Children Education and Cardiovascular Risk Reduction in Their Parents (CETICARP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Risk Reduction |
Behavioral: Educational program in cardiovascular prevention Behavioral: Lifestyle counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents |
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 520 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lifestyle counseling
Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention.
|
Behavioral: Educational program in cardiovascular prevention
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.
|
|
Placebo Comparator: Control group
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
|
Behavioral: Lifestyle counseling
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil
Exclusion Criteria:
- 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.
Contacts and Locations| Brazil | |
| InCor (Heart Institute) - Hospital das Clinicas da FMUSP | |
| Sao Paulo, Brazil, 05403-900 | |
| Study Chair: | Bruno Caramelli, MD, PhD | University of Sao Paulo |
| Principal Investigator: | Luciana S Fornari, MD, PhD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Bruno Caramelli, MD,PhD, Heart Institute, University of Sao Paulo Medical School |
| ClinicalTrials.gov Identifier: | NCT01416545 History of Changes |
| Other Study ID Numbers: | 2009/17450-3 |
| Study First Received: | August 11, 2011 |
| Last Updated: | August 12, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Primary Prevention Cardiovascular disease Child Behavior modification Activities, Educational |
ClinicalTrials.gov processed this record on May 23, 2013