NCT03135223

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

April 18, 2017

Last Update Submit

April 25, 2017

Conditions

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

  • Increase in the mean overall physical activity level of adolescent girls

    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 Outcomes (1)

  • Increase in the mean value of determinants related to physical activity

    one schoolyear

Study Arms (2)

Intervention group

EXPERIMENTAL

Co-created, school-based intervention to promote physical activity

Behavioral: Co-created intervention to promote physical activity

Control group

NO INTERVENTION

Interventions

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

Intervention group

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One intervention and one control condition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Greet Cardon

Study Record Dates

First Submitted

April 18, 2017

First Posted

May 1, 2017

Study Start

September 1, 2014

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

May 1, 2017

Record last verified: 2017-04