Physical InactivityPULSENCT06156553
School-based Intervention to Support Active Travel
A study testing PULSE school-based intervention in people with Physical Inactivity and Health Literacy, run by Nordic Institute for Studies of Innovation, Research and Education at 1 site in Norway.
Trial summary
"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Health Literacy
- What is being tested?
- PULSE school-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Student in 9. grade at the 4 intervention schools
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
NIFU Nordic Institute for Studies of innovation, research and education
Oslo, 0608
Cay Gjerustad, PhD, 93638313 ext. 0047, cay.gjerustad@nifu.no
About this study
Official title: School-based Intervention to Support Active Travel. This Study is Part of the Research Project "ULSE - Promoting Active School Travel to Improve Mood and Performance".
"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. The first session will be delivered by a science and education center, and the consecutive sessions will be delivered by teachers. PULSE sessions will contribute to the attainment of specific competence aims related to two interdisciplinary topics, "Health and life skills" and "Sustainability", as defined in PE, social science, and science. The research question is the following: Can increased attention to the barriers and benefits of active travel increase physical activity for youths?
Read the detailed description
Previous reviews and meta-analyses of school-based active travel interventions have found educational strategies to be the most effective. However, previous intervention studies are heterogeneous, and the majority demonstrate poor intervention quality and a lack of description of the interventions. The present study has developed a theory-based educational intervention designed to increase knowledge and empower behavioral change. To ensure local relevance, quality, effectiveness, and sustainability, the intervention has been developed by means of a co-creation process during five collaborative workshops. Participants were a combination of researchers, educators from the science center, representative of the municipality initiative Global Active City in addition to representatives of the teachers from the schools which are to implement the intervention. The intervention is designed to support learning, self-regulation, and autonomous motivation for sustained behavioral change. The theoretical framework is guided by the Self-determination theory developed by Deci and Ryan. The learning activities are predominantly student active and often group-based, introduced by short videos and teacher instructions. The intervention is designed to support three basic psychological needs that, according to the Self-determination theory, are pivotal for motivation and behavioral change: (1) students' need for autonomy and agency related to active travel, (2) their need for relatedness and social support in their efforts to make lifestyle changes when faced with personal, social, and structural barriers, and (3) their need for mastery and competence.
The following data will be collected:
- Questionnaire to students, pre and post
- Document of implementation and adoption completed by teachers
- Group interviews with students who participate in the intervention
- Interviews with teachers who deliver the interviews
- Conditions
- Physical Inactivity, Health Literacy
- Being tested
- PULSE school-based intervention
- Keywords
- Active travel, Curriculum-based school intervention, Feasibility study
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULSE school-based interventionBehavioural
"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. The first session will be delivered by a science and education center, and the consecutive sessions will be delivered by teachers. PULSE sessions will contribute to the attainment of specific competence aims related to two interdisciplinary topics, "Health and life skills" and "Sustainability", as defined in PE, social science, and science. The research question is the following: Can increased attention to the barriers and benefits of active travel increase physical activity for youths?
| Study group | Role | What they receive |
|---|---|---|
| Students in 9. grade participating in a school-based intervention | Experimental | Students from 9. grade at 4 schools in a Norwegian municipality. The students will take part in a school and curriculum based intervention delivered by a combination of educators from a science center (1 session) and teachers (5 sessions) Receives: Behavioral: PULSE school-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active travel habits
Number of days per week where students walk or use bicycle to/from school or during leisure time activities
Measured: 8-10 weeks
Secondary outcomes (2)
Health literacy
Knowledge about the health benefits of active travel, and where needed information about active travel can be found
Measured: 8-10 weeks
Autonomous motivation for active travel
The students identify with the health, well-being and sustainability benefits of active travel or enjoy their active travels
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Institute for Studies of Innovation, Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Transport Economics, Norway, University of Agder, Fredrikstad municipality, Norway, INSPIRIA Science Center, Norway
- Responsible party
- Principal investigator, Cathrine Pedersen, Nordic Institute for Studies of Innovation, Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156553
- Sponsor's protocol ID
- 21364
- Acronym
- PULSE
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Intervention to Support Active Travel. This Study is Part of the Research Project "ULSE - Promoting Active School Travel to Improve Mood and Performance".
- ClinicalTrials.gov ID
- NCT06156553
- Acronym / sponsor ID
- PULSE / 21364
- Conditions
- Physical Inactivity, Health Literacy
- Keywords
- Active travel, Curriculum-based school intervention, Feasibility study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nordic Institute for Studies of Innovation, Research and EducationUniversity, hospital or other
- Collaborators
- The Institute of Transport Economics, Norway, University of Agder, Fredrikstad municipality, Norway, INSPIRIA Science Center, Norway
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Dec 2023 (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.
"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. The first session will be delivered by a science and education center, and the consecutive sessions will be delivered by teachers. PULSE sessions will contribute to the attainment of specific competence aims related to two interdisciplinary topics, "Health and life skills" and "Sustainability", as defined in PE, social science, and science. The research question is the following: Can increased attention to the barriers and benefits of active travel increase physical activity for youths?
Detailed description
Previous reviews and meta-analyses of school-based active travel interventions have found educational strategies to be the most effective. However, previous intervention studies are heterogeneous, and the majority demonstrate poor intervention quality and a lack of description of the interventions. The present study has developed a theory-based educational intervention designed to increase knowledge and empower behavioral change. To ensure local relevance, quality, effectiveness, and sustainability, the intervention has been developed by means of a co-creation process during five collaborative workshops. Participants were a combination of researchers, educators from the science center, representative of the municipality initiative Global Active City in addition to representatives of the teachers from the schools which are to implement the intervention. The intervention is designed to support learning, self-regulation, and autonomous motivation for sustained behavioral change. The theoretical framework is guided by the Self-determination theory developed by Deci and Ryan. The learning activities are predominantly student active and often group-based, introduced by short videos and teacher instructions. The intervention is designed to support three basic psychological needs that, according to the Self-determination theory, are pivotal for motivation and behavioral change: (1) students' need for autonomy and agency related to active travel, (2) their need for relatedness and social support in their efforts to make lifestyle changes when faced with personal, social, and structural barriers, and (3) their need for mastery and competence.
The following data will be collected:
- Questionnaire to students, pre and post
- Document of implementation and adoption completed by teachers
- Group interviews with students who participate in the intervention
- Interviews with teachers who deliver the interviews
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students in 9. grade participating in a school-based intervention | Experimental | Behavioral: PULSE school-based interventionStudents from 9. grade at 4 schools in a Norwegian municipality. The students will take part in a school and curriculum based intervention delivered by a combination of educators from a science center (1 session) and teachers (5 sessions) |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Student in 9. grade at the 4 intervention schools
Key exclusion criteria (1 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 |
|---|---|---|
| PULSE school-based intervention"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. The first session will be delivered by a science and education center, and the consecutive sessions will be delivered by teachers. PULSE sessions will contribute to the attainment of specific competence aims related to two interdisciplinary topics, "Health and life skills" and "Sustainability", as defined in PE, social science, and science. The research question is the following: Can increased attention to the barriers and benefits of active travel increase physical activity for youths? | Behavioural | Students in 9. grade participating in a school-based intervention |
Primary outcome
Active travel habits
Time frame: 8-10 weeks
Number of days per week where students walk or use bicycle to/from school or during leisure time activities
2 secondary outcomes
Health literacy
Time frame: 8-10 weeks
Autonomous motivation for active travel
Time frame: 8-10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Research project websiteLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PULSE school-based intervention in people with Physical Inactivity and Health Literacy, run by Nordic Institute for Studies of Innovation, Research and Education at 1 site in Norway.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathrine N Pedersen, PhD (95280687 ext. 0047, cathrine.pedersen@nifu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active travel habits (time frame: 8-10 weeks). 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 5 Dec 2023.