Cardiovascular RiskPhase 4ALLChangeNCT01005186
Changing Lifestyle in Children
A Phase 4 study testing Eating habits, diet and exercise in people with Cardiovascular Risk, run by University of Dundee.
Trial summary
A lifestyle intervention aimed at improving exercise levels in primary school children. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- Eating habits, diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 4
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 9-11 yrs
Who cannot join
- Children <9 yrs and >12 yrs
About this study
Official title: Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?
A lifestyle intervention aimed at improving exercise levels in primary school children.
- Conditions
- Cardiovascular Risk
- Being tested
- Eating habits, diet and exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating habits, diet and exerciseBehavioural
Programme of change to eating habits, diet and exercise
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active Receives: Behavioral: Eating habits, diet and exercise |
| Active 2 | Experimental | Active Receives: Behavioral: Eating habits, diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?
Secondary outcomes (1)
Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- University of St Andrews
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005186
- Sponsor's protocol ID
- 2003CV40
- Acronym
- ALLChange
- Status last verified
- Jan 2016
- First submitted
- 29 Oct 2009
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?
- ClinicalTrials.gov ID
- NCT01005186
- Acronym / sponsor ID
- ALLChange / 2003CV40
- Conditions
- Cardiovascular Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- University of St Andrews
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 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.
A lifestyle intervention aimed at improving exercise levels in primary school children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Eating habits, diet and exerciseActive |
| Active 2 | Experimental | Behavioral: Eating habits, diet and exerciseActive |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 9-11 yrs
Key exclusion criteria (1 listed)
- Children <9 yrs and >12 yrs
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 |
|---|---|---|
| Eating habits, diet and exerciseProgramme of change to eating habits, diet and exercise | Behavioural | Active, Active 2 |
Primary outcome
Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?
1 secondary outcome
Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?
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 8 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eating habits, diet and exercise in people with Cardiovascular Risk, run by University of Dundee.
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 8 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?. 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 8 Jan 2016.