Shape Up! Adults Study
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|ClinicalTrials.gov Identifier: NCT03637855|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 17, 2020
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||720 participants|
|Official Title:||Optical Body Composition and Health Assessment (Shape Up! Adults) Study|
|Actual Study Start Date :||October 1, 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
- 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
- Lean mass [ Time Frame: 1 day ]Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
- Bone mass [ Time Frame: 1 day ]Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total)
- Waist to Hip ratio (WHR) from manual tape measurement [ Time Frame: 1 day ]Manual physical anthropometry of waist and hip circumferences
- 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.
- HUMAC NORM [ Time Frame: 1 day ]Will measure isokinetic strength of knee and back to assess muscle function
- Jamar hydraulic hand dynamometer [ Time Frame: 1 day ]Will measure grip strength to assess muscle function
- Fasting glucose levels [ Time Frame: 1 day ]Measure fasting glucose levels
- Fasting HbA1c levels [ Time Frame: 1 day ]Measure fasting HbA1c levels
- Fasting insulin levels [ Time Frame: 1 day ]Measure fasting insulin levels
- Fasting cholesterol levels [ Time Frame: 1 day ]Measure fasting cholesterol levels
- Fasting triglycerides levels [ Time Frame: 1 day ]Measure fasting triglycerides levels
- Fat loss [ Time Frame: 24 weeks ]Measure changes in fat mass during intervention using DXA data.
- Changes in lean mass [ Time Frame: 24 weeks ]Measure changes in lean mass (arms, legs, trunk, and total) during intervention using DXA data
- Changes in WHR [ Time Frame: 24 weeks ]Measure changes in WHR during intervention
- Changes in automatic 3DO scan measurement [ Time Frame: 24 weeks ]Changes of automated 3DO measurements during intervention
- changes in HUMAC NORM measurement [ Time Frame: 24 weeks ]changes of isokinetic strength of knee and back to assess muscle function
- changes in Jamar hydraulic hand dynamometer measurement [ Time Frame: 24 weeks ]changes of grip strength to assess muscle function
- 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.
- 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
- Blood pressure levels [ Time Frame: 1 day ]Manually measure blood pressure.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637855
|Contact: Nisa Kellyfirstname.lastname@example.org|
|Contact: Leila Kazemiemail@example.com|
|United States, Hawaii|
|University of Hawaii Cancer Center||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Nisa Kelly firstname.lastname@example.org|
|Principal Investigator:||John Shepherd, PhD||University of Hawaii Cancer Research Center|