Type 2 DiabetesENERGISEDNCT05351359
mHealth Intervention to Increase Physical Activity in Prediabetes and Type 2 Diabetes
A study testing mHealth, phone counselling and Fitbit tracker in people with Type 2 Diabetes and PreDiabetes, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes
- What is being tested?
- mHealth, phone counselling and Fitbit tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Apr 2022to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- unable to walk
- pregnancy
- taking insulin
- living in a residential or nursing care home
- co-morbid conditions that would affect their adherence to the trial procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes
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.
- Conditions
- Type 2 Diabetes, PreDiabetes
- Being tested
- mHealth, phone counselling, Fitbit tracker, brief advice
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthBehavioural
A mHealth-enabled just-in-time adaptive intervention that is based on the HealthReact system developed by the participating centre at the Faculty of Science of the University of Hradec Kralove. The HealthReact system consists of a server-side application that is connected to the Fitbit server. As such, the system allows for just-in-time text messages triggered by pre-defined context as recorded by the Fitbit wearable monitor. For example, a prompt to take a break from sedentary behaviour can be triggered after 30 sedentary minutes, a suggestion to increase walking cadence can be triggered when continuous, but slow walking is detected, or a motivational message with a specific goal to take more steps to reach their usual daily step count can be triggered when the total daily steps are too low. The mHealth component will be delivered for the entire duration of the study (i.e., 12 months).
phone counsellingBehavioural
Regular monthly phone calls by trained counsellors support participants in their effort to increase physical activity and reduce sedentary behaviours. The counsellors will use various behaviour change techniques, such as goal-setting, feedback, action planning, etc. The phone counselling will be provided during the first six months, i.e. 6 phone calls will be delivered.
Fitbit trackerBehavioural
Fitbit Inspire 2 will be provided by the general practitioner to study participants at the start of the study to enable objective self-monitoring of physical activity.
brief adviceBehavioural
A brief advice will be provided by the general practitioner at the start of the study.
| Study group | Role | What they receive |
|---|---|---|
| Active control | Active comparator | The patients from the active control group will receive brief physical activity advice from their general practitioners at baseline, and they will also receive the Fitbit tracker to self-monitor their daily steps. Receives: Behavioral: Fitbit tracker; Behavioral: brief advice |
| Intervention | Experimental | The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. Receives: Behavioral: mHealth; Behavioral: phone counselling; Behavioral: Fitbit tracker; Behavioral: brief advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
step count
change in daily step count
Measured: from baseline to 12-month assessment
Secondary outcomes (14)
chair-stand test
functional 30s chair-stand test
Measured: at 6 and 12 months
HbA1c
haemoglobin A1c
Measured: at 6 and 12 months
glycemia
fasting plasma glucose
Measured: at 6 and 12 months
lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerids
Measured: at 12 months
step count
change in daily step count
Measured: at 6 months
physical behaviour - average acceleration
metric of physical activity volume
Measured: at 6 and 12 months
physical behaviour - intensity gradient
metric of physical activity intensity
Measured: at 6 and 12 months
sedentary time
time per day spent sedentary (in minutes)
Measured: at 6 and 12 months
sedentary bouts
time per day (in minutes) spent sedentary in bouts of 30 mins and longer
Measured: at 6 and 12 months
walking cadence
cadence (steps/min) in 5 (non-consecutive) highest-cadence minutes
Measured: at 6 and 12 months
blood pressure
systolic and diastolic blood pressure
Measured: at 6 and 12 months
Hospital Anxiety and Depression Scale (HADS)
symptoms of anxiety and depression: 14 items on a scale 0-3 (a higher score means a worse outcome)
Measured: at 6 and 12 months
Short Form Survey (SF-12)
measure of health-related quality of life: 12 items using various scales converted to a score 0-100 (a higher score means a better outcome)
Measured: at 6 and 12 months
body mass index
weigh in kilograms divided by height in meters squared
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start25 Apr 2022
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hradec Kralove, St George's, University of London, University of Leicester, University Ghent
- Responsible party
- Principal investigator, Tomáš Větrovský, Charles University, Czech Republic
- Investigators
- Bohumil Seifert, MD, PhD, Study chair, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351359
- Sponsor's protocol ID
- ENERGISED
- Acronym
- ENERGISED
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kral N, Vetrovsky T, Pfeiferova M, Seifert B, Capek V, Jurkova K, Steffl M, Cimler R, Kuhnova J, Ussher M, Wahlich C, Malisova K, Pelclova J, Dygryn J, Elavsky S, Maes I, Van Dyck D, Rowlands A, Yates T, Dvorak P, Harris T. Recruiting patients into a digital behavioural intervention in general practice: insights from the ENERGISED trial. BMC Prim Care. 2026 Mar 3;27(1):123. doi: 10.1186/s12875-026-03218-4.
PubMed 41772441Vetrovsky T, Kral N, Pfeiferova M, Seifert B, Capek V, Jurkova K, Steffl M, Cimler R, Kuhnova J, Harris T, Ussher M, Wahlich C, Malisova K, Pelclova J, Dygryn J, Elavsky S, Maes I, Van Dyck D, Rowlands A, Yates T. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan. Trials. 2025 May 20;26(1):166. doi: 10.1186/s13063-025-08865-z.
PubMed 40394706Vetrovsky T, Kral N, Pfeiferova M, Kuhnova J, Novak J, Wahlich C, Jaklova A, Jurkova K, Janek M, Omcirk D, Capek V, Maes I, Steffl M, Ussher M, Tufano JJ, Elavsky S, Van Dyck D, Cimler R, Yates T, Harris T, Seifert B. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial. BMC Public Health. 2023 Mar 31;23(1):613. doi: 10.1186/s12889-023-15513-1.
PubMed 36997936
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05351359
- Acronym / sponsor ID
- ENERGISED / ENERGISED
- Conditions
- Type 2 Diabetes, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University of Hradec Kralove, St George's, University of London, University of Leicester, University Ghent
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Behavioral: Fitbit tracker, Behavioral: brief adviceThe patients from the active control group will receive brief physical activity advice from their general practitioners at baseline, and they will also receive the Fitbit tracker to self-monitor their daily steps. |
| Intervention | Experimental | Behavioral: mHealth, Behavioral: phone counselling, Behavioral: Fitbit tracker, Behavioral: brief adviceThe patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- unable to walk
- pregnancy
- taking insulin
- living in a residential or nursing care home
- co-morbid conditions that would affect their adherence to the trial procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthA mHealth-enabled just-in-time adaptive intervention that is based on the HealthReact system developed by the participating centre at the Faculty of Science of the University of Hradec Kralove. The HealthReact system consists of a server-side application that is connected to the Fitbit server. As such, the system allows for just-in-time text messages triggered by pre-defined context as recorded by the Fitbit wearable monitor. For example, a prompt to take a break from sedentary behaviour can be triggered after 30 sedentary minutes, a suggestion to increase walking cadence can be triggered when continuous, but slow walking is detected, or a motivational message with a specific goal to take more steps to reach their usual daily step count can be triggered when the total daily steps are too low. The mHealth component will be delivered for the entire duration of the study (i.e., 12 months). | Behavioural | Intervention |
| phone counsellingRegular monthly phone calls by trained counsellors support participants in their effort to increase physical activity and reduce sedentary behaviours. The counsellors will use various behaviour change techniques, such as goal-setting, feedback, action planning, etc. The phone counselling will be provided during the first six months, i.e. 6 phone calls will be delivered. | Behavioural | Intervention |
| Fitbit trackerFitbit Inspire 2 will be provided by the general practitioner to study participants at the start of the study to enable objective self-monitoring of physical activity. | Behavioural | Active control, Intervention |
| brief adviceA brief advice will be provided by the general practitioner at the start of the study. | Behavioural | Active control, Intervention |
Primary outcome
step count
Time frame: from baseline to 12-month assessment
change in daily step count
14 secondary outcomes
chair-stand test
Time frame: at 6 and 12 months
HbA1c
Time frame: at 6 and 12 months
glycemia
Time frame: at 6 and 12 months
lipid profile
Time frame: at 12 months
step count
Time frame: at 6 months
physical behaviour - average acceleration
Time frame: at 6 and 12 months
physical behaviour - intensity gradient
Time frame: at 6 and 12 months
sedentary time
Time frame: at 6 and 12 months
sedentary bouts
Time frame: at 6 and 12 months
walking cadence
Time frame: at 6 and 12 months
blood pressure
Time frame: at 6 and 12 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: at 6 and 12 months
Short Form Survey (SF-12)
Time frame: at 6 and 12 months
body mass index
Time frame: at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 41772441Kral N, Vetrovsky T, Pfeiferova M, Seifert B, Capek V, Jurkova K, Steffl M, Cimler R, Kuhnova J, Ussher M, Wahlich C, Malisova K, Pelclova J, Dygryn J, Elavsky S, Maes I, Van Dyck D, Rowlands A, Yates T, Dvorak P, Harris T. Recruiting patients into a digital behavioural intervention in general practice: insights from the ENERGISED trial. BMC Prim Care. 2026 Mar 3;27(1):123. doi: 10.1186/s12875-026-03218-4.
- Derived from this study: PubMed 40394706Vetrovsky T, Kral N, Pfeiferova M, Seifert B, Capek V, Jurkova K, Steffl M, Cimler R, Kuhnova J, Harris T, Ussher M, Wahlich C, Malisova K, Pelclova J, Dygryn J, Elavsky S, Maes I, Van Dyck D, Rowlands A, Yates T. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan. Trials. 2025 May 20;26(1):166. doi: 10.1186/s13063-025-08865-z.
- Derived from this study: PubMed 36997936Vetrovsky T, Kral N, Pfeiferova M, Kuhnova J, Novak J, Wahlich C, Jaklova A, Jurkova K, Janek M, Omcirk D, Capek V, Maes I, Steffl M, Ussher M, Tufano JJ, Elavsky S, Van Dyck D, Cimler R, Yates T, Harris T, Seifert B. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial. BMC Public Health. 2023 Mar 31;23(1):613. doi: 10.1186/s12889-023-15513-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bohumil Seifert, MD, PhD study chair
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth, phone counselling and Fitbit tracker in people with Type 2 Diabetes and PreDiabetes, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
step count (time frame: from baseline to 12-month assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351359, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.