Health and Wellbeing of Primary School-aged ChildrenHCCFNCT04193410
Healthy Childcare Centre of the Future
An observational study of Health and Wellbeing of Primary School-aged Children, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: In 2015-2020, the Dutch 'Healthy Primary School of the Future' intervention took place. Two schools became 'Healthy Primary Schools of the Future'; providing a healthy lunch and structured physical activity (PA) sessions. Two other 'Physical Activity Schools' only implemented the PA sessions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health and Wellbeing of Primary School-aged Children
- What is being tested?
- Various health-promoting initiatives
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 315 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jun 2020to 28 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: A closed design will be used, meaning that at baseline (T0), all children in study year four to six of the childcare centres will be invited to participate in the study. At T1, these children will be students in study year five to seven, and at T2 they will be in study year six to eight. Based on the amount of children enrolled in school year 2019/2020, approximately 685 children are eligible to participate in the study.
Who may be able to join
- Student from study years four to six (at baseline) at one of the the predetermined childcare centres
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: In 2015-2020, the Dutch 'Healthy Primary School of the Future' intervention took place. Two schools became 'Healthy Primary Schools of the Future'; providing a healthy lunch and structured physical activity (PA) sessions. Two other 'Physical Activity Schools' only implemented the PA sessions. The intervention showed promising effects on children's BMI z-score and dietary and PA behaviours. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future'. However, this is more complex than it seems to be, as budget to implement changes is lower and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved. No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of stakeholders.
Objective: To study the implementation of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the initiative's effects on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed. Data will be collected using questionnaires (parents, children, teachers, directors), anthropometric measures (children), interviews (teachers, directors), observations and analyses of minutes of meetings.
Read the detailed description
Rationale: From 2015-2020, the 'Healthy Primary School of the Future' intervention took place in Limburg, the Netherlands. The school environment of four primary schools changed. Two schools became 'Healthy Primary Schools of the Future'; providing their students with a healthy lunch and structured physical activity (PA) sessions during lunch time breaks. Two other 'Physical Activity Schools' only implemented the structured PA sessions. Interim analyses showed promising effects of the intervention; at two-year-follow-up, the study showed a significant decrease in BMI z-score of children in the 'Healthy Primary Schools of the Future' as compared with children in control schools. Also, positive intervention effects on dietary and PA behaviours were observed. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future' initiative. However, this is more complex than it seems to be, as budget to implement changes is lower than in the original trial, and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved (e.g., the school board, teachers, parents and children).
Objective: The main objective is to study the implementation process of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the effects of the 'Healthy Childcare Centre of the Future' on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed.
Study design: A non-randomised, non-controlled, observational study design. Study population: Children in study years four to six (at baseline) of twelve childcare centres located in Limburg, the Netherlands.
Main parameters/endpoints: The main study parameter of the effect evaluation is the change in absolute BMI z-score, which will be compared between the childcare centres categorised based on their degree of implementation (using categories based on the Diffusion of Innovations Theory).
Methods: Data will be collected in the form of questionnaires (parents, children, teachers/pedagogical employees, directors), anthropometric measurements (children), interviews (teachers/pedagogical employees, directors), observations and analyses of minutes of meetings.
Nature and extend of the burden and risks associated with participation: No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents. All outcome measures are non-invasive. The measurement protocol was designed while taking into account both a minimal burden for participants and a relevant scientific output for stakeholders (e.g., school board, teachers, parents/caregivers and children). Burden of participants is minimalised by incorporating most measurements in the regular school day.
- Being tested
- Various health-promoting initiatives
- Keywords
- Nutrition, Physical activity, School, Children, Prevention, School Health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various health-promoting initiativesBehavioural
No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents.
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-score
Children's Body Mass Index (BMI) was assessed by height and weight; age- and sex-specific BMI cut-off points were used to define overweight and obesity. BMI z-scores were calculated using Dutch reference values. A z-score of 0 represents the population mean. A z-score > 0 means a BMI higher than the population mean, a z-score of < 0 means a BMI lower than the population mean, both can pose specific health-related risks.
Measured: Two years
Secondary outcomes (12)
Mean Number of Days Per Week of Healthy Dietary Behaviours
A composite score for healthy dietary behaviours was computed from four separate questions. This score was calculated by averaging the weekly consumption (ranging from never (0) to every day (7)) of breakfast consumption and intake of fruit, warm and raw vegetables, and water throughout the day, as reported in the parental questionnaire.
Measured: Two years
Child Physical Activity Behaviour (Child-reported)
Assessed using the validated Physical Activity Questionnaire for Children (PAQ-C).The PAQ-C is a self-administered,7-day recall instrument, which provides a summary physical activity score derived from eight items, each scored on a 5-point scale. Item 1 (spare time activity) from no activity = 1; 7 times or more = 5. Items 2 to 7 (PE, lunch, right after school, evening, weekends) from lowest activity response = 1 or highest activity response = 5. Item 8 (mean of all days of the week) from none = 1; very often = 5. Item 9 (identifies students who are unusual active during the previous week). By adding up all means of the first eight items in PAQ-C, a summative score of physical activity is obtained. A score of 1 indicates low physical activity level, whereas a score of 5 indicates high physical activity level.
Measured: Two years
Child Waist Circumference
Waist circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.
Measured: Two years
Mean Number of Days Per Week of Soft Drink Consumption
Soft drink consumption during the past week was derived from the parental questionnaire ranging from never (0) to every day (7).
Measured: Two years
Water Consumption During School Hours
Water consumption during school hours was derived from the child questionnaire ranging from never (0) to every day (3).
Measured: Two years
Fruit Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Vegetable Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Grain Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Dairy Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Water Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Butter Consumption at Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
Measured: Two years
Consumption of at Least Two Healthy Food Groups During Lunch
The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter. To shed more light on the nutritional value of the children's lunches, the different food types consumed were summed, and a dichotomous variable was created indicating whether children consumed at least two of the food types during lunch.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Jun 2020
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health and Wellbeing of Primary School-aged ChildrenStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marla Hahnraths, MSc, Principal investigator, PhD candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193410
- Sponsor's protocol ID
- METCZ20190144
- Acronym
- HCCF
- Status last verified
- Jun 2023
- First submitted
- 3 Dec 2019
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not our intention to share individual participant data with other researchers
Publications
Bartelink NHM, Van Assema P, Jansen MWJ, Savelberg HHCM, Willeboordse M, Kremers SPJ. The Healthy Primary School of the Future: A Contextual Action-Oriented Research Approach. Int J Environ Res Public Health. 2018 Oct 12;15(10):2243. doi: 10.3390/ijerph15102243.
PubMed 30720796Willeboordse M, Jansen MW, van den Heijkant SN, Simons A, Winkens B, de Groot RH, Bartelink N, Kremers SP, van Assema P, Savelberg HH, de Neubourg E, Borghans L, Schils T, Coppens KM, Dietvorst R, Ten Hoopen R, Coomans F, Klosse S, Conjaerts MH, Oosterhoff M, Joore MA, Ferreira I, Muris P, Bosma H, Toppenberg HL, van Schayck CP. The Healthy Primary School of the Future: study protocol of a quasi-experimental study. BMC Public Health. 2016 Jul 26;16:639. doi: 10.1186/s12889-016-3301-9.
PubMed 27456845Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. Can the Healthy Primary School of the Future offer perspective in the ongoing obesity epidemic in young children? A Dutch quasi-experimental study. BMJ Open. 2019 Oct 31;9(10):e030676. doi: 10.1136/bmjopen-2019-030676.
PubMed 31676651Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study. Nutrients. 2019 Mar 22;11(3):689. doi: 10.3390/nu11030689.
PubMed 30909515
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Childcare Centre of the Future
- ClinicalTrials.gov ID
- NCT04193410
- Acronym / sponsor ID
- HCCF / METCZ20190144
- Keywords
- Nutrition, Physical activity, School, Children, Prevention, School Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: In 2015-2020, the Dutch 'Healthy Primary School of the Future' intervention took place. Two schools became 'Healthy Primary Schools of the Future'; providing a healthy lunch and structured physical activity (PA) sessions. Two other 'Physical Activity Schools' only implemented the PA sessions. The intervention showed promising effects on children's BMI z-score and dietary and PA behaviours. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future'. However, this is more complex than it seems to be, as budget to implement changes is lower and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved. No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of stakeholders.
Objective: To study the implementation of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the initiative's effects on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed. Data will be collected using questionnaires (parents, children, teachers, directors), anthropometric measures (children), interviews (teachers, directors), observations and analyses of minutes of meetings.
Detailed description
Rationale: From 2015-2020, the 'Healthy Primary School of the Future' intervention took place in Limburg, the Netherlands. The school environment of four primary schools changed. Two schools became 'Healthy Primary Schools of the Future'; providing their students with a healthy lunch and structured physical activity (PA) sessions during lunch time breaks. Two other 'Physical Activity Schools' only implemented the structured PA sessions. Interim analyses showed promising effects of the intervention; at two-year-follow-up, the study showed a significant decrease in BMI z-score of children in the 'Healthy Primary Schools of the Future' as compared with children in control schools. Also, positive intervention effects on dietary and PA behaviours were observed. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future' initiative. However, this is more complex than it seems to be, as budget to implement changes is lower than in the original trial, and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved (e.g., the school board, teachers, parents and children).
Objective: The main objective is to study the implementation process of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the effects of the 'Healthy Childcare Centre of the Future' on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed.
Study design: A non-randomised, non-controlled, observational study design. Study population: Children in study years four to six (at baseline) of twelve childcare centres located in Limburg, the Netherlands.
Main parameters/endpoints: The main study parameter of the effect evaluation is the change in absolute BMI z-score, which will be compared between the childcare centres categorised based on their degree of implementation (using categories based on the Diffusion of Innovations Theory).
Methods: Data will be collected in the form of questionnaires (parents, children, teachers/pedagogical employees, directors), anthropometric measurements (children), interviews (teachers/pedagogical employees, directors), observations and analyses of minutes of meetings.
Nature and extend of the burden and risks associated with participation: No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents. All outcome measures are non-invasive. The measurement protocol was designed while taking into account both a minimal burden for participants and a relevant scientific output for stakeholders (e.g., school board, teachers, parents/caregivers and children). Burden of participants is minimalised by incorporating most measurements in the regular school day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A closed design will be used, meaning that at baseline (T0), all children in study year four to six of the childcare centres will be invited to participate in the study. At T1, these children will be students in study year five to seven, and at T2 they will be in study year six to eight. Based on the amount of children enrolled in school year 2019/2020, approximately 685 children are eligible to participate in the study.
Key inclusion criteria (1 listed)
- Student from study years four to six (at baseline) at one of the the predetermined childcare centres
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Various health-promoting initiativesNo intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents. | Behavioural | – |
Primary outcome
BMI Z-score
Time frame: Two years
Children's Body Mass Index (BMI) was assessed by height and weight; age- and sex-specific BMI cut-off points were used to define overweight and obesity. BMI z-scores were calculated using Dutch reference values. A z-score of 0 represents the population mean. A z-score > 0 means a BMI higher than the population mean, a z-score of < 0 means a BMI lower than the population mean, both can pose specific health-related risks.
12 secondary outcomes
Mean Number of Days Per Week of Healthy Dietary Behaviours
Time frame: Two years
Child Physical Activity Behaviour (Child-reported)
Time frame: Two years
Child Waist Circumference
Time frame: Two years
Mean Number of Days Per Week of Soft Drink Consumption
Time frame: Two years
Water Consumption During School Hours
Time frame: Two years
Fruit Consumption at Lunch
Time frame: Two years
Vegetable Consumption at Lunch
Time frame: Two years
Grain Consumption at Lunch
Time frame: Two years
Dairy Consumption at Lunch
Time frame: Two years
Water Consumption at Lunch
Time frame: Two years
Butter Consumption at Lunch
Time frame: Two years
Consumption of at Least Two Healthy Food Groups During Lunch
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30720796Bartelink NHM, Van Assema P, Jansen MWJ, Savelberg HHCM, Willeboordse M, Kremers SPJ. The Healthy Primary School of the Future: A Contextual Action-Oriented Research Approach. Int J Environ Res Public Health. 2018 Oct 12;15(10):2243. doi: 10.3390/ijerph15102243.
- Background: PubMed 27456845Willeboordse M, Jansen MW, van den Heijkant SN, Simons A, Winkens B, de Groot RH, Bartelink N, Kremers SP, van Assema P, Savelberg HH, de Neubourg E, Borghans L, Schils T, Coppens KM, Dietvorst R, Ten Hoopen R, Coomans F, Klosse S, Conjaerts MH, Oosterhoff M, Joore MA, Ferreira I, Muris P, Bosma H, Toppenberg HL, van Schayck CP. The Healthy Primary School of the Future: study protocol of a quasi-experimental study. BMC Public Health. 2016 Jul 26;16:639. doi: 10.1186/s12889-016-3301-9.
- Background: PubMed 31676651Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. Can the Healthy Primary School of the Future offer perspective in the ongoing obesity epidemic in young children? A Dutch quasi-experimental study. BMJ Open. 2019 Oct 31;9(10):e030676. doi: 10.1136/bmjopen-2019-030676.
- Background: PubMed 30909515Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study. Nutrients. 2019 Mar 22;11(3):689. doi: 10.3390/nu11030689.
- Individual participant dataSharing planned: No. It is not our intention to share individual participant data with other researchers
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.
Marla Hahnraths, MSc principal investigator
PhD candidate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health and Wellbeing of Primary School-aged Children, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 16 Dec 2025. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BMI Z-score (time frame: Two years). 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 NCT04193410, which also lists 4 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 16 Dec 2025.