Health BehaviorNCT03135223
Participatory Research to Promote Physical Activity
A study testing Co-created intervention to promote physical activity in people with Health Behavior, run by University Ghent.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Co-created intervention to promote physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Health Behavior
- Being tested
- Co-created intervention to promote physical activity
- Keywords
- Physical activity
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-created intervention to promote physical activityBehavioural
A working group of girls and researcher co-created a school-specific intervention to promote physical activity
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Co-created, school-based intervention to promote physical activity Receives: Behavioral: Co-created intervention to promote physical activity |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one schoolyear
Secondary outcomes (1)
Increase in the mean value of determinants related to physical activity
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.
Measured: one schoolyear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Sep 2014
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One intervention and one control condition
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vakgroepsport, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135223
- Sponsor's protocol ID
- FWO13/PDO/191
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Intervention Strategies to Increase Physical Activity and Reduce Sedentary Behaviour in Secondary Schoolgirls by Means of Participatory Health Research
- ClinicalTrials.gov ID
- NCT03135223
- Acronym / sponsor ID
- FWO13/PDO/191
- Conditions
- Health Behavior
- Keywords
- Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One intervention and one control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Co-created intervention to promote physical activityCo-created, school-based intervention to promote physical activity |
| Control group | No intervention | – |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-created intervention to promote physical activityA working group of girls and researcher co-created a school-specific intervention to promote physical activity | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Increase in the mean value of determinants related to physical activity
Time frame: one schoolyear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
Related trials for Health Behavior
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Co-created intervention to promote physical activity in people with Health Behavior, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the mean overall physical activity level of adolescent girls (time frame: one schoolyear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.