Cardiovascular DiseasesNCT00024817
Energy Expenditure, Diet and Body Fat in Children
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2002
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2001 (estimated)
- Study startSep 1999
- Study completionAug 2002
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.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Judith Weber, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024817
- Sponsor's protocol ID
- 986
- Other IDs
- R01HL065053
- Status last verified
- Aug 2004
- First submitted
- 28 Sep 2001
- Last updated
- 15 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure, Diet and Body Fat in Children
- ClinicalTrials.gov ID
- NCT00024817
- Acronym / sponsor ID
- 986
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Sep 2001 (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 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.
Study design
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 15 Jul 2016.
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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.
Judith Weber
Arkansas Children's Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 15 Jul 2016. 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 15 Jul 2016.