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Shape Up! Kids Study

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ClinicalTrials.gov Identifier: NCT03706612
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

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.


Condition or disease
Healthy

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shape Up! Kids Study
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  1. 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

  2. Lean mass by DXA [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using Dual energy X-ray absorptiometry (DXA) data

  3. 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

  4. Fat mass by MRI [ Time Frame: 1 day ]
    Measure fat mass and percent fat (arms, legs, trunk, visceral, and total) using MRI data

  5. Lean mass by MRI [ Time Frame: 1 day ]
    Measure lean mass (arms, legs, trunk, and total) using MRI data

  6. Waist to Hip ratio (WHR) from manual tape measurement [ Time Frame: 1 day ]
    Manual physical anthropometry of waist and hip circumferences

  7. 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

  8. Hand-grip strength [ Time Frame: 1 day ]
    Measured by using a hand-grip dynamometer (JAMAR) as a measure of strength and physical capacity.

  9. 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

  10. 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

  11. Fasting glucose levels [ Time Frame: 1 day ]
    Measure fasting glucose levels

  12. Fasting HbA1c levels [ Time Frame: 1 day ]
    Measure fasting HbA1c levels

  13. Fasting insulin levels [ Time Frame: 1 day ]
    Measure fasting insulin levels

  14. Fasting cholesterol levels [ Time Frame: 1 day ]
    Measure fasting cholesterol levels

  15. Fasting triglycerides levels [ Time Frame: 1 day ]
    Measure fasting triglycerides levels


Secondary Outcome Measures :
  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 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.

  6. 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

  7. Total Body Water [ Time Frame: 24 weeks ]
    Measure total body water (L) provided by bioelectrical impedance analysis

  8. Phase angle [ Time Frame: 24 weeks ]
    Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis.

  9. Percent body fat [ Time Frame: 24 weeks ]
    Measure percent body fat provided by bioelectrical impedance analysis.

  10. 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.

  11. Blood pressure levels [ Time Frame: 24 weeks ]
    Manually measure blood pressure.

  12. Self-reported energy intake [ Time Frame: 24 weeks ]
    Measured as kcal/day by food frequency questionnaire (Diet History Questionnaire II).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (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, we will include up to 36 participants with very low and high BMI by special recruitments from our facilities. The remainder of the participants will be recruited as a sample of convenience using local advertisements around our facilities.

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 their body composition from what is typical for their 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.

Information from the National Library of Medicine

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): NCT03706612


Contacts
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Contact: John Shepherd, PhD 808-440-5234 johnshep@hawaii.edu
Contact: Nisa Kelly 808-440-5234 nnkelly@hawaii.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Andrea Garber, PhD    415-514-2180    andrea.garber@ucsf.edu   
United States, Hawaii
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Nisa Kelly    808-440-5234    nnkelly@hawaii.edu   
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Steven Heymsfield, MD    225-763-2541    steven.heymsfield@pbrc.edu   
Sponsors and Collaborators
University of Hawaii

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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03706612     History of Changes
Other Study ID Numbers: R01DK111698 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No