Shape Up! Kids Study

Healthy Clinical Trial

Official title:

Shape Up! Kids Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706612
• Other study ID #: R01DK111698
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: January 4, 2023

Study information

• Verified date: January 2023
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
University of Hawaii	Pennington Biomedical Research Center, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lean mass by DXA	Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data	1 day
Primary	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
Primary	Fat mass by MRI	Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data	1 day
Primary	Lean mass by MRI	Measure lean mass (arms, legs, trunk, and total) using MRI data	1 day
Primary	Waist to Hip ratio (WHR) from manual tape measurement	Manual physical anthropometry of waist and hip circumferences	1 day
Primary	Automatic 3D optical (3DO) scan measurement	Automated 3DO measurement generated across the body	1 day
Primary	Hand-grip strength	Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.	1 day
Primary	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
Primary	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
Primary	Fasting glucose levels	Measure fasting glucose levels	1 day
Primary	Fasting HbA1c levels	Measure fasting HbA1c levels	1 day
Primary	Fasting insulin levels	Measure fasting insulin levels	1 day
Primary	Fasting cholesterol levels	Measure fasting cholesterol levels	1 day
Primary	Fasting triglycerides levels	Measure fasting triglycerides levels	1 day
Secondary	Fat loss	Measure changes in fat mass during intervention using DXA data.	24 weeks
Secondary	Changes in lean mass	Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data.	24 weeks
Secondary	Changes in WHR	Measure changes in WHR during intervention	24 weeks
Secondary	Changes in automatic 3DO scan measurement	Changes of automated 3DO measurements during intervention	24 weeks
Secondary	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
Secondary	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
Secondary	Total Body Water	Measure total body water (L) provided by bioelectrical impedance analysis	24 weeks
Secondary	Phase angle	Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/?)] will be measured in degrees using bioelectrical impedance analysis.	24 weeks
Secondary	Percent body fat	Measure percent body fat provided by bioelectrical impedance analysis.	24 weeks
Secondary	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
Secondary	Systolic and Diastolic blood pressure levels will be assessed	Manually measure systolic and diastolic blood pressure levels.	24 weeks
Secondary	Diet History Questionnaire II	The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions	24 weeks