Active Outdoor Play and Related Healthy Dietary BehavioursB-challengedNCT07136376
B-challenged: Co-creating Physical and Social Environments to Promote Children's Active Outdoor Play
A study testing Physical and social environmental interventions. in people with Active Outdoor Play and Related Healthy Dietary Behaviours, run by Amsterdam UMC, location VUmc at 5 sites in 5 countries.
Trial summary
BACKGROUND An alarmingly low number of children meet public health guidelines for physical activity and healthy dietary behaviours, and are at increased risk of developing lifestyle-related diseases. Importantly, this burden is already unequally distributed at an early age. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Outdoor Play and Related Healthy Dietary Behaviours
- What is being tested?
- Physical and social environmental interventions.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in a underserved urban neighbourhood
- Aged 9-12 years
- Inclusion criteria children participating in the effect evaluation:
- Living in the same underserved neighbourhood as the child co-researchers
- Aged 6-12 years
- Based on results of the actor mapping (including adult actors interview 1 and adult actors recruitment form)
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Germany1 site
University of Bremen, Leibniz Institute for Prevention Research and Epidemiology
Bremen
About this study
Official title: B-challenged: A Multi-actor Approach in Creating Safe and Attractive Physical and Social Environments to Promote Children's Active Outdoor Play and Healthy Dietary Behaviours
BACKGROUND An alarmingly low number of children meet public health guidelines for physical activity and healthy dietary behaviours, and are at increased risk of developing lifestyle-related diseases. Importantly, this burden is already unequally distributed at an early age. Unhealthy lifestyle behaviours are driven by complex mechanisms that differ across boys and girls growing up under different socio-economic circumstances. Outdoor play is an important contributor to children's levels of physical activity. Yet, children growing up in underprivileged neighbourhoods play less outside due to limited access to safe and attractive outdoor spaces and appropriate and affordable after school activities than other children. At the same time, today's children have abundant access to inexpensive energy-dense foods and online sedentary activities.
AIM B-challenged aims to tackle the complexity of equality in children's active outdoor play and healthy dietary behaviours by co-creating, implementing and evaluating interventions in the physical and social environmental together with children growing up in socio-economically underprivileged neighbourhoods and other key actors.
APPROACH B-challenged introduces a multi-actor, inter-sectorial democratic approach in five European countries (Denmark, Germany, Spain, Poland and the Netherlands), including all key actors (e.g. children, parents, teachers, policy makers). The investigators in B-Challenged will closely collaborate with all key actors, conduct analyses in European cohort data and consider the broader system (e.g. neighbourhood, family) as well as previous lessons-learned. Therewith, B-challenged aims at structural, relevant and feasible improvements in the physical and social environment promoting children's active outdoor play and dietary behaviours. B-challenged will impact all key actors in the selected neighbourhoods and far beyond through disseminating protocols and recommendations (research and policy) for upscaling the B-challenged approach.
- Being tested
- Physical and social environmental interventions.
- Keywords
- Participatory Action Research, System dynamics, Child co-researcher, Lifestyle behaviours, Multi-actor collaborations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and social environmental interventions.Other
To be determined in the co-creation groups at the five sites (Denmark, Germany, Poland, Spain, the Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Children growing up in underserved neighbourhoods. | Experimental | Not described Receives: Other: Physical and social environmental interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in outdoor play
Time spent in outdoor play is assessed by a child-questionnaire (based on HBSC questionnaire, US national Kids Survey, and nationwide survey from Norway) and covers active travel, organised outdoor activities and unorganised outdoor play.
Duration reported using 6 response options (longer duration of outdoor play contributing to a healthier lifestyle): 0-½ hour; ½-1 hour; 1-1 ½ hour; 1 ½-2 hours; and More than 2 hours.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation).
Secondary outcomes (8)
Frequency of fruit consumption during outdoor play, assessed by:
Child-questionnaire item on the frequency of consumption of fruits during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of fruit consumption contributes to a healthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of vegetable consumption during outdoor play, assessed by:
Child-questionnaire item on the frequency of consumption of vegetables during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of vegetable consumption contributes to a healthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of sweets during outdoor play, assessed by:
Child-questionnaire item on the frequency of consumption of sweets (candy or chocolate) during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of consumption of sweets contributes to a more unhealthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of crisps and other salty snacks during outdoor play, assessed by:
Child-questionnaire items on the frequency of consumption of crisps and other salty snacks during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of crisps and other salty snacks consumption contributes to a more unhealthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of coke or other soft drinks that contain sugar during outdoor play, assessed by:
Child-questionnaire items on the frequency of consumption of coke or other soft drinks that contain sugar during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of consumption of coke or other soft drinks that contain sugar contributes to a more unhealthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of fast-food (pizza, kebab, burgers) during outdoor play, assessed by:
Child-questionnaire items on the frequency of consumption of fast-food (pizza, kebab, burgers) during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of fast-food (pizza, kebab, burgers) consumption contributes to a more unhealthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of energy drinks (such as Red Bull) during outdoor play, assessed by:
Child-questionnaire items on the frequency of consumption of energy drinks (such as Red Bull) during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of energy drinks (such as Red Bull) consumption contributes to a more unhealthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of water during outdoor play, assessed by:
Child-questionnaire items on the frequency of consumption of water during outdoor play, partially based on the HBSC questionnaire, the US national Kids Survey and a nationwide survey from Norway.
Frequency reported on a 7-point scale: Never Less than once a week; Once a week; 2-4 days a week; 5-6 days a week; Once a day, every day; Every day, more than once.
Higher frequency of water consumption contributes to a healthy lifestyle.
Measured: Baseline and 12 months follow up (i.e., after intervention implementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active Outdoor Play and Related Healthy Dietary BehavioursStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Fundación Instituto Investigación Sanitaria Aragón, Zaragoza, Spain, Institute of Mother and Child, Warsaw, Poland, University of Bremen, Leibniz Institute for Prevention Research and Epidemiology, Bremen, Germany
- Responsible party
- Principal investigator, Teatske Altenburg, Amsterdam UMC, location VUmc
- Investigators
- Teatske Altenburg, A/Prof, Principal investigator, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136376
- Sponsor's protocol ID
- "HEALTHEQUITY-039 B-challenged
- Acronym
- B-challenged
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: B-Challenged uses the approach "as open as possible, as restricted as necessary" as the leading principle in providing open access to research data, which includes taking measures to make research data findable, accessible, interoperable and reusable.
Publications
Altenburg TM, Pawlowski CS, Ahrens W, Brand T, Buck C, Bornhorst C, Dzielska A, Klaufus L, De Miguel-Etayo P, Moreno L, Okulicz-Kozaryn K, Vrijkotte TGM, Wink R, Belmon LS, Chinapaw MJM. Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged project. BMJ Open. 2026 Mar 6;16(3):e108281. doi: 10.1136/bmjopen-2025-108281.
PubMed 41791787
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-challenged: A Multi-actor Approach in Creating Safe and Attractive Physical and Social Environments to Promote Children's Active Outdoor Play and Healthy Dietary Behaviours
- ClinicalTrials.gov ID
- NCT07136376
- Acronym / sponsor ID
- B-challenged / "HEALTHEQUITY-039 B-challenged
- Keywords
- Participatory Action Research, System dynamics, Child co-researcher, Lifestyle behaviours, Multi-actor collaborations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Fundación Instituto Investigación Sanitaria Aragón, Zaragoza, Spain, Institute of Mother and Child, Warsaw, Poland, University of Bremen, Leibniz Institute for Prevention Research and Epidemiology, Bremen, Germany
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Aug 2025 (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.
BACKGROUND An alarmingly low number of children meet public health guidelines for physical activity and healthy dietary behaviours, and are at increased risk of developing lifestyle-related diseases. Importantly, this burden is already unequally distributed at an early age. Unhealthy lifestyle behaviours are driven by complex mechanisms that differ across boys and girls growing up under different socio-economic circumstances. Outdoor play is an important contributor to children's levels of physical activity. Yet, children growing up in underprivileged neighbourhoods play less outside due to limited access to safe and attractive outdoor spaces and appropriate and affordable after school activities than other children. At the same time, today's children have abundant access to inexpensive energy-dense foods and online sedentary activities.
AIM B-challenged aims to tackle the complexity of equality in children's active outdoor play and healthy dietary behaviours by co-creating, implementing and evaluating interventions in the physical and social environmental together with children growing up in socio-economically underprivileged neighbourhoods and other key actors.
APPROACH B-challenged introduces a multi-actor, inter-sectorial democratic approach in five European countries (Denmark, Germany, Spain, Poland and the Netherlands), including all key actors (e.g. children, parents, teachers, policy makers). The investigators in B-Challenged will closely collaborate with all key actors, conduct analyses in European cohort data and consider the broader system (e.g. neighbourhood, family) as well as previous lessons-learned. Therewith, B-challenged aims at structural, relevant and feasible improvements in the physical and social environment promoting children's active outdoor play and dietary behaviours. B-challenged will impact all key actors in the selected neighbourhoods and far beyond through disseminating protocols and recommendations (research and policy) for upscaling the B-challenged approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children growing up in underserved neighbourhoods. | Experimental | Other: Physical and social environmental interventions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Living in a underserved urban neighbourhood
- Aged 9-12 years
- Living in the same underserved neighbourhood as the child co-researchers
- Aged 6-12 years
- Based on results of the actor mapping (including adult actors interview 1 and adult actors recruitment form)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical and social environmental interventions.To be determined in the co-creation groups at the five sites (Denmark, Germany, Poland, Spain, the Netherlands) | Other | Children growing up in underserved neighbourhoods. |
Primary outcome
Time spent in outdoor play
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation).
Time spent in outdoor play is assessed by a child-questionnaire (based on HBSC questionnaire, US national Kids Survey, and nationwide survey from Norway) and covers active travel, organised outdoor activities and unorganised outdoor play. Duration reported using 6 response options (longer duration of outdoor play contributing to a healthier lifestyle): 0-½ hour; ½-1 hour; 1-1 ½ hour; 1 ½-2 hours; and More than 2 hours.
8 secondary outcomes
Frequency of fruit consumption during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of vegetable consumption during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of sweets during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of crisps and other salty snacks during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of coke or other soft drinks that contain sugar during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of fast-food (pizza, kebab, burgers) during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of energy drinks (such as Red Bull) during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Frequency of consumption of water during outdoor play, assessed by:
Time frame: Baseline and 12 months follow up (i.e., after intervention implementation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 41791787Altenburg TM, Pawlowski CS, Ahrens W, Brand T, Buck C, Bornhorst C, Dzielska A, Klaufus L, De Miguel-Etayo P, Moreno L, Okulicz-Kozaryn K, Vrijkotte TGM, Wink R, Belmon LS, Chinapaw MJM. Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged project. BMJ Open. 2026 Mar 6;16(3):e108281. doi: 10.1136/bmjopen-2025-108281.
- Individual participant dataSharing planned: Yes. B-Challenged uses the approach "as open as possible, as restricted as necessary" as the leading principle in providing open access to research data, which includes taking measures to make research data findable, accessible, interoperable and reusable.
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.
Teatske Altenburg, A/Prof principal investigator
Amsterdam UMC, location VUmc, Amsterdam, the Netherlands
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and social environmental interventions. in people with Active Outdoor Play and Related Healthy Dietary Behaviours, run by Amsterdam UMC, location VUmc at 5 sites in 5 countries.
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 6 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Germany, Netherlands, Poland, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time spent in outdoor play (time frame: Baseline and 12 months follow up (i.e., after intervention implementation).). 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 NCT07136376, which also lists 1 linked publication.
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 22 Aug 2025.