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Cardiovascular DiseasesNCT00005416

Diet, Exercise, and Cardiovascular Health Among Ethnic Children

An observational study of Cardiovascular Diseases and Heart Diseases, run by Augusta University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. First posted26 May 2000 (estimated)
  2. Study startJul 1992
  3. Study completionJun 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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

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.

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