Shape Up! Kids Study
- Conditions
- Healthy
- Registration Number
- NCT03706612
- Lead Sponsor
- University of Hawaii
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 430
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat mass by DXA 1 day Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Bone mass by DXA 1 day Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Automatic 3D optical (3DO) scan measurement 1 day Automated 3DO measurement generated across the body
Fat mass by MRI 1 day Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
Lean mass by MRI 1 day Measure lean mass (arms, legs, trunk, and total) using MRI data
Waist to Hip ratio (WHR) from manual tape measurement 1 day Manual physical anthropometry of waist and hip circumferences
Hand-grip strength 1 day Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
Isokinetic peak torque 1 day 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
Lean mass by DXA 1 day Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Isometric peak torque 1 day 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
Fasting HbA1c levels 1 day Measure fasting HbA1c levels
Fasting insulin levels 1 day Measure fasting insulin levels
Fasting cholesterol levels 1 day Measure fasting cholesterol levels
Fasting triglycerides levels 1 day Measure fasting triglycerides levels
Fasting glucose levels 1 day Measure fasting glucose levels
- Secondary Outcome Measures
Name Time Method Changes in isometric peak torque 24 weeks 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
Changes in WHR 24 weeks Measure changes in WHR during intervention
Changes in isokinetic peak torque 24 weeks 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.
Body circumference from 2D imaging 24 weeks 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.
Systolic and Diastolic blood pressure levels will be assessed 24 weeks Manually measure systolic and diastolic blood pressure levels.
Changes in lean mass 24 weeks Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data.
Changes in automatic 3DO scan measurement 24 weeks Changes of automated 3DO measurements during intervention
Fat loss 24 weeks Measure changes in fat mass during intervention using DXA data.
Total Body Water 24 weeks Measure total body water (L) provided by bioelectrical impedance analysis
Diet History Questionnaire II 24 weeks The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions
Phase angle 24 weeks Phase angle \[PhA(°) = (reactance/electrical resistance) × (180°/Π)\] will be measured in degrees using bioelectrical impedance analysis.
Percent body fat 24 weeks Measure percent body fat provided by bioelectrical impedance analysis.
Trial Locations
- Locations (3)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States