ObesityWaistNCT01595100
Anthropometric Assessment of Abdominal Obesity and Health Risk in Children and Adolescents
An observational study of Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 423 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2011
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community sample from the Baton Rouge, Louisiana, metropolitan region
Who may be able to join
- Being between the ages of 5 and 18 years
Who cannot join
- Being unwilling or unable to communicate with study staff or provide informed consent
- Having a chronic medical condition or disease that is life threatening or would interfere with the measurements in this study
- Being pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Waist circumference, Visceral adipose tissue, Intra-abdominal fat, Pediatrics
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter T. Katzmarzyk, Pennington Biomedical Research Center
- Investigators
- Peter T Katzmarzyk, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595100
- Sponsor's protocol ID
- PBRC 29023
- Acronym
- Waist
- Status last verified
- Feb 2016
- First submitted
- 7 May 2012
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Harrington DM, Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. Waist circumference measurement site does not affect relationships with visceral adiposity and cardiometabolic risk factors in children. Pediatr Obes. 2013 Jun;8(3):199-206. doi: 10.1111/j.2047-6310.2012.00106.x. Epub 2012 Nov 21.
PubMed 23172858Broyles ST, Staiano AE, Drazba KT, Gupta AK, Sothern M, Katzmarzyk PT. Elevated C-reactive protein in children from risky neighborhoods: evidence for a stress pathway linking neighborhoods and inflammation in children. PLoS One. 2012;7(9):e45419. doi: 10.1371/journal.pone.0045419. Epub 2012 Sep 25.
PubMed 23049799Harrington DM, Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. BMI percentiles for the identification of abdominal obesity and metabolic risk in children and adolescents: evidence in support of the CDC 95th percentile. Eur J Clin Nutr. 2013 Feb;67(2):218-22. doi: 10.1038/ejcn.2012.203. Epub 2012 Dec 12.
PubMed 23232587Barreira TV, Staiano AE, Katzmarzyk PT. Validity assessment of a portable bioimpedance scale to estimate body fat percentage in white and African-American children and adolescents. Pediatr Obes. 2013 Apr;8(2):e29-32. doi: 10.1111/j.2047-6310.2012.00122.x. Epub 2012 Dec 13.
PubMed 23239610Staiano AE, Harrington DM, Broyles ST, Gupta AK, Katzmarzyk PT. Television, adiposity, and cardiometabolic risk in children and adolescents. Am J Prev Med. 2013 Jan;44(1):40-7. doi: 10.1016/j.amepre.2012.09.049.
PubMed 23253648Staiano AE, Broyles ST, Gupta AK, Malina RM, Katzmarzyk PT. Maturity-associated variation in total and depot-specific body fat in children and adolescents. Am J Hum Biol. 2013 Jul-Aug;25(4):473-9. doi: 10.1002/ajhb.22380. Epub 2013 Apr 6.
PubMed 23564417Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. Ethnic and sex differences in visceral, subcutaneous, and total body fat in children and adolescents. Obesity (Silver Spring). 2013 Jun;21(6):1251-5. doi: 10.1002/oby.20210. Epub 2013 May 13.
PubMed 23670982Staiano AE, Gupta AK, Katzmarzyk PT. Cardiometabolic risk factors and fat distribution in children and adolescents. J Pediatr. 2014 Mar;164(3):560-5. doi: 10.1016/j.jpeds.2013.10.064. Epub 2013 Dec 5.
PubMed 24315509Barreira TV, Broyles ST, Gupta AK, Katzmarzyk PT. Relationship of anthropometric indices to abdominal and total body fat in youth: sex and race differences. Obesity (Silver Spring). 2014 May;22(5):1345-50. doi: 10.1002/oby.20714. Epub 2014 Feb 19.
PubMed 24493150Katzmarzyk PT, Bouchard C. Where is the beef? Waist circumference is more highly correlated with BMI and total body fat than with abdominal visceral fat in children. Int J Obes (Lond). 2014 Jun;38(6):753-4. doi: 10.1038/ijo.2013.170. Epub 2013 Sep 10. No abstract available.
PubMed 24018751
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric Assessment of Abdominal Obesity and Health Risk in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01595100
- Acronym / sponsor ID
- Waist / PBRC 29023
- Conditions
- Obesity
- Keywords
- Waist circumference, Visceral adipose tissue, Intra-abdominal fat, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 May 2012 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community sample from the Baton Rouge, Louisiana, metropolitan region
Key inclusion criteria (1 listed)
- Being between the ages of 5 and 18 years
Key exclusion criteria (3 listed)
- Being unwilling or unable to communicate with study staff or provide informed consent
- Having a chronic medical condition or disease that is life threatening or would interfere with the measurements in this study
- Being pregnant
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 8 Feb 2016.
- Results publication: PubMed 23172858Harrington DM, Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. Waist circumference measurement site does not affect relationships with visceral adiposity and cardiometabolic risk factors in children. Pediatr Obes. 2013 Jun;8(3):199-206. doi: 10.1111/j.2047-6310.2012.00106.x. Epub 2012 Nov 21.
- Results publication: PubMed 23049799Broyles ST, Staiano AE, Drazba KT, Gupta AK, Sothern M, Katzmarzyk PT. Elevated C-reactive protein in children from risky neighborhoods: evidence for a stress pathway linking neighborhoods and inflammation in children. PLoS One. 2012;7(9):e45419. doi: 10.1371/journal.pone.0045419. Epub 2012 Sep 25.
- Results publication: PubMed 23232587Harrington DM, Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. BMI percentiles for the identification of abdominal obesity and metabolic risk in children and adolescents: evidence in support of the CDC 95th percentile. Eur J Clin Nutr. 2013 Feb;67(2):218-22. doi: 10.1038/ejcn.2012.203. Epub 2012 Dec 12.
- Results publication: PubMed 23239610Barreira TV, Staiano AE, Katzmarzyk PT. Validity assessment of a portable bioimpedance scale to estimate body fat percentage in white and African-American children and adolescents. Pediatr Obes. 2013 Apr;8(2):e29-32. doi: 10.1111/j.2047-6310.2012.00122.x. Epub 2012 Dec 13.
- Results publication: PubMed 23253648Staiano AE, Harrington DM, Broyles ST, Gupta AK, Katzmarzyk PT. Television, adiposity, and cardiometabolic risk in children and adolescents. Am J Prev Med. 2013 Jan;44(1):40-7. doi: 10.1016/j.amepre.2012.09.049.
- Results publication: PubMed 23564417Staiano AE, Broyles ST, Gupta AK, Malina RM, Katzmarzyk PT. Maturity-associated variation in total and depot-specific body fat in children and adolescents. Am J Hum Biol. 2013 Jul-Aug;25(4):473-9. doi: 10.1002/ajhb.22380. Epub 2013 Apr 6.
- Results publication: PubMed 23670982Staiano AE, Broyles ST, Gupta AK, Katzmarzyk PT. Ethnic and sex differences in visceral, subcutaneous, and total body fat in children and adolescents. Obesity (Silver Spring). 2013 Jun;21(6):1251-5. doi: 10.1002/oby.20210. Epub 2013 May 13.
- Results publication: PubMed 24315509Staiano AE, Gupta AK, Katzmarzyk PT. Cardiometabolic risk factors and fat distribution in children and adolescents. J Pediatr. 2014 Mar;164(3):560-5. doi: 10.1016/j.jpeds.2013.10.064. Epub 2013 Dec 5.
- Results publication: PubMed 24493150Barreira TV, Broyles ST, Gupta AK, Katzmarzyk PT. Relationship of anthropometric indices to abdominal and total body fat in youth: sex and race differences. Obesity (Silver Spring). 2014 May;22(5):1345-50. doi: 10.1002/oby.20714. Epub 2014 Feb 19.
- Results publication: PubMed 24018751Katzmarzyk PT, Bouchard C. Where is the beef? Waist circumference is more highly correlated with BMI and total body fat than with abdominal visceral fat in children. Int J Obes (Lond). 2014 Jun;38(6):753-4. doi: 10.1038/ijo.2013.170. Epub 2013 Sep 10. No abstract available.
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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.
Peter T Katzmarzyk, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
On the ClinicalTrials.gov record for NCT01595100, which also lists 10 linked publications.
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 8 Feb 2016.