Cardiovascular DiseaseNCT00998478
Cardiovascular Disease and the Effects of a Cross-curricular Physical Activity Intervention
A study testing Activity Knowledge Circuits in people with Cardiovascular Disease, run by University of Glamorgan at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Activity Knowledge Circuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jul 2009
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any pupil attending years 7, 8, and 9 of a secondary comprehensive school in South Wales
Who cannot join
- Any pupil with an injury or illness that prevented them from taking part in any form of physical activity.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Porth County Community School
Porth, Rhondda Cynon Taff, CF39 0BS
About this study
Official title: Cardiovascular Disease Risk Factors and the Effects of a Cross-curricular Physical Activity Intervention in 11-14 Year Olds. Activity Knowledge Circuit
The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors.
Read the detailed description
Cardiovascular disease is the leading cause of mortality worldwide. Risk factors associated with cardiovascular disease including obesity, blood pressure and blood lipids have been shown to track from childhood through to adulthood. The prevalence of overweight and obesity for children (4-18 years) in the UK is reported to be 15 % and 4 % respectively. Furthermore, in comparison to England (2.9 %) obesity is more prevalent for those living in Scotland (7.6 %) and Wales (6.5 %). Previous research from two Welsh secondary schools indicate overweight and obesity rates for boys and girls aged 12-13 to be even greater at 26 % and 38 % respectively. Further to this, 19 % were identified as having elevated total cholesterol (≥5.2 mmol/L).
For many, overweight and obesity is the result of the combined effect of excess energy consumption and inadequate physical activity. Previous school-based physical activity interventions have demonstrated modest improvements to cardiovascular disease risk factors by implementing extra-curricular activities or improving current physical education curriculum. Few have attempted to increase physical activity using normally, class-room taught curriculum subjects. This study examines the impact of activity knowledge circuits to combat cardiovascular disease risk factors in 11-14 year old children.
- Conditions
- Cardiovascular Disease
- Being tested
- Activity Knowledge Circuits
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Knowledge CircuitsOther
The activity knowledge circuits were implemented, where in addition to regular physical education (PE) activity was increased by two hours a week over an 18-week period. Participants briskly walked 3200 m twice weekly during curriculum lessons (60 min). Short tasks, in line with current curriculum, were provided by subject teachers for participants to complete at stations set every 400 or 800 m. Crucially participants continued to follow national curriculum whilst exercising. Tasks designed by teachers lasted no longer than 60 seconds at each station. With the exception of PE, each curriculum subject delivered a total of four intervention lessons. Circuits were performed outdoors on school premises, with an indoor course of equal distance used during adverse weather conditions.
| Study group | Role | What they receive |
|---|---|---|
| Activity prescription | Experimental | Not described Receives: Other: Activity Knowledge Circuits |
| Normal Curriculum | No intervention | Followed normal curriculum including physical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein)
Measured: 6 Months
Secondary outcomes (5)
Physical activity behaviour and aerobic fitness profile
Measured: 6 Months
7 day diet assessment
Measured: 6 Months
Maturation status
Measured: 6 Months
Motivation to exercise
Measured: 6 Months
Psychological well-being, self concept, and cognitive performance
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glamorgan
- Sponsor type
- University, hospital or other
- Collaborators
- Sports Council Wales, University of Wales Institute Cardiff
- Investigators
- Gareth J Knox, MSc, Principal investigator, University of Wales Institute Cardiff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998478
- Sponsor's protocol ID
- AKC01
- Status last verified
- Oct 2009
- First submitted
- 19 Oct 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
Publications
Knox G, Baker JS, Davies B, Faulkner S, Rance J, Rees A, Morgan K, Thomas N. A cross-curricular physical activity intervention to combat cardiovascular disease risk factors in 11-14 year olds: 'activity knowledge circuit'. BMC Public Health. 2009 Dec 15;9:466. doi: 10.1186/1471-2458-9-466.
PubMed 20003492
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease Risk Factors and the Effects of a Cross-curricular Physical Activity Intervention in 11-14 Year Olds. Activity Knowledge Circuit
- ClinicalTrials.gov ID
- NCT00998478
- Acronym / sponsor ID
- AKC01
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of GlamorganUniversity, hospital or other
- Collaborators
- Sports Council Wales, University of Wales Institute Cardiff
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Oct 2009 (estimated)
- 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.
The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors.
Detailed description
Cardiovascular disease is the leading cause of mortality worldwide. Risk factors associated with cardiovascular disease including obesity, blood pressure and blood lipids have been shown to track from childhood through to adulthood. The prevalence of overweight and obesity for children (4-18 years) in the UK is reported to be 15 % and 4 % respectively. Furthermore, in comparison to England (2.9 %) obesity is more prevalent for those living in Scotland (7.6 %) and Wales (6.5 %). Previous research from two Welsh secondary schools indicate overweight and obesity rates for boys and girls aged 12-13 to be even greater at 26 % and 38 % respectively. Further to this, 19 % were identified as having elevated total cholesterol (≥5.2 mmol/L).
For many, overweight and obesity is the result of the combined effect of excess energy consumption and inadequate physical activity. Previous school-based physical activity interventions have demonstrated modest improvements to cardiovascular disease risk factors by implementing extra-curricular activities or improving current physical education curriculum. Few have attempted to increase physical activity using normally, class-room taught curriculum subjects. This study examines the impact of activity knowledge circuits to combat cardiovascular disease risk factors in 11-14 year old children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity prescription | Experimental | Other: Activity Knowledge Circuits |
| Normal Curriculum | No intervention | –Followed normal curriculum including physical education |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any pupil attending years 7, 8, and 9 of a secondary comprehensive school in South Wales
Key exclusion criteria (1 listed)
- Any pupil with an injury or illness that prevented them from taking part in any form of physical activity.
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 |
|---|---|---|
| Activity Knowledge CircuitsThe activity knowledge circuits were implemented, where in addition to regular physical education (PE) activity was increased by two hours a week over an 18-week period. Participants briskly walked 3200 m twice weekly during curriculum lessons (60 min). Short tasks, in line with current curriculum, were provided by subject teachers for participants to complete at stations set every 400 or 800 m. Crucially participants continued to follow national curriculum whilst exercising. Tasks designed by teachers lasted no longer than 60 seconds at each station. With the exception of PE, each curriculum subject delivered a total of four intervention lessons. Circuits were performed outdoors on school premises, with an indoor course of equal distance used during adverse weather conditions. | Other | Activity prescription |
Primary outcome
Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein)
Time frame: 6 Months
5 secondary outcomes
Physical activity behaviour and aerobic fitness profile
Time frame: 6 Months
7 day diet assessment
Time frame: 6 Months
Maturation status
Time frame: 6 Months
Motivation to exercise
Time frame: 6 Months
Psychological well-being, self concept, and cognitive performance
Time frame: 6 Months
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 20 Oct 2009.
- Derived from this study: PubMed 20003492Knox G, Baker JS, Davies B, Faulkner S, Rance J, Rees A, Morgan K, Thomas N. A cross-curricular physical activity intervention to combat cardiovascular disease risk factors in 11-14 year olds: 'activity knowledge circuit'. BMC Public Health. 2009 Dec 15;9:466. doi: 10.1186/1471-2458-9-466.
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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.
Gareth J Knox, MSc principal investigator
University of Wales Institute Cardiff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Knowledge Circuits in people with Cardiovascular Disease, run by University of Glamorgan 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 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: finished, as of the sponsor's last update on 20 Oct 2009. 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.
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?
Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00998478, which also lists 1 linked publication.
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 20 Oct 2009.