Shape Up! Kids Study

Study Overview
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Brief Summary
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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.

Official Title
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Shape Up! Kids Study

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass by DXA | Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data | 1 day | 
| Lean mass by DXA | Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data | 1 day | 
| Bone mass by DXA | Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data | 1 day | 
| Fat mass by MRI | Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data | 1 day | 
| Lean mass by MRI | Measure lean mass (arms, legs, trunk, and total) using MRI data | 1 day | 
| Waist to Hip ratio (WHR) from manual tape measurement | Manual physical anthropometry of waist and hip circumferences | 1 day | 
| Automatic 3D optical (3DO) scan measurement | Automated 3DO measurement generated across the body | 1 day | 
| Hand-grip strength | Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity. | 1 day | 
| Isokinetic peak torque | Measure 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 | 1 day | 
| Isometric peak torque | Measure 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 | 1 day | 
| Fasting glucose levels | Measure fasting glucose levels | 1 day | 
| Fasting HbA1c levels | Measure fasting HbA1c levels | 1 day | 
| Fasting insulin levels | Measure fasting insulin levels | 1 day | 
| Fasting cholesterol levels | Measure fasting cholesterol levels | 1 day | 
| Fasting triglycerides levels | Measure fasting triglycerides levels | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat loss | Measure changes in fat mass during intervention using DXA data. | 24 weeks | 
| Changes in lean mass | Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data. | 24 weeks | 
| Changes in WHR | Measure changes in WHR during intervention | 24 weeks | 
| Changes in automatic 3DO scan measurement | Changes of automated 3DO measurements during intervention | 24 weeks | 
| Changes in isokinetic peak torque | Measure 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. | 24 weeks | 
| Changes in isometric peak torque | Measure 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 | 24 weeks | 
| Total Body Water | Measure total body water (L) provided by bioelectrical impedance analysis | 24 weeks | 
| Phase angle | Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis. | 24 weeks | 
| Percent body fat | Measure percent body fat provided by bioelectrical impedance analysis. | 24 weeks | 
| Body circumference from 2D imaging | A conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body circumference will be estimated using these images. | 24 weeks | 
| Systolic and Diastolic blood pressure levels will be assessed | Manually measure systolic and diastolic blood pressure levels. | 24 weeks | 
| Diet History Questionnaire II | The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions | 24 weeks |