Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Shape Up! Adults Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637855
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Tracking Information
First Submitted Date July 19, 2018
First Posted Date August 20, 2018
Last Update Posted Date May 7, 2021
Actual Study Start Date October 1, 2016
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2019)
  • 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
Original Primary Outcome Measures
 (submitted: August 16, 2018)
  • 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.
  • Muscle function [ Time Frame: 1 day ]
    Will measure isokinetic and isometric leg strength
  • 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2020)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: August 16, 2018)
  • 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 muscle function [ Time Frame: 24 weeks ]
    Will measure isokinetic and isometric leg strength pre and post intervention
  • Bioelectrical impedance analysis (BIA) measurements [ Time Frame: 1 day ]
    BIA measurements will include total body water, impedance and phase angle, and percent body fat.
  • Body shape from 2D imaging [ Time Frame: 1 day ]
    A conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body height, width, length, and estimated circumferences will be calculated using these images.
  • Blood pressure levels [ Time Frame: 1 day ]
    Manually measure blood pressure.
  • Nutrition Intake [ Time Frame: 1 day ]
    Will estimate participants nutrition intake estimate using the Diet History Questionnaire II developed by the Risk Factor Assessment Branch at the NIH.
 
Descriptive Information
Brief Title Shape Up! Adults Study
Official Title Optical Body Composition and Health Assessment (Shape Up! Adults) Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

We will recruit a stratified sample of 720 participants, approximately 360 from each site, using the following equally-weighed stratifications: sex, age (18-40, 40-60, 60-80 years), BMI (less than 25, 25-30, 30 and above) and ethnicity (White, Black, Mexican-American, Asian and Native Hawaiian or Other Pacific Islander).

Within this sample, we will include up to 36 participants with very low and high BMI by special recruitments from our facilities Anorexia Nervosa (AN) and bariatric surgery clinics. The remainder of the participants will be recruited as a sample of convenience using local advertisements around our facilities.

Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2018)
720
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nisa Kelly nnkelly@hawaii.edu
Contact: Leila Kazemi lkazemi@hawaii.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03637855
Other Study ID Numbers R01DK109008( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Hawaii
Study Sponsor University of Hawaii
Collaborators Not Provided
Investigators
Principal Investigator: John Shepherd, PhD University of Hawaii Cancer Research Center
PRS Account University of Hawaii
Verification Date May 2021