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Shape Up! Kids 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: NCT03706612
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
University of California, San Francisco
Pennington Biomedical Research Center
Information provided by (Responsible Party):
University of Hawaii

Tracking Information
First Submitted Date October 11, 2018
First Posted Date October 16, 2018
Last Update Posted Date May 7, 2021
Actual Study Start Date April 1, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2019)
  • Fat mass by DXA [ 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 by DXA [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
  • Bone mass by DXA [ Time Frame: 1 day ]
    Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
  • Fat mass by MRI [ Time Frame: 1 day ]
    Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
  • Lean mass by MRI [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using MRI data
  • 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 measurement generated across the body
  • Hand-grip strength [ Time Frame: 1 day ]
    Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
  • Isokinetic peak torque [ Time Frame: 1 day ]
    Measure the peak torque value (FT-LBS) generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
  • Isometric peak torque [ Time Frame: 1 day ]
    Measure the peak torque value (FT-LBS) generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
  • 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: October 11, 2018)
  • Fat mass by DXA [ 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 by DXA [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data
  • Bone mass by DXA [ Time Frame: 1 day ]
    Measure bone mass (arms, legs, lumbar spine, and total) and Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
  • Fat mass by MRI [ Time Frame: 1 day ]
    Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data
  • Lean mass by MRI [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using MRI data
  • 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
  • Hand-grip strength [ Time Frame: 1 day ]
    Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.
  • Isokinetic peak torque [ Time Frame: 1 day ]
    Measure the peak torque value (FT-LBS) generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
  • Isometric peak torque [ Time Frame: 1 day ]
    Measure the peak torque value (FT-LBS) generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
  • 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
 (submitted: December 6, 2019)
  • 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 isokinetic peak torque [ Time Frame: 24 weeks ]
    Measure the change in peak torque value generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention.
  • Changes in isometric peak torque [ Time Frame: 24 weeks ]
    Measure the change in peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention
  • Total Body Water [ Time Frame: 24 weeks ]
    Measure total body water (L) provided by bioelectrical impedance analysis
  • Phase angle [ Time Frame: 24 weeks ]
    Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis.
  • Percent body fat [ Time Frame: 24 weeks ]
    Measure percent body fat provided by bioelectrical impedance analysis.
  • Body circumference from 2D imaging [ Time Frame: 24 weeks ]
    A conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body circumference will be estimated using these images.
  • Systolic and Diastolic blood pressure levels will be assessed [ Time Frame: 24 weeks ]
    Manually measure systolic and diastolic blood pressure levels.
  • Diet History Questionnaire II [ Time Frame: 24 weeks ]
    The Diet History Questionnaire II estimates the participants nutrition intake by asking the participant a series of questions
Original Secondary Outcome Measures
 (submitted: October 11, 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 isokinetic peak torque [ Time Frame: 24 weeks ]
    Measure the change in peak torque value generated during isokinetic knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention.
  • Changes in isometric peak torque [ Time Frame: 24 weeks ]
    Measure the change in peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device pre and post intervention
  • Total Body Water [ Time Frame: 24 weeks ]
    Measure total body water (L) provided by bioelectrical impedance analysis
  • Phase angle [ Time Frame: 24 weeks ]
    Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis.
  • Percent body fat [ Time Frame: 24 weeks ]
    Measure percent body fat provided by bioelectrical impedance analysis.
  • Body circumference from 2D imaging [ Time Frame: 24 weeks ]
    A conventional digital camera will be used to capture 2D images of participants in a standardized pose. Body circumference will be estimated using these images.
  • Blood pressure levels [ Time Frame: 24 weeks ]
    Manually measure blood pressure.
  • Self-reported energy intake [ Time Frame: 24 weeks ]
    Measured as kcal/day by food frequency questionnaire (Diet History Questionnaire II).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Shape Up! Kids Study
Official Title Shape Up! Kids Study
Brief Summary

Identify the unique associations of body shape to body composition and bone density indices in a pediatric population that represents the variance of sex, age, BMI-Z, and ethnicity found in the US population.

Describe the precision and accuracy of optical scans to monitor change in body composition, bone density and metabolic health interventions.

Estimate the level of association of optical to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI-Z.

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

The investigator will recruit a stratified sample of 720 participants, approximately 360 from each site, using the following equally-weighed stratifications: sex, age (5-10, 11-14, 15-17 years), BMI-Z score (less than -2, -2 to 1, 1 to 2, and greater than 2) and ethnicity (White, Black, Mexican-American, Asian and Native Hawaiian or Other Pacific Islander).

Within this sample, the investigator will include up to 36 participants with very low and high BMI by special recruitments from the facilities. The remainder of the participants will be recruited as a sample of convenience using local advertisements around the specified facilities.

Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Wong MC, Ng BK, Kennedy SF, Hwaung P, Liu EY, Kelly NN, Pagano IS, Garber AK, Chow DC, Heymsfield SB, Shepherd JA. Children and Adolescents' Anthropometrics Body Composition from 3-D Optical Surface Scans. Obesity (Silver Spring). 2019 Nov;27(11):1738-1749. doi: 10.1002/oby.22637.

*   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: October 11, 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:

    • 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 body composition from what is typical for age, sex, ethnicity, and BMI.

Exclusion Criteria:

  • any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment
  • 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 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: John Shepherd, PhD 808-440-5234 johnshep@hawaii.edu
Contact: Nisa Kelly 808-440-5234 nnkelly@hawaii.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03706612
Other Study ID Numbers R01DK111698( 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
  • University of California, San Francisco
  • Pennington Biomedical Research Center
Investigators Not Provided
PRS Account University of Hawaii
Verification Date May 2021