- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06181162
YoPA - A Youth-centred Participatory Action (YoPA)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leonie H Klaufus, Dr.
- Phone Number: 0031611037785
- Email: l.klaufus@amsterdamumc.nl
Study Contact Backup
- Name: Lara Martín Sánchez, Dr.
- Email: l.martinsanchez@amsterdamumc.nl
Study Locations
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Odense, Denmark
- Recruiting
- Syddansk Universitet, Research Unit for Active Living, Department of Sports Science and Clinical Biomechanics
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Contact:
- Jasper Schipperijn, Prof.Dr.
- Email: jschipperijn@health.sdu.dk
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Contact:
- Charlotte S Pawlowski, A/Prof.Dr.
- Email: cspawlowski@health.sdu.dk
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Amsterdam, Netherlands
- Recruiting
- Amsterdam UMC, location Vrije Universiteit Amsterdam, Public and Occupational Health
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Contact:
- Mai JM Chin A Paw, Prof.Dr.
- Email: m.chinapaw@amsterdamumc.nl
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Contact:
- Teatske M Altenburg, A/Prof.Dr.
- Email: t.altenburg@amsterdamumc.nl
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Osogbo, Nigeria
- Recruiting
- Redeemer's University, Department of Physiotherapy
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Contact:
- Adewale L Oyeyemi, A/Prof.Dr.
- Email: alaoyeyemi@yahoo.com
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Contact:
- Dayo R Omotoso, Dr.
- Email: omotosod@run.edu.ng
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Johannesburg, South Africa
- Recruiting
- University of the Witwatersrand, SAMRC Developmental Pathways for Health Research Unit, Faculty of Health Sciences
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Contact:
- Lisa J Ware, Dr.
- Email: lisa.ware@wits.ac.za
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Contact:
- Lauren Stuart, Dr.
- Email: lauren.stuart@wits.ac.za
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Adolescents growing up in vulnerable life situations in four diverse urban environments.
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To be determined in the co-creation groups at the four sites (Denmark, the Netherlands, Nigeria, South Africa)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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). |
Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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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.
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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).
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Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Agency
Time Frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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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.
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Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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Wellbeing
Time Frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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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.
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Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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Peer relationships
Time Frame: Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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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.
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Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mai JM Chin A Paw, Prof.Dr., Amsterdam UMC, location VUmc
- Principal Investigator: Teatske M Altenburg, A/Prof.Dr., Amsterdam UMC, location VUmc
- Principal Investigator: Jasper Schipperijn, Prof.Dr., Syddansk Universitet
- Principal Investigator: Charlotte S Pawlowski, A/Prof.Dr., Syddansk Universitet
- Principal Investigator: António L Palmeira, A/Prof.Dr., COFAC Cooperativa de Formacao e Animacao Cultural CRL
- Principal Investigator: Marlene Nunes Silva, A/Prof.Dr., COFAC Cooperativa de Formacao e Animacao Cultural CRL
- Principal Investigator: Adewale L Oyeyemi, A/Prof.Dr., Arizona State University
- Principal Investigator: Bruno Marchal, Prof.Dr., Instituut voor Tropische Geneeskunde
- Principal Investigator: Dayo Omotoso, Dr., Redeemer's University
- Principal Investigator: Lisa Ware, Dr., University of Witwatersrand, South Africa
- Principal Investigator: Lauren Stuart, Dr., WITS Health Hubb
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HORIZON Europe 101095423
- 101095423 (Other Grant/Funding Number: EU HORIZON-HLTH-2022-DISEASE-07-03)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Only anonimized data will be shared as well as additional supporting information, like a co-creation protocol, data dictionary code book, topic lists for focus groups and interviews, etc. All results will be integrated in an open access YoPA toolbox targeted at academic researchers, public health practitioners and authorities, policy makers, and citizens.
To request for data, a completed YoPA form "I want to reqest access to the YoPA data" should be submitted. Up to ten days after submission, the proposal will be evaluated by three members of the YoPA consortium.
Please check for more information the YoPA website: https://www.yopa-project.eu/
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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