Shape Up! Kids Study

January 19, 2023 updated by: University of Hawaii

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat mass by DXA
Time Frame: 1 day
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
Time Frame: 1 day
Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
1 day
Bone mass by DXA
Time Frame: 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
1 day
Fat mass by MRI
Time Frame: 1 day
Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
1 day
Lean mass by MRI
Time Frame: 1 day
Measure lean mass (arms, legs, trunk, and total) using MRI data
1 day
Waist to Hip ratio (WHR) from manual tape measurement
Time Frame: 1 day
Manual physical anthropometry of waist and hip circumferences
1 day
Automatic 3D optical (3DO) scan measurement
Time Frame: 1 day
Automated 3DO measurement generated across the body
1 day
Hand-grip strength
Time Frame: 1 day
Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
1 day
Isokinetic peak torque
Time Frame: 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
1 day
Isometric peak torque
Time Frame: 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
1 day
Fasting glucose levels
Time Frame: 1 day
Measure fasting glucose levels
1 day
Fasting HbA1c levels
Time Frame: 1 day
Measure fasting HbA1c levels
1 day
Fasting insulin levels
Time Frame: 1 day
Measure fasting insulin levels
1 day
Fasting cholesterol levels
Time Frame: 1 day
Measure fasting cholesterol levels
1 day
Fasting triglycerides levels
Time Frame: 1 day
Measure fasting triglycerides levels
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat loss
Time Frame: 24 weeks
Measure changes in fat mass during intervention using DXA data.
24 weeks
Changes in lean mass
Time Frame: 24 weeks
Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data.
24 weeks
Changes in WHR
Time Frame: 24 weeks
Measure changes in WHR during intervention
24 weeks
Changes in automatic 3DO scan measurement
Time Frame: 24 weeks
Changes of automated 3DO measurements during intervention
24 weeks
Changes in isokinetic peak torque
Time Frame: 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.
24 weeks
Changes in isometric peak torque
Time Frame: 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
24 weeks
Total Body Water
Time Frame: 24 weeks
Measure total body water (L) provided by bioelectrical impedance analysis
24 weeks
Phase angle
Time Frame: 24 weeks
Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis.
24 weeks
Percent body fat
Time Frame: 24 weeks
Measure percent body fat provided by bioelectrical impedance analysis.
24 weeks
Body circumference from 2D imaging
Time Frame: 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.
24 weeks
Systolic and Diastolic blood pressure levels will be assessed
Time Frame: 24 weeks
Manually measure systolic and diastolic blood pressure levels.
24 weeks
Diet History Questionnaire II
Time Frame: 24 weeks
The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hawaii

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco
Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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