NCT05351359Completed
mHealth Intervention to Increase Physical Activity in Prediabetes and Type 2 Diabetes
mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
Sedentary behaviour has a detrimental effect on the mortality, morbidity, and well-being of patients with type 2 diabetes and prediabetes, and general practitioners should advise patients on how to self-monitor and increase their physical activity. The emergence of mobile health (mHealth) technologies unlocks the potential to further improve physical behaviour using an innovative "just-in-time" adaptive approach whereby behavioural support is provided in real-time, based on data from wearable sensors. Thus, the investigators aim to evaluate the effect of a just-in-time mHealth intervention administered by general practitioners on the physical activity and sedentary behaviour of patients with type 2 diabetes and prediabetes. A total of 340 patients will be recruited from 20 general practices across the Czech Republic and randomly assigned to either an active control or intervention group. Both groups will receive brief physical activity advice from their general practitioners and a Fitbit fitness tracker to self-monitor their daily steps, but the intervention group will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. The mHealth intervention will be delivered using a custom-developed system (HealthReact) connected to the Fitbit that will trigger just-in-time text messages. For example, a prompt to take a break from sedentary behaviour will be triggered after 30 sedentary minutes or a motivational message with a specific goal to take more steps will be triggered when the total step count is too low. The primary outcome will be the change in daily step count at 6 months, other outcomes include changes in other physical behaviour measures, blood tests, anthropometry and patient-reported outcomes at 6 and 12 months. If the intervention is effective, this study will provide a model of health prevention that can be directly implemented and commissioned within primary care using existing infrastructure.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 343 (actual)
- First submitted
- 19 Apr 2022
- Start date
- 25 Apr 2022
- Primary completion date
- 8 May 2025
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Type 2 diabetes
- NCT number
- NCT05351359
What you commit to
- Study type: Interventional
- Participants enrolled: 343
- From 25 Apr 2022 to the primary completion date, 8 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- co-morbid conditions that would affect their adherence to the trial procedures
Other
- unable to walk
- pregnancy
- taking insulin
- living in a residential or nursing care home
Who the study is looking for
- Diagnosis of prediabetes or T2DM according to the Czech guidelines for GPs on diabetes mellitus1 and prediabetes2, i.e. fasting plasma glucose 5.6-6.9 mmol/l, or 2-h plasma glucose of 7.8-11.0 mmol/l after ingestion of 75 g of oral glucose load for the diagnosis of prediabetes, and fasting plasma glucose ≥ 7.0 mmol/l, or 2-h plasma glucose ≥ 11.1 mmol/l after ingestion of 75 g of the oral glucose load for the diagnosis of T2DM
- Age 18 years or older.
- Registered at a participating general practice.
- Regular users of a smartphone and willing to use it as part of the study.
- Written informed consent obtained before any assessment related to the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of General Practice Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
Related publications
- Recruiting patients into a digital behavioural intervention in general practice: insights from the ENERGISED trial.BMC Prim Care · 2026 · PMID 41772441
This page is information, not medical advice. Discuss any trial with your doctor.