Risk ReductionCETICARPNCT01416545
Children Education and Cardiovascular Risk Reduction in Their Parents
A study testing Educational program in cardiovascular prevention and Lifestyle counseling in people with Risk Reduction, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Educational program in cardiovascular prevention and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jun 2011
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil
Who cannot join
- children and/or parents that do not agree to participate of the study;
- children and/or parents that are taking immunosupressive drugs;
- parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
- parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
InCor (Heart Institute) - Hospital das Clinicas da FMUSP
São Paulo, 05403-900
About this study
Official title: Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents
This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.
Read the detailed description
Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
- Conditions
- Risk Reduction
- Being tested
- Educational program in cardiovascular prevention, Lifestyle counseling
- Keywords
- Primary Prevention, Cardiovascular disease, Child, Behavior modification, Activities, Educational
- Medical subject headings
- Risk Reduction Behavior, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program in cardiovascular preventionBehavioural
a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
Lifestyle counselingBehavioural
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention. Receives: Behavioral: Educational program in cardiovascular prevention |
| Control group | Placebo comparator | The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting). Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
Measured: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Bruno Caramelli, University of Sao Paulo
- Investigators
- Bruno Caramelli, MD, PhD, Study chair, University of Sao PauloLuciana S Fornari, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416545
- Sponsor's protocol ID
- 2009/17450-3
- Other IDs
- 2009
- Acronym
- CETICARP
- Status last verified
- Mar 2019
- First submitted
- 11 Aug 2011
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents
- ClinicalTrials.gov ID
- NCT01416545
- Acronym / sponsor ID
- CETICARP / 2009/17450-3
- Conditions
- Risk Reduction
- Keywords
- Primary Prevention, Cardiovascular disease, Child, Behavior modification, Activities, Educational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Aug 2011 (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.
This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.
Detailed description
Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Educational program in cardiovascular preventionChildren received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention. |
| Control group | Placebo comparator | Behavioral: Lifestyle counselingThe control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting). |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil
Key exclusion criteria (4 listed)
- children and/or parents that do not agree to participate of the study;
- children and/or parents that are taking immunosupressive drugs;
- parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
- parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.
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 |
|---|---|---|
| Educational program in cardiovascular preventiona weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams. | Behavioural | Lifestyle counseling |
| Lifestyle counselingThe control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting). | Behavioural | Control group |
Primary outcome
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
Time frame: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.
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 26 Mar 2019.
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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.
Bruno Caramelli, MD, PhD study chair
University of Sao Paulo
Luciana S Fornari, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in cardiovascular prevention and Lifestyle counseling in people with Risk Reduction, run by University of Sao Paulo at 1 site in Brazil.
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 4 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 26 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases. (time frame: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.). 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 26 Mar 2019.