- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03135223
Participatory Research to Promote Physical Activity
Development of Intervention Strategies to Increase Physical Activity and Reduce Sedentary Behaviour in Secondary Schoolgirls by Means of Participatory Health Research
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
Co-created, school-based intervention to promote physical activity
|
A working group of girls and researcher co-created a school-specific intervention to promote physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one schoolyear
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one schoolyear
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FWO13/PDO/191
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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