HealthyMILESTONENCT06394141
MILESTONE - MobILe and tEchnological SoluTions for OccupatioNal drivErs
A study testing Real-time triggers, Personalized tailored feedback and Real-time triggers + Personalized tailored feedback in people with Healthy, run by Hasselt University at 1 site in Belgium.
Trial summary
Professional drivers in freight transport often experience difficult, exhausting and stressful working conditions due to various reasons: irregular sleep patterns, uncertainty in traffic, frequently changing schedules, busy schedules, a lot of time away from home, etc. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real-time triggers, Personalized tailored feedback and Real-time triggers + Personalized tailored feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2022to Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Working as long-haul, short-haul, or local delivery driver (in a transport company or self-employed)
- Having a smartphone
- Dutch-speaking
Who cannot join
- No excessive alcohol use
- No drugs use
- Not having an infectious disease
- Not being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MILESTONE: MobILe and tEchnological SoluTions for OccupatioNal drivErs
Professional drivers in freight transport often experience difficult, exhausting and stressful working conditions due to various reasons: irregular sleep patterns, uncertainty in traffic, frequently changing schedules, busy schedules, a lot of time away from home, etc. These working conditions can lead to significant health problems with a significant impact on road safety. According to the International Road Transport Union, Europe is currently facing the most acute driver shortage in decades; which threatens the continued growth of the road transport sector, and its ability to provide solutions to expected volume growth. Technology will play an important role in making road transport safer and more efficient. MILESTONE\'s overall objective is to develop and test technological interventions which are expected to reduce the difficult working conditions, stress, negative health effects of professional drivers.
Read the detailed description
The overall objective of MILESTONE is to develop and test technological interventions to reduce the difficult working conditions, stress, negative health effects of professional drivers.
- Understanding the impact of personal state and contextual stress on driving behavior and road safety, and aims to analyze the relationship between physiological and mental state (e.g., sleep quality, fatigue, sleepiness, stress, thermal comfort), general health status, work-related factors, external stressors, and driving parameters linked to road safety.
- Developing an intervention to keep drivers within their \"stress tolerance zone\" (STZ) (personal zone within which stress is acceptable)
- Analyzing the impact of the MILESTONE interventions for different categories of drivers (long-haul, short-haul and local delivery), compared to an active and passive control group
- Conditions
- Healthy
- Being tested
- Real-time triggers, Personalized tailored feedback, Real-time triggers + Personalized tailored feedback, App-supported exercise therapy, Conventional intervention
- Keywords
- Occupational freight drivers, Stress reduction, Technological interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time triggersBehavioural
The first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of \'energy-takers\' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels
Personalized tailored feedbackBehavioural
The second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life.
Real-time triggers + Personalized tailored feedbackBehavioural
The third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups.
App-supported exercise therapyBehavioural
The fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc.
Conventional interventionBehavioural
The active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Real-time triggers | Experimental | The first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of 'energy-takers' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels. Receives: Behavioral: Real-time triggers |
| Personalized tailored feedback | Experimental | The second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life. Receives: Behavioral: Personalized tailored feedback |
| Real-time triggers + Personalized tailored feedback | Experimental | The third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups. Receives: Behavioral: Real-time triggers + Personalized tailored feedback |
| App-supported exercise therapy | Experimental | The fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc. Receives: Behavioral: App-supported exercise therapy |
| Conventional intervention | Active comparator | The active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness. Receives: Behavioral: Conventional intervention |
| Control group | No intervention | The passive control group (n= 20 professional drivers) will get no intervention and will continue as normal without receiving any feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated heart rate-based load measure (average of all trips during past 2 weeks)
Mental load (derived from the energy balance estimation, as an indication of stress), measured by accumulated heart rate-based load measure via wearable (average of all trips during past 2 weeks)
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Secondary outcomes (8)
Work Ability Index
A summary measure of 7 items (e.g., the demands of work, the worker's health status and resources) identifying the health risks and risks of early retirement. The final WAI score is calculated as the total unweighted score covering the WAI's seven dimensions, or indicators. The combination of dimension values results in a total WAI score that can range from 7 (unable to work) to 49 (full work ability).
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
36-item Short Form Healthy Survey
Measuring health-related quality of life, consisting of both a physical and mental component. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Perceived Stress Scale 10
Measuring perceived stress. The questions ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never = 0; Almost never = 1; Sometimes = 2; Fairly often = 3; Very often = 4. To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 => 4; 1 => 3; 2 => 2; 3 => 1; 4 => 0). The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Driving Behaviour Inventory - General Driver Stress
A 16-item instrument extracted from the Driver Behaviour Inventory that measures general driver stress. The DBI-Gen consists of 16 items that tap a general disposition, or "trait" susceptibility, to driver stress. Responses are made on a Likert scale ranging from 0 to 100, indicating the level of agreement with each statement. Scoring consisted of the mean response to the 16 tems, with higher scores indicating greater trait driver stress susceptibility.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
General Self-Efficacy Scale
Measuring a broad and stable sense of personal competence to deal effectively with a variety of stressful situations. The total score is calculated by finding the sum of all 10 items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Depression Anxiety Stress Scales
A 42-item self-report instrument designed to measure the related negative emotional states of depression, anxiety, tension/stress.The DASS assesses negative emotional symptoms by using a 4-point Likert scale, ranging from 0 to 3. It has 3 subscales (depression, anxiety, and stress) with 14 items in each subscale for the DASS 42. These subscales are scored by the addition of the total item scores, which can range from 0 to 42. Maximum score: 126 for the 42-item DASS. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Fatigue Assessment Scale
A short, valid, reliable and easy to administer unidimensional fatigue questionnaire. The FAS is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. An answer to every question has to be given, even if the person does not have any complaints at the moment. Scores on question 4 and 10 should be recoded (1=5, 2=4, 3=3, 4=2, 5=1). Subsequently, the total FAS score can be calculated by summing the scores on all questions (recoded scores for questions 4 and 10). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Epworth Sleepiness Scale
To measure daytime sleepiness, asking the subject how likely he/she is to doze off or fall asleep in different situations of everyday life. The test is a list of eight situations in which the respondents rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All answers to the questions need to be added.The total score is based on a scale of 0 to 24, with a higher score means a higher respondent's sleepiness.
Measured: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Dec 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, An Neven, Hasselt University
- Investigators
- An Neven, PhD, Principal investigator, Hasselt University - Transportation Research Institute (IMOB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394141
- Sponsor's protocol ID
- MILESTONE
- Other IDs
- HBC.2021.0387
- Acronym
- MILESTONE
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MILESTONE: MobILe and tEchnological SoluTions for OccupatioNal drivErs
- ClinicalTrials.gov ID
- NCT06394141
- Acronym / sponsor ID
- MILESTONE / MILESTONE
- Conditions
- Healthy
- Keywords
- Occupational freight drivers, Stress reduction, Technological interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 1 May 2024 (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.
Professional drivers in freight transport often experience difficult, exhausting and stressful working conditions due to various reasons: irregular sleep patterns, uncertainty in traffic, frequently changing schedules, busy schedules, a lot of time away from home, etc. These working conditions can lead to significant health problems with a significant impact on road safety. According to the International Road Transport Union, Europe is currently facing the most acute driver shortage in decades; which threatens the continued growth of the road transport sector, and its ability to provide solutions to expected volume growth. Technology will play an important role in making road transport safer and more efficient. MILESTONE\'s overall objective is to develop and test technological interventions which are expected to reduce the difficult working conditions, stress, negative health effects of professional drivers.
Detailed description
The overall objective of MILESTONE is to develop and test technological interventions to reduce the difficult working conditions, stress, negative health effects of professional drivers.
- Understanding the impact of personal state and contextual stress on driving behavior and road safety, and aims to analyze the relationship between physiological and mental state (e.g., sleep quality, fatigue, sleepiness, stress, thermal comfort), general health status, work-related factors, external stressors, and driving parameters linked to road safety.
- Developing an intervention to keep drivers within their \"stress tolerance zone\" (STZ) (personal zone within which stress is acceptable)
- Analyzing the impact of the MILESTONE interventions for different categories of drivers (long-haul, short-haul and local delivery), compared to an active and passive control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Real-time triggers | Experimental | Behavioral: Real-time triggersThe first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of 'energy-takers' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels. |
| Personalized tailored feedback | Experimental | Behavioral: Personalized tailored feedbackThe second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life. |
| Real-time triggers + Personalized tailored feedback | Experimental | Behavioral: Real-time triggers + Personalized tailored feedbackThe third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups. |
| App-supported exercise therapy | Experimental | Behavioral: App-supported exercise therapyThe fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc. |
| Conventional intervention | Active comparator | Behavioral: Conventional interventionThe active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness. |
| Control group | No intervention | –The passive control group (n= 20 professional drivers) will get no intervention and will continue as normal without receiving any feedback. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Working as long-haul, short-haul, or local delivery driver (in a transport company or self-employed)
- Having a smartphone
- Dutch-speaking
Key exclusion criteria (4 listed)
- No excessive alcohol use
- No drugs use
- Not having an infectious disease
- Not being pregnant
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 |
|---|---|---|
| Real-time triggersThe first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of \'energy-takers\' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels | Behavioural | Real-time triggers |
| Personalized tailored feedbackThe second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life. | Behavioural | Personalized tailored feedback |
| Real-time triggers + Personalized tailored feedbackThe third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups. | Behavioural | Real-time triggers + Personalized tailored feedback |
| App-supported exercise therapyThe fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc. | Behavioural | App-supported exercise therapy |
| Conventional interventionThe active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness. | Behavioural | Conventional intervention |
Primary outcome
Accumulated heart rate-based load measure (average of all trips during past 2 weeks)
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Mental load (derived from the energy balance estimation, as an indication of stress), measured by accumulated heart rate-based load measure via wearable (average of all trips during past 2 weeks)
8 secondary outcomes
Work Ability Index
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
36-item Short Form Healthy Survey
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Perceived Stress Scale 10
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Driving Behaviour Inventory - General Driver Stress
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
General Self-Efficacy Scale
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Depression Anxiety Stress Scales
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Fatigue Assessment Scale
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Epworth Sleepiness Scale
Time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- MILESTONE websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. GDPR
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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.
An Neven, PhD principal investigator
Hasselt University - Transportation Research Institute (IMOB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time triggers, Personalized tailored feedback and Real-time triggers + Personalized tailored feedback in people with Healthy, run by Hasselt University at 1 site in Belgium.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Accumulated heart rate-based load measure (average of all trips during past 2 weeks) (time frame: At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2024.