Soft Tissue and Bone Development in Young Girls
STAR
Obesity and Bone Development in Young Girls
1 other identifier
observational
450
1 country
1
Brief Summary
Obesity during adolescence, a critical time for bone development, may impair mineral accrual and reduce bone strength, leading to greater fracture risk during adolescence and later in life. This study seeks to determine the effect of obesity and accompanying metabolic changes (insulin resistance and inflammation) on bone mineral accrual and related changes in structure and strength in young girls. The information is critical to developing effective prevention strategies to counter the linked risks of obesity and osteoporosis, both major public health concerns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 26, 2016
September 1, 2016
4.9 years
January 11, 2016
September 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Bone development
Baseline cross-sectional (N=450) and longitudinal changes over 2 years (N=150) in bone mass, density, structure and strength, measured by peripheral quantitative computed tomography (pQCT) and dual-energy X-ray absorptiometry (DXA), as they relate to body composition by DXA and blood biomarkers of insulin resistance and inflammation.
2 years
Eligibility Criteria
Girls across obese (n=150; BMI ≥95th age and gender-specific percentile), overweight (n=150; BMI\> 85th percentile and \<95th percentile), and normal weight (n=150; BMI\< 85th percentile) categories.
You may qualify if:
- healthy, female, aged 9-12 years
You may not qualify if:
- diagnosis of diabetes
- taking medications that alter body composition and bone mineral accrual
- physical disability that limits physical activity
- learning disability that would limit completion of questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona, Nutritional Sciences Department
Tucson, Arizona, 85714, United States
Related Publications (1)
Hetherington-Rauth M, Bea JW, Lee VR, Blew RM, Funk J, Lohman TG, Going SB. Comparison of direct measures of adiposity with indirect measures for assessing cardiometabolic risk factors in preadolescent girls. Nutr J. 2017 Feb 23;16(1):15. doi: 10.1186/s12937-017-0236-7.
PMID: 28231807DERIVED
Biospecimen
serum, saliva
Study Officials
- PRINCIPAL INVESTIGATOR
Scott B Going, PhD
University of Arizona
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 13, 2016
Study Start
January 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
September 26, 2016
Record last verified: 2016-09