Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00024817 |
| Other study ID # |
986 |
| Secondary ID |
R01HL065053 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 28, 2001 |
| Last updated |
July 14, 2016 |
| Start date |
September 1999 |
| Est. completion date |
August 2002 |
Study information
| Verified date |
August 2004 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To characterize the pattern of change over a two year period in energy expenditure and
energy intake in two cohorts of American Indian (AI) children.
Description:
BACKGROUND:
Obesity is highly prevalent in American Indian children, increasing their risk for the
development of cardiovascular disease, hypertension and diabetes. Although increasing energy
expenditure, through increasing physical activity, and decreasing dietary fat intake should
slow the rate of body fat gain, it appears that children actually decrease their physical
activity as they mature from pre-to post-pubescence. Several studies have shown that the
decline in activity is greater in females than in males, and greater in non-whites than in
whites; however, other studies have not supported these findings. Further, there were no
data available in American Indian children, which is a population at greatest risk.
Additionally, inconsistencies have been reported with respect to the relationship between
body weight or body fat and energy intake or dietary fat intake. At the heart of the problem
is the difficulty in measuring self-reported physical activity and dietary intake
accurately. Accurate self- report measures are necessary for use in the large scale studies
that are required to investigate relationships between physical activity and dietary intake
and disease. The Healthy People 2000: National Health Promotion and Disease Prevention
Objectives include seven objectives emphasizing increasing physical activity in children and
adolescents.
DESIGN NARRATIVE:
This study had a combined longitudinal and cross-sectional design in which the investigators
modified the best existing methods for the self-report of physical activity and dietary
intake in children and adolescents, and evaluated their validity using total energy
expenditure (TEE) measured by doubly labeled water (DLW) as the criterion. They then used
these methods to measure physical activity and dietary intake in two age cohorts of male and
female American Indian children (8-10-years and 11-13-years) at baseline and two years
later, with two sets of interim measurements. Change in TEE from baseline to the two-year
follow-up was also measured using DLW and the TriTrac accelerometer. Equations for the
estimation of percent body fat were cross-validated for this population. The study filled an
existing gap by improving existing instruments for the measurement of physical activity and
dietary intake in children and adolescents, and provided longitudinal data on change in
these variables in the same children over time, plus provided cross-sectional data for each
age and gender group to compare to the existing literature.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
