Activity tracker-based intervention to increase physical activity in patients with type 2 diabetes and healthy individuals: study protocol for a randomized controlled trial
Open accessAbstract
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.
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Maintaining physical activity can aid in glycemic control, while a decrease in physical activity can contribute to a deterioration in glycemic control.
“Our findings align with the literature, which demonstrates that maintaining physical activity can aid in glycemic control, while a decrease in physical activity can contribute to a deterioration in glycemic control [13, 17].”
From Sequential use of continuous glucose monitoring, with or without exercise trackers, significantly improves glycemic control in patients with type 2 diabetes (2025) · cites this paper as [17]
The Introduction (Background and rationale; page unavailable) reports that physical activity can reduce fasting glucose and HbA1c, supporting the glycemic-control benefit. It also compares higher with lower activity levels, but does not establish that a decrease in an individual's activity over time causes glycemic control to deteriorate. (LLM, conf=0.83)
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Research works printed but not linked: 1
- [25]Van Laerhoven K Gellersen H Malliaris Y Long-Term Activity Monitoring with a Wearable Sensor Node. 3rd Intl Workshop on Body Sensor Nodes 2006 Boston IEEE Press
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- Authors
- Mähs, M., Pithan, J. S., Bergmann, I., Gabrys, L., Graf, J., Hölzemann, A., Van Laerhoven, K., Otto-Hagemann, S., Popescu, M. L., Schwermann, L., Wenz, B., Pahmeier, I., & Teti, A.
- Affiliations
- University of Vechta (DE)
- University of Applied Sciences Potsdam (DE)
- University of Siegen (DE)
- Corresponding author
- Mähs, M.
- Venue
- Trials
- Published
- 2022-07-30
- Volume
- 23
- Issue
- 1
- Pages
- 617-617
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC9338482
- OpenAlex
- W4288748532
- Cited by
- 4
- References
- 72
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 2
- FWCI
- 0.62
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- Research Square (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Niedersächsisches Ministerium für Wissenschaft und Kultur (VW-ZN-3426)
- Universität Vechta
- Topics
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Physical Sciences › Computer Science › Computer Vision and Pattern Recognition › Context-Aware Activity Recognition Systems
- Keywords
- wearable activity trackers, physical activity, type 2 diabetes, moderate-to-vigorous physical activity, step count, exercise behavior change, wearable devices, diabetes prevention
- MeSH terms
- Fitness Trackers, Diabetes Mellitus, Type 2, Humans, Motivation, Surveys and Questionnaires, Exercise, Randomized Controlled Trials as Topic
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