Energy Expenditure, Diet and Body Fat in Children
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Obesity
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00024817
First Posted
September 28, 2001
Last Updated
July 14, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00024817
Brief Title
Energy Expenditure, Diet and Body Fat in Children
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Obesity
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Weber
Organizational Affiliation
Arkansas Children's Hospital Research Institute
12. IPD Sharing Statement
Learn more about this trial
Energy Expenditure, Diet and Body Fat in Children
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