Anthropometric Assessment of Abdominal Obesity and Health Risk in Children and Adolescents (Waist)
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| First Received Date ICMJE | May 7, 2012 | ||||
| Last Updated Date | May 8, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01595100 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anthropometric Assessment of Abdominal Obesity and Health Risk in Children and Adolescents | ||||
| Official Title ICMJE | Anthropometric Assessment of Abdominal Obesity and Health Risk in Children and Adolescents | ||||
| Brief Summary | Childhood obesity is a major public health issue, and the identification of children who are at increased risk of health problems due to their obesity is a priority for modern health care. Abdominal fat is considered to be the most harmful in the body, and the development of reliable landmarks and procedures for the assessment of intra-abdominal visceral adipose tissue and total body fat in children will have a major impact on 1) the early identification of children at elevated health risk, 2) the proper prioritization of health care resources, and 3) the standardization of obesity surveillance procedures within and between countries. |
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| Detailed Description | Abdominal fat, in particular intra-abdominal visceral adipose tissue, is considered to be the most dyslipidemic and atherogenic fat depot in the human body. Intra-abdominal visceral adipose tissue and total body fat can be measured precisely and reliably in a laboratory setting using advanced imaging techniques; however, reliable clinical measurements of pediatric intra-abdominal visceral adipose tissue and total body fat are yet to be developed. Thus, the specific aims of this study are to 1) identify reliable landmarks and methodology for the measurement of pediatric waist circumference that are associated with intra-abdominal visceral adipose tissue and total body fat across the pediatric age, total body adiposity, and maturity range among African American and Caucasian children and adolescents, 2) determine if waist circumference in combination with other anthropometric indices is a better predictor of intra-abdominal visceral adipose tissue and total body fat than waist circumference alone across the pediatric age, total body adiposity, and maturation range, and 3) develop and determine the clinical utility of pediatric race-sex-specific waist circumference thresholds for the identification of elevated chronic disease risk factors across the pediatric age, total body adiposity, and maturation range. The investigators will accomplish these aims by conducting a cross-sectional study of 100 African American boys, 100 Caucasian boys, 100 African American girls, and 100 Caucasian girls 5 to 18 years of age. Waist circumference will be measured at the four common anatomic sites used in pediatric research: 1) superior border of the iliac crest, 2) midpoint between the iliac crest and the lowest rib, 3) umbilicus, and 4) minimal waist. Additional body dimensions will be obtained in order to determine the clinical utility of combining waist circumference with other measurements in predicting intra-abdominal visceral adipose tissue and total body fat, which will be assessed using advanced imaging techniques. The identification of the most appropriate waist circumference landmarks and measurement techniques is important for the clinical identification of children at elevated obesity-related health risk and for the standardization of obesity surveillance strategies within and between countries. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Community sample from the Baton Rouge, Louisiana, metropolitan region |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 423 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01595100 | ||||
| Other Study ID Numbers ICMJE | PBRC29023 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pennington Biomedical Research Center | ||||
| Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pennington Biomedical Research Center | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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