention lead to sustainable improvements in the physical activity of healthy 
      individuals and in people with T2DM? (3) Does the accompanying digital 
      motivational intervention lead to sustainable improvements in physical activity 
      for participants using the tracker-based device? METHODS: The planned study is a 
      randomized controlled trial focused on 1642 participants with and without T2DM 
      for 9 months with regard to their physical activity behavior. Subjects allocated 
      to an intervention group will wear an activity tracker. Half of the subjects in 
      the intervention group will also receive an additional digital motivational 
      intervention. Subjects allocated to the control group will not receive any 
      intervention. The primary outcome is the amount of moderate and vigorous physical 
      activity in minutes and the number of steps per week measured continuously with 
      the activity tracker and assessed by questionnaires at four time points. 
      Secondary endpoints are medical parameters measured at the same four time points. 
      The collected data will be analyzed using inferential statistics and explorative 
      data-mining techniques. DISCUSSION: The trial uses an interdisciplinary approach 
      with a team including sports psychologists, sports scientists, health scientists, 
      health care professionals, physicians, and computer scientists. It also involves 
      the processing and analysis of large amounts of data collected with activity 
      trackers. These factors represent particular strengths as well as challenges in 
      the study. TRIAL REGISTRATION: The trial is registered at the World Health 
      Organization International Clinical Trials Registry Platform via the German 
      Clinical Studies Trial Register (DRKS), DRKS00027064 . Registered on 11 November 
      2021.
CI  - (c) 2022. The Author(s).
FAU - Mahs, M
AU  - Mahs M
AUID- ORCID: 0000-0003-2157-2887
AD  - Institute of Gerontology, Vechta University, Vechta, Germany. 
      mareike.maehs@uni-vechta.de.
FAU - Pithan, J S
AU  - Pithan JS
AD  - Sport Science, Vechta University, Vechta, Germany.
FAU - Bergmann, I
AU  - Bergmann I
AD  - Institute of Gerontology, Vechta University, Vechta, Germany.
FAU - Gabrys, L
AU  - Gabrys L
AD  - University of Applied Sciences for Sport and Management Potsdam, Potsdam, 
      Germany.
FAU - Graf, J
AU  - Graf J
AD  - Institute of Gerontology, Vechta University, Vechta, Germany.
FAU - Holzemann, A
AU  - Holzemann A
AD  - Research group Ubiquitous Computing, University of Siegen, Siegen, Germany.
FAU - Van Laerhoven, K
AU  - Van Laerhoven K
AD  - Research group Ubiquitous Computing, University of Siegen, Siegen, Germany.
FAU - Otto-Hagemann, S
AU  - Otto-Hagemann S
AD  - Diabetologische Schwerpunktpraxis Dr. Silke Otto-Hagemann (diabetes center) 
      Vechta, Vechta, Germany.
FAU - Popescu, M L
AU  - Popescu ML
AD  - Diabetologische Schwerpunktpraxis Dr. Silke Otto-Hagemann (diabetes center) 
      Vechta, Vechta, Germany.
FAU - Schwermann, L
AU  - Schwermann L
AD  - Diabetologische Schwerpunktpraxis Dr. Silke Otto-Hagemann (diabetes center) 
      Vechta, Vechta, Germany.
FAU - Wenz, B
AU  - Wenz B
AD  - Institute of Gerontology, Vechta University, Vechta, Germany.
FAU - Pahmeier, I
AU  - Pahmeier I
AD  - Sport Science, Vechta University, Vechta, Germany.
FAU - Teti, A
AU  - Teti A
AUID- ORCID: 0000-0002-2112-4112
AD  - Institute of Gerontology, Vechta University, Vechta, Germany.
LA  - eng
GR  - VW-ZN-3426/Niedersachsisches Ministerium fur Wissenschaft und Kultur/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20220730
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - *Diabetes Mellitus, Type 2/diagnosis/therapy
MH  - Exercise
MH  - *Fitness Trackers
MH  - Humans
MH  - Motivation
MH  - Randomized Controlled Trials as Topic
MH  - Surveys and Questionnaires
PMC - PMC9338482
OTO - NOTNLM
OT  - Activity tracker
OT  - Diabetes
OT  - Motivation and volition
OT  - Physical activity
OT  - Randomized controlled trial
OT  - Wearables
COIS- The authors declare that they have no competing interests.
EDAT- 2022/07/31 06:00
MHDA- 2022/08/03 06:00
PMCR- 2022/07/30
CRDT- 2022/07/30 23:18
PHST- 2021/12/16 00:00 [received]
PHST- 2022/07/15 00:00 [accepted]
PHST- 2022/07/30 23:18 [entrez]
PHST- 2022/07/31 06:00 [pubmed]
PHST- 2022/08/03 06:00 [medline]
PHST- 2022/07/30 00:00 [pmc-release]
AID - 10.1186/s13063-022-06550-z [pii]
AID - 6550 [pii]
AID - 10.1186/s13063-022-06550-z [doi]
PST - epublish
SO  - Trials. 2022 Jul 30;23(1):617. doi: 10.1186/s13063-022-06550-z.