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Completed

NCT Number: NCT03135223

Participatory Research to Promote Physical Activity

Secondary schoolgirls have the most unhealthy profile regarding physical activity and sedentary behaviour of all age groups. Since both behaviours independently contribute to various health outcomes, an effective intervention to promote physical activity and to reduce sedentary behaviour needs to be developed.

Many interventions fail to induce changes in health behaviour, as they often use a top-down approach with limited input from the end-users (i.e. the secondary schoolgirls) of the intervention programmes. This project uses a participatory health research approach by actively involving the girls in the entire research process. A co-creation group was set up per intervention school (n=3), including girls and a researcher which co-created a school-specific intervention, tailored to the needs and interests of those girls.

The effect of participatory process were evaluated via a clustered randomized controlled trial using an intervention and control condition and a pre- and post-test design. Effects on physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were evaluated. The hypothesis was that girls from the intervention condition would improve their physical activity levels and related determinants compared to no changes among girls from the control schools. The process was evaluated as well using focus group research and the hypothesis was that girls who participate in the co-creation groups would be positive about the process and will feel empowered.

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Key information

Age range

15 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study

Treatment and study plan

Co-created intervention to promote physical activity

Behavioral

A working group of girls and researcher co-created a school-specific intervention to promote physical activity

Primary outcomes

  1. Increase in the mean overall physical activity level of adolescent girls

    Time frame: one schoolyear

    Overall physical activity (expressed in average minutes per day) is calculated by summing active transportation (i.e. minutes spent in active transportation to school and in leisure time per day) and sport participation (i.e. minutes spent in physical education, extra-curricular sports or physical activities at school and during leisure time per day), measured by the reliable and valid Flemish Physical Activity Questionnaire.

Secondary outcomes

  1. Increase in the mean value of determinants related to physical activity

    Time frame: one schoolyear

    Three individual (i.e. self-efficacy, perceived benefits and perceived barriers) and six sociocultural determinants (i.e. peer and parental modelling, peer and parental co-participation and peer and parental encouragement) were assessed using questions from previous studies examining adolescents' health behaviour, of which the predictive validity and reliability have been demonstrated previously. Three school-related determinants (i.e. relationship with classmates, involvement in organising school activities and relationship with teachers) were assessed using items from the Flemish Health Behaviour in School-aged Children questionnaire.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Development of Intervention Strategies to Increase Physical Activity and Reduce Sedentary Behaviour in Secondary Schoolgirls by Means of Participatory Health Research

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 1, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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