Shape Up! Kids Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 3
- 主要终点
- Fasting glucose levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fasting glucose levels
时间窗: 1 day
Measure fasting glucose levels
Fat mass by MRI
时间窗: 1 day
Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
Fat mass by DXA
时间窗: 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
时间窗: 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
时间窗: 1 day
Automated 3DO measurement generated across the body
Lean mass by MRI
时间窗: 1 day
Measure lean mass (arms, legs, trunk, and total) using MRI data
Waist to Hip ratio (WHR) from manual tape measurement
时间窗: 1 day
Manual physical anthropometry of waist and hip circumferences
Hand-grip strength
时间窗: 1 day
Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
Isokinetic peak torque
时间窗: 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
时间窗: 1 day
Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Isometric peak torque
时间窗: 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
时间窗: 1 day
Measure fasting HbA1c levels
Fasting insulin levels
时间窗: 1 day
Measure fasting insulin levels
Fasting cholesterol levels
时间窗: 1 day
Measure fasting cholesterol levels
Fasting triglycerides levels
时间窗: 1 day
Measure fasting triglycerides levels
次要结局
- Systolic and Diastolic blood pressure levels will be assessed(24 weeks)
- Changes in isometric peak torque(24 weeks)
- Changes in WHR(24 weeks)
- Changes in isokinetic peak torque(24 weeks)
- Body circumference from 2D imaging(24 weeks)
- Changes in lean mass(24 weeks)
- Changes in automatic 3DO scan measurement(24 weeks)
- Fat loss(24 weeks)
- Total Body Water(24 weeks)
- Diet History Questionnaire II(24 weeks)
- Phase angle(24 weeks)
- Percent body fat(24 weeks)