Shape Up! Kids Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigator will recruit a stratified sample of 720 participants, approximately 360 from each site, using the following equally-weighed stratifications: sex, age (5-10, 11-14, 15-17 years), BMI-Z score (less than -2, -2 to 1, 1 to 2, and greater than 2) and ethnicity (White, Black, Mexican-American, Asian and Native Hawaiian or Other Pacific Islander).

Within this sample, the investigator will include up to 36 participants with very low and high BMI by special recruitments from the facilities. The remainder of the participants will be recruited as a sample of convenience using local advertisements around the specified facilities.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: University of California, San Francisco; Pennington Biomedical Research Center

Publications and helpful links

General Publications

• Bennett J, Wong MC, McCarthy C, Fearnbach N, Queen K, Shepherd J, Heymsfield SB. Emergence of the adolescent obesity epidemic in the United States: five-decade visualization with humanoid avatars. Int J Obes (Lond). 2022 Sep;46(9):1587-1590. doi: 10.1038/s41366-022-01153-9. Epub 2022 May 24.
• Wong MC, Ng BK, Kennedy SF, Hwaung P, Liu EY, Kelly NN, Pagano IS, Garber AK, Chow DC, Heymsfield SB, Shepherd JA. Children and Adolescents' Anthropometrics Body Composition from 3-D Optical Surface Scans. Obesity (Silver Spring). 2019 Nov;27(11):1738-1749. doi: 10.1002/oby.22637.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R01DK111698 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No