Cardiovascular DiseasesNCT00005416
Diet, Exercise, and Cardiovascular Health Among Ethnic Children
An observational study of Cardiovascular Diseases and Heart Diseases, run by Augusta University.
Trial summary
To analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in Galveston, Texas, and in Augusta, GA, in regard to cardiovascular disease (CVD) physical risk factors and risk related behaviors. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1992to Jun 1995
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in Galveston, Texas, and in Augusta, GA, in regard to cardiovascular disease (CVD) physical risk factors and risk related behaviors.
Read the detailed description
BACKGROUND:
Little was known about tracking of cardiovascular disease (CVD) risk factors and risk related behaviors, or about predicting these variables in young children. Tracking was an important issue because it reflected the extent to which the disease processes found among adults start in childhood, and whether behavioral or social factors could be used to interrupt that tracking.
DESIGN NARRATIVE:
In Texas, physical risk factor data were collected at four annual clinics. Data on childrens' physical activity and diet were collected for up to four times per year for the three years between the annual measurement clinics. Similar data, although with some different measurement techniques, were collected in Georgia. For this data analysis, specific longitudinal research questions addressed whether these physical risk factors (blood pressure, lipids, lipoproteins and body composition) and risk related behaviors (diet and physical activity) tracked across the annual assessments, whether a variety of behavioral and social factors (demographic characteristics and family function) affected that tracking, and whether relationships obtained among adults between physical risk factors and these other variables could be found in this age child. The testing of these relationships was enhanced by the availability of multiple assessments of blood pressures and body composition at each point for more reliable assessments, and by multiple assessments of diet and physical activity within each year. It was further enhanced by the availability of observational data on physical activity and diet, which overcame the limitations of the more common self report approach to measurement. Models were developed in each data set and cross validated in the other. Procedures were employed to determine reasons for differences and to revise the models to produce maximal fit in both data sets. The results of these analyses contributed to a better understanding of at what age, and with what factors, it was most appropriate to intervene to mitigate CVD.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1992
- Study completionJun 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005416
- Sponsor's protocol ID
- 4334
- Other IDs
- R03HL047534
- Status last verified
- Apr 2002
- First submitted
- 25 May 2000
- Last updated
- 23 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Exercise, and Cardiovascular Health Among Ethnic Children
- ClinicalTrials.gov ID
- NCT00005416
- Acronym / sponsor ID
- 4334
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1992
- Study completion
- Jun 1995
- First posted
- 26 May 2000 (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.
To analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in Galveston, Texas, and in Augusta, GA, in regard to cardiovascular disease (CVD) physical risk factors and risk related behaviors.
Detailed description
BACKGROUND:
Little was known about tracking of cardiovascular disease (CVD) risk factors and risk related behaviors, or about predicting these variables in young children. Tracking was an important issue because it reflected the extent to which the disease processes found among adults start in childhood, and whether behavioral or social factors could be used to interrupt that tracking.
DESIGN NARRATIVE:
In Texas, physical risk factor data were collected at four annual clinics. Data on childrens' physical activity and diet were collected for up to four times per year for the three years between the annual measurement clinics. Similar data, although with some different measurement techniques, were collected in Georgia. For this data analysis, specific longitudinal research questions addressed whether these physical risk factors (blood pressure, lipids, lipoproteins and body composition) and risk related behaviors (diet and physical activity) tracked across the annual assessments, whether a variety of behavioral and social factors (demographic characteristics and family function) affected that tracking, and whether relationships obtained among adults between physical risk factors and these other variables could be found in this age child. The testing of these relationships was enhanced by the availability of multiple assessments of blood pressures and body composition at each point for more reliable assessments, and by multiple assessments of diet and physical activity within each year. It was further enhanced by the availability of observational data on physical activity and diet, which overcame the limitations of the more common self report approach to measurement. Models were developed in each data set and cross validated in the other. Procedures were employed to determine reasons for differences and to revise the models to produce maximal fit in both data sets. The results of these analyses contributed to a better understanding of at what age, and with what factors, it was most appropriate to intervene to mitigate CVD.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Dec 2015.
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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?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Dec 2015. 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.
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.
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 23 Dec 2015.