Shape Up! Adults Study

Completed

• Conditions: Healthy

• Registration Number: NCT03637855
• Lead Sponsor: University of Hawaii

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting insulin levels	1 day	Measure fasting insulin levels
HUMAC NORM	1 day	Will measure isokinetic strength of knee and back to assess muscle function
Fat mass	1 day	Measure fat mass and percent fat (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Lean mass	1 day	Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
Bone mass	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	1 day	Manual physical anthropometry of waist and hip circumferences
Automatic 3D optical (3DO) scan measurement	1 day	Automated 3DO measurements generate the following: 476 girth, length, and volume measurements across the whole body.
Jamar hydraulic hand dynamometer	1 day	Will measure grip strength to assess muscle function
Fasting HbA1c levels	1 day	Measure fasting HbA1c levels
Fasting cholesterol levels	1 day	Measure fasting cholesterol levels
Fasting triglycerides levels	1 day	Measure fasting triglycerides levels
Fasting glucose levels	1 day	Measure fasting glucose levels

Trial Locations

Locations (1)

University of Hawaii Cancer Center; 🇺🇸 Honolulu, Hawaii, United States