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Shape Up! Kids Study

Shape Up! Kids Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03706612
Enrollment
430
Registered
2018-10-16
Start date
2017-04-01
Completion date
2023-01-04
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Identify the unique associations of body shape to body composition and bone density indices in a pediatric population that represents the variance of sex, age, BMI-Z, and ethnicity found in the US population. Describe the precision and accuracy of optical scans to monitor change in body composition, bone density and metabolic health interventions. Estimate the level of association of optical to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI-Z. Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of body composition and metabolic risk using statistical shape models and Latent Class Analysis.

Interventions

None listed

Sponsors

University of California, San Francisco
CollaboratorOTHER
Pennington Biomedical Research Center
CollaboratorOTHER
University of Hawaii
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy participants will be included in the study if they have a self-reported ability to: * walk one-quarter of a mile and climb 10 steps without difficulty, * perform activities of daily living (ADLs) without difficulty, and * have no life-threatening conditions or diseases that would alter body composition from what is typical for age, sex, ethnicity, and BMI.

Exclusion criteria

* any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment * Pregnant or breastfeeding. (All premenopausal females will be asked for a spot urine sample for pregnancy test prior to participation. Those unwilling to comply with this will not be included.

Design outcomes

Primary

MeasureTime frameDescription
Fasting triglycerides levels1 dayMeasure fasting triglycerides levels
Bone mass by DXA1 dayMeasure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Fat mass by MRI1 dayMeasure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
Lean mass by MRI1 dayMeasure lean mass (arms, legs, trunk, and total) using MRI data
Waist to Hip ratio (WHR) from manual tape measurement1 dayManual physical anthropometry of waist and hip circumferences
Automatic 3D optical (3DO) scan measurement1 dayAutomated 3DO measurement generated across the body
Hand-grip strength1 dayMeasured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
Isokinetic peak torque1 dayMeasure the peak torque value (FT-LBS) generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Isometric peak torque1 dayMeasure the peak torque value (FT-LBS) generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Fasting glucose levels1 dayMeasure fasting glucose levels
Fasting HbA1c levels1 dayMeasure fasting HbA1c levels
Fasting insulin levels1 dayMeasure fasting insulin levels
Fasting cholesterol levels1 dayMeasure fasting cholesterol levels
Fat mass by DXA1 dayMeasure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Lean mass by DXA1 dayMeasure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

Secondary

MeasureTime frameDescription
Fat loss24 weeksMeasure changes in fat mass during intervention using DXA data.
Changes in lean mass24 weeksMeasure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data.
Changes in WHR24 weeksMeasure changes in WHR during intervention
Changes in automatic 3DO scan measurement24 weeksChanges of automated 3DO measurements during intervention
Changes in isokinetic peak torque24 weeksMeasure the change in peak torque value generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention.
Changes in isometric peak torque24 weeksMeasure the change in peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention
Total Body Water24 weeksMeasure total body water (L) provided by bioelectrical impedance analysis
Phase angle24 weeksPhase angle \[PhA(°) = (reactance/electrical resistance) × (180°/Π)\] will be measured in degrees using bioelectrical impedance analysis.
Percent body fat24 weeksMeasure percent body fat provided by bioelectrical impedance analysis.
Body circumference from 2D imaging24 weeksA conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body circumference will be estimated using these images.
Diet History Questionnaire II24 weeksThe Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions
Systolic and Diastolic blood pressure levels will be assessed24 weeksManually measure systolic and diastolic blood pressure levels.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026