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Shape Up! Adults Study

Optical Body Composition and Health Assessment (Shape Up! Adults) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03637855
Enrollment
696
Registered
2018-08-20
Start date
2016-10-01
Completion date
2021-12-31
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Identify the unique associations of body shape to body composition indices in a population that represents the variance of sex, age, BMI, and ethnicity found in the US population. Describe the precision and accuracy of 3DO scans to monitor change in body composition and metabolic health interventions. Estimate the level of association of 3DO to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI. 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.

Interventions

None listed

Sponsors

University of Hawaii
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy participants will be included in the study if they have a self-reported ability to: 1. walk one-quarter of a mile and climb 10 steps without difficulty, 2. perform activities of daily living (ADLs) without difficulty, and 3. have no life-threatening conditions or diseases that would alter their body composition from what is typical for their age, sex, ethnicity, and BMI.

Exclusion criteria

* Participants will be excluded if they have any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment or are 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.

Design outcomes

Primary

MeasureTime frameDescription
Fasting triglycerides levels1 dayMeasure fasting triglycerides levels
Lean mass1 dayMeasure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Bone mass1 dayMeasure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total)
Waist to Hip ratio (WHR) from manual tape measurement1 dayManual physical anthropometry of waist and hip circumferences
Automatic 3D optical (3DO) scan measurement1 dayAutomated 3DO measurements generate the following: 476 girth, length, and volume measurements across the whole body.
HUMAC NORM1 dayWill measure isokinetic strength of knee and back to assess muscle function
Jamar hydraulic hand dynamometer1 dayWill measure grip strength to assess muscle function
Fasting glucose levels1 dayMeasure fasting glucose levels
Fasting HbA1c levels1 dayMeasure fasting HbA1c levels
Fasting insulin levels1 dayMeasure fasting insulin levels
Fasting cholesterol levels1 dayMeasure fasting cholesterol levels
Fat mass1 dayMeasure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

Other

MeasureTime frameDescription
Changes in lean mass24 weeksMeasure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data
Changes in WHR24 weeksMeasure changes in WHR during intervention
Changes in automatic 3DO scan measurement24 weeksChanges of automated 3DO measurements during intervention
changes in HUMAC NORM measurement24 weekschanges of isokinetic strength of knee and back to assess muscle function
changes in Jamar hydraulic hand dynamometer measurement24 weekschanges of grip strength to assess muscle function
Bioelectrical impedance analysis (BIA) measurements1 daymeasurement of the conductance of water, fat, and muscle by placing electrodes on right and left ankles and index fingertips. The analysis measures the amount of water inside cells and outside cells as the amount of muscle and fat.
Body shape from 2D imaging1 dayThrough the use of images from a conventional digital camera estimated body dimension will be obtained
Blood pressure levels1 dayManually measure blood pressure.
Diet History Questionnaire II1 dayThe Diet History questionnaire II estimates a participants nutrition intake by asking the participant a series of questions
Fat loss24 weeksMeasure changes in fat mass during intervention using DXA data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026