NCT03706612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

5.8 years

First QC Date

October 11, 2018

Last Update Submit

January 19, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (12)

  • Fat loss

    24 weeks

  • Changes in lean mass

    24 weeks

  • Changes in WHR

    24 weeks

  • Changes in automatic 3DO scan measurement

    24 weeks

  • Changes in isokinetic peak torque

    24 weeks

  • +7 more secondary outcomes

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

  • Marazzato F, McCarthy C, Field RH, Nguyen H, Nguyen T, Shepherd JA, Tinsley GM, Heymsfield SB. Advances in digital anthropometric body composition assessment: neural network algorithm prediction of appendicular lean mass. Eur J Clin Nutr. 2024 May;78(5):452-454. doi: 10.1038/s41430-023-01396-3. Epub 2023 Dec 23.

    PMID: 38142263DERIVED

  • 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.

    PMID: 35610336DERIVED

  • 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.

    PMID: 31689009DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 16, 2018

Study Start

April 1, 2017

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

US(3)