Physical ActivityPhase 1NCT03548350
School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
A Phase 1 study testing HealthyKidz physical activity programme in people with Physical Activity and Health Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness and wellbeing Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behavior
- What is being tested?
- HealthyKidz physical activity programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Jun 2018
- Phase
- Phase 1
- 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 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 8-9 years
- enrolled in participating school
Who cannot join
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, BT12 6BJ
About this study
A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness and wellbeing
Read the detailed description
The experimental group will participate in a 24 week multi-component programme that includes four strands:
- A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks).
- 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week
- After schools club (not compulsory) featuring mind-set component delivered by external facilitators
- Healthy kidz app with reward system
The control group will continue doing physical activity including physical education as is normal for their school
All groups will participate in fitness assessments at week 1 and week 24 of the programme and pupils will also complete questionnaires based on measures described above at week 1 and week 24.
- Conditions
- Physical Activity, Health Behavior
- Being tested
- HealthyKidz physical activity programme
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyKidz physical activity programmeBehavioural
A 24 week physical activity intervention to promote fitness and wellbeing in primary schools
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental group will participate in a 24 week multi-component programme that includes four strands:
* A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks).
* 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week
* After schools club (not compulsory) featuring mind-set component delivered by external facilitators
* Healthy kidz app with reward system Receives: Behavioral: HealthyKidz physical activity programme |
| Control | No intervention | The control group will continue doing physical activity including physical education as is normal for their school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fitness
Change from baseline in fitness as assessed as speed and agility (20 second shuttle run), core strength (timed lying leg raise) and flexibility and balance (single standing leg raise).
Measured: Baseline and week 24
Change in health related quality of life measured by Kidscreen-10 quality of life and wellbeing in children
KIDSCREEN is a validated self-report measure of children's subjective health and well-being. Kidscreen-10 is a 10 item instrument which gives a global health related quality of life score. Scores range from 10 to 50, with higher values indicate a higher health related quality of life.
Measured: Baseline and week 24
Physical activity behaviour measured by the Physical Activity Questionnaire for Children (PAQ-C)
The Physical Activity Questionnaire for Older Children (PAQ-C) is a validated self-report questionnaire designed to assess moderate to vigorous physical activity in children over a 7 day recall. Items are scored using a 5-point scale and a mean of all 9 items is used to create an overall PAQ-C activity summary score, with higher scores indicating higher levels of physical activity.
Measured: Week 24
Secondary outcomes (4)
Enjoyment of physical activity measured using the Shortened Physical Activity Enjoyment Scale (S-PACES).
Validated scale consisting of seven negatively worded items from the PACES study. Seven items are rated on a 5-point Likert-type type scale ranging from 1 (disagree a lot) to 5 (agree a lot). Items are summed to generate the S-PACES score, and higher scores reflect greater levels of enjoyment.
Measured: Week 24
Self efficacy measured by the Modified Physical Activity Self-Efficacy Scale (PASES)
A validated 8-item measure of self-efficacy using 5 point likert scale for increased sensitivity. The mean score of all eight items is used to indicate the children's PA self-efficacy with lower scores indicating lower self-efficacy.
Measured: Week 24
Social support for physical activity measured by social support sub scale of the Social-Cognitive Measures for Physical Activity
The original scale was based on friend and family only. However, teacher social support scale was devised for the purpose of the study and follows the structure and wording of the family and friends social support for physical activity scales. Each of the 11 items is scored from 1 to 5, where a score of 1 indicates low levels of social support. Scores are summed and then averaged, resulting in a scale mean.
Measured: Week 24
Physical Self-perception measure by the Children's Physical Self-Perception Profile (CY-PSPP)
The CY-PSPP is a 36 item instrument consisting of six scales which represent a hierarchical arrangement of self-worth factors ranging from a global general self-worth scale (GSW) through a global physical self-worth scale (PSW) to four specific physical competence-adequacy sub domains. Item scores for the scale range from 1-4 with the average score being used to represent the value of the scale. Higher values indicate a better self-perception.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study startSep 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mark Tully, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548350
- Sponsor's protocol ID
- HealthyKidz
- Status last verified
- Mar 2019
- First submitted
- 14 May 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
- ClinicalTrials.gov ID
- NCT03548350
- Acronym / sponsor ID
- HealthyKidz
- Conditions
- Physical Activity, Health Behavior
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Jun 2018 (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.
A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness and wellbeing
Detailed description
The experimental group will participate in a 24 week multi-component programme that includes four strands:
- A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks).
- 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week
- After schools club (not compulsory) featuring mind-set component delivered by external facilitators
- Healthy kidz app with reward system
The control group will continue doing physical activity including physical education as is normal for their school
All groups will participate in fitness assessments at week 1 and week 24 of the programme and pupils will also complete questionnaires based on measures described above at week 1 and week 24.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HealthyKidz physical activity programmeThe experimental group will participate in a 24 week multi-component programme that includes four strands: * A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks). * 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week * After schools club (not compulsory) featuring mind-set component delivered by external facilitators * Healthy kidz app with reward system |
| Control | No intervention | –The control group will continue doing physical activity including physical education as is normal for their school |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 8-9 years
- enrolled in participating school
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
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 |
|---|---|---|
| HealthyKidz physical activity programmeA 24 week physical activity intervention to promote fitness and wellbeing in primary schools | Behavioural | Intervention |
Primary outcome
Change in fitness
Time frame: Baseline and week 24
Change from baseline in fitness as assessed as speed and agility (20 second shuttle run), core strength (timed lying leg raise) and flexibility and balance (single standing leg raise).
Change in health related quality of life measured by Kidscreen-10 quality of life and wellbeing in children
Time frame: Baseline and week 24
KIDSCREEN is a validated self-report measure of children's subjective health and well-being. Kidscreen-10 is a 10 item instrument which gives a global health related quality of life score. Scores range from 10 to 50, with higher values indicate a higher health related quality of life.
Physical activity behaviour measured by the Physical Activity Questionnaire for Children (PAQ-C)
Time frame: Week 24
The Physical Activity Questionnaire for Older Children (PAQ-C) is a validated self-report questionnaire designed to assess moderate to vigorous physical activity in children over a 7 day recall. Items are scored using a 5-point scale and a mean of all 9 items is used to create an overall PAQ-C activity summary score, with higher scores indicating higher levels of physical activity.
4 secondary outcomes
Enjoyment of physical activity measured using the Shortened Physical Activity Enjoyment Scale (S-PACES).
Time frame: Week 24
Self efficacy measured by the Modified Physical Activity Self-Efficacy Scale (PASES)
Time frame: Week 24
Social support for physical activity measured by social support sub scale of the Social-Cognitive Measures for Physical Activity
Time frame: Week 24
Physical Self-perception measure by the Children's Physical Self-Perception Profile (CY-PSPP)
Time frame: Week 24
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 29 Mar 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HealthyKidz physical activity programme in people with Physical Activity and Health Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
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 2 inclusion and 3 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 29 Mar 2019. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in fitness (time frame: Baseline and week 24). The study lists 3 primary outcomes in all. 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 29 Mar 2019.