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Completed

NCT Number: NCT03637855

Shape Up! Adults Study

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Primary outcomes

  1. Fat mass

    Time frame: 1 day

    Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

  2. Lean mass

    Time frame: 1 day

    Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

  3. Bone mass

    Time frame: 1 day

    Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total)

  4. Waist to Hip ratio (WHR) from manual tape measurement

    Time frame: 1 day

    Manual physical anthropometry of waist and hip circumferences

  5. Automatic 3D optical (3DO) scan measurement

    Time frame: 1 day

    Automated 3DO measurements generate the following: 476 girth, length, and volume measurements across the whole body.

  6. HUMAC NORM

    Time frame: 1 day

    Will measure isokinetic strength of knee and back to assess muscle function

  7. Jamar hydraulic hand dynamometer

    Time frame: 1 day

    Will measure grip strength to assess muscle function

  8. Fasting glucose levels

    Time frame: 1 day

    Measure fasting glucose levels

  9. Fasting HbA1c levels

    Time frame: 1 day

    Measure fasting HbA1c levels

  10. Fasting insulin levels

    Time frame: 1 day

    Measure fasting insulin levels

  11. Fasting cholesterol levels

    Time frame: 1 day

    Measure fasting cholesterol levels

  12. Fasting triglycerides levels

    Time frame: 1 day

    Measure fasting triglycerides levels

Other outcomes

  1. Fat loss

    Time frame: 24 weeks

    Measure changes in fat mass during intervention using DXA data.

  2. Changes in lean mass

    Time frame: 24 weeks

    Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data

  3. Changes in WHR

    Time frame: 24 weeks

    Measure changes in WHR during intervention

  4. Changes in automatic 3DO scan measurement

    Time frame: 24 weeks

    Changes of automated 3DO measurements during intervention

  5. changes in HUMAC NORM measurement

    Time frame: 24 weeks

    changes of isokinetic strength of knee and back to assess muscle function

  6. changes in Jamar hydraulic hand dynamometer measurement

    Time frame: 24 weeks

    changes of grip strength to assess muscle function

  7. Bioelectrical impedance analysis (BIA) measurements

    Time frame: 1 day

    measurement 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.

  8. Body shape from 2D imaging

    Time frame: 1 day

    Through the use of images from a conventional digital camera estimated body dimension will be obtained

  9. Blood pressure levels

    Time frame: 1 day

    Manually measure blood pressure.

  10. Diet History Questionnaire II

    Time frame: 1 day

    The Diet History questionnaire II estimates a participants nutrition intake by asking the participant a series of questions

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2018
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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