Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005416 |
| Other study ID # |
4334 |
| Secondary ID |
R03HL047534 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
December 21, 2015 |
| Start date |
July 1992 |
| Est. completion date |
June 1995 |
Study information
| Verified date |
April 2002 |
| Source |
Georgia Regents University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical 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.
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.
