NCT06181162

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3.2 years

First QC Date

November 20, 2023

Last Update Submit

September 11, 2025

Conditions

Keywords

Participatory Action ResearchHealth PromotionSystems ApproachAdolescents24-hour movement behaviourPhysical activityUrban health

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.

Secondary Outcomes (3)

  • Agency

    Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.

  • Wellbeing

    Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.

  • Peer relationships

    Pre-implementation, directly after implementation, and 3-6 months after implementation of the intervention.

Study Arms (1)

Adolescents growing up in vulnerable life situations in four diverse urban environments.

EXPERIMENTAL
Other: Social and/or physical environmental interventions

Interventions

To be determined in the co-creation groups at the four sites (Denmark, the Netherlands, Nigeria, South Africa)

Adolescents growing up in vulnerable life situations in four diverse urban environments.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Syddansk Universitet, Research Unit for Active Living, Department of Sports Science and Clinical Biomechanics

Odense, Denmark

RECRUITING

Amsterdam UMC, location Vrije Universiteit Amsterdam, Public and Occupational Health

Amsterdam, Netherlands

RECRUITING

Redeemer's University, Department of Physiotherapy

Osogbo, Nigeria

RECRUITING

University of the Witwatersrand, SAMRC Developmental Pathways for Health Research Unit, Faculty of Health Sciences

Johannesburg, South Africa

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38387985BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • 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
  • Adewale L Oyeyemi, A/Prof.Dr.

    Arizona State University

    PRINCIPAL INVESTIGATOR
  • Bruno Marchal, Prof.Dr.

    Instituut voor Tropische Geneeskunde

    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
  • Dayo Omotoso, Dr.

    Redeemer's University

    PRINCIPAL INVESTIGATOR
  • Lisa Ware, Dr.

    University of Witwatersrand, South Africa

    PRINCIPAL INVESTIGATOR
  • Lauren Stuart, Dr.

    WITS Health Hubb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonie H Klaufus, Dr.

CONTACT

Lara Martín Sánchez, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 26, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting from July 2024.
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/
More information

Locations