Physical ActivityYoPANCT06181162
YoPA - A Youth-centred Participatory Action
A study testing Social and/or physical environmental interventions in people with Physical Activity and Health Promotion, run by Amsterdam UMC, location VUmc at 4 sites in 4 countries.
Trial summary
Background A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Promotion, Sleep
- What is being tested?
- Social and/or physical environmental interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Nov 2023to 31 Dec 2026
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged 12 to 18 years
- living in a disadvantaged area in Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), or Soweto (South Africa)
- active informed consent by the adolescents and at least one parent/caregiver where applicable for the participation of the adolescent
Who cannot join
- none
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Lara Martín Sánchez, Dr. contact
4 sites in 4 countries
Denmark1 site, 1 recruiting
- Recruiting
Syddansk Universitet, Research Unit for Active Living, Department of Sports Science and Clinical Biomechanics
Odense
Jasper Schipperijn, Prof.Dr., jschipperijn@health.sdu.dk
Charlotte S Pawlowski, A/Prof.Dr., cspawlowski@health.sdu.dk
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location Vrije Universiteit Amsterdam, Public and Occupational Health
Amsterdam
Mai JM Chin A Paw, Prof.Dr., m.chinapaw@amsterdamumc.nl
Teatske M Altenburg, A/Prof.Dr., t.altenburg@amsterdamumc.nl
Nigeria1 site, 1 recruiting
- Recruiting
Redeemer's University, Department of Physiotherapy
Osogbo
Adewale L Oyeyemi, A/Prof.Dr., alaoyeyemi@yahoo.com
Dayo R Omotoso, Dr., omotosod@run.edu.ng
South Africa1 site, 1 recruiting
- Recruiting
University of the Witwatersrand, SAMRC Developmental Pathways for Health Research Unit, Faculty of Health Sciences
Johannesburg
Lisa J Ware, Dr., lisa.ware@wits.ac.za
Lauren Stuart, Dr., lauren.stuart@wits.ac.za
About this study
Official title: YoPA - A Youth-centred Participatory Action Approach Towards Co-created Implementation of Socially and Physically Activating Environmental Interventions in Africa and Europe.
Background
A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations.
Read more
Methods
In diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner.
Discussion
YoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.
- Conditions
- Physical Activity, Health Promotion, Sleep, Screen Use
- Being tested
- Social and/or physical environmental interventions
- Keywords
- Participatory Action Research, Health Promotion, Systems Approach, Adolescents, 24-hour movement behaviour, Physical activity, Urban 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.
Social and/or physical environmental interventionsOther
To be determined in the co-creation groups at the four sites (Denmark, the Netherlands, Nigeria, South Africa)
| Study group | Role | What they receive |
|---|---|---|
| Adolescents growing up in vulnerable life situations in four diverse urban environments. | Experimental | Not described Receives: Other: Social and/or physical environmental interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-h movement behaviours (i.e., physical activity, sedentary behaviour and sleep).
24-h movement behaviours will be assesed by questionnaire and accelerometers.
The questionnaire contains questions on sleep (time spent on sleeping on a school day and weekend day, number of days feeling sleepy in the last week), physical activity (time spent in physical activity) and screentime (watching a screen on weekdays and weekend days).
Measured: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Physical activity and associated environmental characteristics in selected outdoor spaces
SOPLAY is a validated tool for directly observing physical activity and associated environmental characteristics in free play settings (e.g., recess and lunch at school). SOPLAY provides objective data on the number of participants and their physical activity levels during play and leisure opportunities in targeted areas. Separate scans are made for males and females, and simultaneous entries for contextual characteristics of areas including their accessibility, usability, and whether or not supervision, organized activities, and equipment are provided. The predominant type of activity engaged in by area users is also recorded (e.g., basketball, dance).
Measured: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Secondary outcomes (3)
Agency
Agency is assessed by two domains scales of the Global Early Adolescent Study (GEAS): voice and freedom of movement, The voice scale conists of seven items. the freedom of movement scale consists of six items. Each item is scored from 0 (never / rarely) to 2 (often), and each domain is scored as the mean of the items scores. Higher domain scores indicate a higher level of voice and freedom of movement.
Measured: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Wellbeing
Wellbeing is assessed by the PROMIS short form 8b Pediatric Life Satisfaction. This short form Pediatric Life Satisfaction consists of 8 items, which are scored from 1 (never) to 5 (almost always). Total scores are calculated by applying the original U.S. IRT model to the data and estimating the level of functioning of the patient (θ). This level of functioning is transformed into a T-score and is calculated by the formula (θ × 10) + 50, with higher scores representing higher levels of life satisfaction.
Measured: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Peer relationships
Peer relationships is assessed by the PROMIS short form 8a Pediatric Peer Relationships. The Pediatric Peer Relationships short form consists of 8 items, which are scored from 1 (never) to 5 (almost always). Total scores are calculated by applying the original U.S. IRT model to the data and estimating the level of functioning of the patient (θ). This level of functioning is transformed into a T-score and is calculated by the formula (θ × 10) + 50, with higher scores representing higher levels of peer relationships.
Measured: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Physical ActivityStudies 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
- Model description
- YoPA introduces teen-centred, evidence-informed co-creation to tackle the complex real-world challenge of unhealthy lifestyles and health inequalities. In urban environments in 'Minority World' countries (i.e., Denmark, the Netherlands) and 'Majority World' countries (i.e., Nigeria, South Africa), academic researchers will engage adolescents and other key stakeholders in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will be central in 1) mapping the local system, including needs and opportunities; 2) tailoring interventions to the local context; 3) implementing, and 4) evaluating interventions guided by our novel SUPER-AIM framework assessing local Systems, User perspective, Participatory co-creation process, Reach, Effects, Adoption, Implementation, and Maintenance of interventions in an integrated manner.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Alexander (the Netherlands), Syddansk Universitet, Denmark, Aalborg Municipality, University of Witwatersrand, South Africa, WITS Health Consortium (South Africa), Redeemer's University (Nigeria), Value Re-Orientation for Community Enhancement (Nigeria), Instituut voor Tropische Geneeskunde, Belgium, COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal), EMMA Communicatie B.V.
- Responsible party
- Principal investigator, Mai J M Chin A Paw, PhD, Amsterdam UMC, location VUmc
- Investigators
- Mai JM Chin A Paw, Prof.Dr., Principal investigator, Amsterdam UMC, location VUmcTeatske M Altenburg, A/Prof.Dr., Principal investigator, Amsterdam UMC, location VUmcJasper Schipperijn, Prof.Dr., Principal investigator, Syddansk UniversitetCharlotte S Pawlowski, A/Prof.Dr., Principal investigator, Syddansk UniversitetAdewale L Oyeyemi, A/Prof.Dr., Principal investigator, Arizona State UniversityBruno Marchal, Prof.Dr., Principal investigator, Instituut voor Tropische GeneeskundeAntónio L Palmeira, A/Prof.Dr., Principal investigator, COFAC Cooperativa de Formacao e Animacao Cultural CRLMarlene Nunes Silva, A/Prof.Dr., Principal investigator, COFAC Cooperativa de Formacao e Animacao Cultural CRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181162
- Sponsor's protocol ID
- HORIZON Europe 101095423
- Other IDs
- 101095423
- Acronym
- YoPA
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: YoPA 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
Chinapaw MJM, Klaufus LH, Oyeyemi AL, Draper C, Palmeira AL, Silva MN, Van Belle S, Pawlowski CS, Schipperijn J, Altenburg TM. Youth-centred participatory action approach towards co-created implementation of socially and physically activating environmental interventions in Africa and Europe: the YoPA project study protocol. BMJ Open. 2024 Feb 21;14(2):e084657. doi: 10.1136/bmjopen-2024-084657.
PubMed 38387985
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YoPA - A Youth-centred Participatory Action Approach Towards Co-created Implementation of Socially and Physically Activating Environmental Interventions in Africa and Europe.
- ClinicalTrials.gov ID
- NCT06181162
- Acronym / sponsor ID
- YoPA / HORIZON Europe 101095423
- Conditions
- Physical Activity, Health Promotion, Sleep, Screen Use
- Keywords
- Participatory Action Research, Health Promotion, Systems Approach, Adolescents, 24-hour movement behaviour, Physical activity, Urban health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Stichting Alexander (the Netherlands), Syddansk Universitet, Denmark, Aalborg Municipality, University of Witwatersrand, South Africa, WITS Health Consortium (South Africa), Redeemer's University (Nigeria), Value Re-Orientation for Community Enhancement (Nigeria), Instituut voor Tropische Geneeskunde, Belgium, COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal), EMMA Communicatie B.V.
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 2023 (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
A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations.
Methods
In diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner.
Discussion
YoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- YoPA introduces teen-centred, evidence-informed co-creation to tackle the complex real-world challenge of unhealthy lifestyles and health inequalities. In urban environments in 'Minority World' countries (i.e., Denmark, the Netherlands) and 'Majority World' countries (i.e., Nigeria, South Africa), academic researchers will engage adolescents and other key stakeholders in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will be central in 1) mapping the local system, including needs and opportunities; 2) tailoring interventions to the local context; 3) implementing, and 4) evaluating interventions guided by our novel SUPER-AIM framework assessing local Systems, User perspective, Participatory co-creation process, Reach, Effects, Adoption, Implementation, and Maintenance of interventions in an integrated manner.
| Arm | Type | Receives |
|---|---|---|
| Adolescents growing up in vulnerable life situations in four diverse urban environments. | Experimental | Other: Social and/or physical environmental interventions |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- aged 12 to 18 years
- living in a disadvantaged area in Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), or Soweto (South Africa)
- active informed consent by the adolescents and at least one parent/caregiver where applicable for the participation of the adolescent
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 |
|---|---|---|
| Social and/or physical environmental interventionsTo be determined in the co-creation groups at the four sites (Denmark, the Netherlands, Nigeria, South Africa) | Other | Adolescents growing up in vulnerable life situations in four diverse urban environments. |
Primary outcome
24-h movement behaviours (i.e., physical activity, sedentary behaviour and sleep).
Time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
24-h movement behaviours will be assesed by questionnaire and accelerometers. The questionnaire contains questions on sleep (time spent on sleeping on a school day and weekend day, number of days feeling sleepy in the last week), physical activity (time spent in physical activity) and screentime (watching a screen on weekdays and weekend days).
Physical activity and associated environmental characteristics in selected outdoor spaces
Time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
SOPLAY is a validated tool for directly observing physical activity and associated environmental characteristics in free play settings (e.g., recess and lunch at school). SOPLAY provides objective data on the number of participants and their physical activity levels during play and leisure opportunities in targeted areas. Separate scans are made for males and females, and simultaneous entries for contextual characteristics of areas including their accessibility, usability, and whether or not supervision, organized activities, and equipment are provided. The predominant type of activity engaged in by area users is also recorded (e.g., basketball, dance).
3 secondary outcomes
Agency
Time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Wellbeing
Time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
Peer relationships
Time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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 17 Sep 2025.
- Results publication: PubMed 38387985Chinapaw MJM, Klaufus LH, Oyeyemi AL, Draper C, Palmeira AL, Silva MN, Van Belle S, Pawlowski CS, Schipperijn J, Altenburg TM. Youth-centred participatory action approach towards co-created implementation of socially and physically activating environmental interventions in Africa and Europe: the YoPA project study protocol. BMJ Open. 2024 Feb 21;14(2):e084657. doi: 10.1136/bmjopen-2024-084657.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. YoPA 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.
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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.
Lara Martín Sánchez, Dr. contact
Mai JM Chin A Paw, Prof.Dr. principal investigator
Amsterdam UMC, location VUmc
Teatske M Altenburg, A/Prof.Dr. principal investigator
Amsterdam UMC, location VUmc
Jasper Schipperijn, Prof.Dr. principal investigator
Syddansk Universitet
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social and/or physical environmental interventions in people with Physical Activity and Health Promotion, run by Amsterdam UMC, location VUmc at 4 sites in 4 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 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Netherlands, Nigeria, South Africa. 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?
Contact Leonie H Klaufus, Dr. (0031611037785, l.klaufus@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-h movement behaviours (i.e., physical activity, sedentary behaviour and sleep). (time frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.). The study lists 2 primary outcomes in all. 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 NCT06181162, 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 17 Sep 2025.