YoPA - A Youth-centred Participatory Action

Physical Activity Clinical Trial

— YoPA  

Official title:

YoPA - A Youth-centred Participatory Action Approach Towards Co-created Implementation of Socially and Physically Activating Environmental Interventions in Africa and Europe.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181162
• Other study ID #: HORIZON Europe 101095423
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Leonie H Klaufus, Dr.
• Phone: 0031611037785
• Email: l.klaufus[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• aged 12 to 19 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

Related Conditions & MeSH terms

• Health Promotion
• Physical Activity
• Sleep

Intervention

Other:
• Social and/or physical environmental interventions
To be determined in the co-creation groups on the four sites (Denmark, the Netherlands, Nigeria, South Africa)

Locations

Country	Name	City	State
Denmark	Syddansk Universitet, Research Unit for Active Living, Department of Sports Science and Clinical Biomechanics	Odense
Netherlands	Amsterdam UMC, location Vrije Universiteit Amsterdam, Public and Occupational Health	Amsterdam
Nigeria	Redeemer's University, Department of Physiotherapy	Ede
South Africa	University of the Witwatersrand, SAMRC Developmental Pathways for Health Research Unit, Faculty of Health Sciences	Johannesburg

Sponsors (10)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Aalborg Kommune (Denmark), COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal), Instituut voor Tropische Geneeskunde, Belgium, Redeemer's University (Nigeria), Stichting Alexander (the Netherlands), Syddansk Universitet, Denmark, University of the Witwatersrand Johannesburg (South Africa), Value Re-Orientation for Community Enhancement (Nigeria), WITS Health Consortium (South Africa)

Countries where clinical trial is conducted

Denmark,  Netherlands,  Nigeria,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 24-h movement behaviours (i.e., percentages of moderate to vigorous physical activity, sendetary behaviour and sleep) as assessed by accelerometers.	Changes in 24-h movement behaviours will be assesed by accelerometers, worn by adolescents in the evaluation sample (n=200). These adolescents will wear the accelerometer for at least seven consecutive days on three time points: before, directly after, and 12 months after implementation of the intervention.	Up to 12 months after implementation of the intervention.
Primary	Changes in number of adolescents visiting the observed space as assessed by the System for Observing Play and Leisure Active in Youth (SOPLAY) observation instrument.	The SOPLAY will be completed on the four sites: Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), and Soweto (South Africa).	Up to 12 months after implementation of the intervention.
Primary	Changes in number of adolescents engaged in moderate to vigorous physical activity as assessed by the System for Observing Play and Leisure Active in Youth (SOPLAY) observation instrument.	The SOPLAY will be completed on the four sites: Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), and Soweto (South Africa). It will be completed academic and/or adolescent researchers on three time points: before, directly after, and 12 months after implementation of the intervention.	Up to 12 months after implementation of the intervention.
Secondary	Changes in agency as assessed by the Global Early Adolescent Study (GEAS) questionnaire.	The outcome measure is a profile across three domains (i.e., voice, freedom of movement, and behavioural control and decision making). The freedom of movement scale consists of six items, the voice scale conists of seven items, and the behavioural control and decision making scale consitsts of seven items. Each item is scored from 0 (never / rarely) to 2 (often), and each domain is scored as the mean of the concerned items scores. Higher domain scores indicate a higher level of freedom of movement, voice and behavioural control and decision making. The GEAS will be completed by adolescents in the evaluation sample on three time points: before, directly after, and 12 months after implementation of the intervention.	Up to 12 months after implementation of the intervention.
Secondary	Changes in wellbeing as assessed by the Engagement, Perseverance, Optimism, Connectedness, Happiness (EPOCH) questionnaire.	The outcome measure is a profile across five domains (i.e., engagement, perseverance, optimism, connectedness, happiness). Each domain consists of four items, which are scored from 1 (almost never / not at all like me) to 5 (almost always / very much like me), and the mean of those four scores indicate the domain score. Higher domain scores indicate higher levels of engagement, perseverance, optimism, connectedness or happiness. The EPOCH will be completed by adolescents in the evaluation sample on three time points: before, directly after, and 12 months after implementation of the intervention.	Up to 12 months after implementation of the intervention.