Shape Up! Kids Study

• ClinicalTrials.gov Identifier: NCT03706612
• Recruitment Status: Completed
• First Posted: October 16, 2018
• Last Update Posted: January 23, 2023
• Sponsor: University of Hawaii
• Collaborators: University of California, San Francisco; Pennington Biomedical Research Center
• Information provided by (Responsible Party): University of Hawaii

Study Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 430 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Shape Up! Kids Study
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: January 4, 2023
• Actual Study Completion Date: January 4, 2023

Groups and Cohorts

Outcome Measures

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 measurement generated across the 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. Systolic and Diastolic blood pressure levels will be assessed [ Time Frame: 24 weeks ]
    Manually measure systolic and diastolic blood pressure levels.
12. 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

Eligibility Criteria

• 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

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.

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.

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

United States, Hawaii

University of Hawaii Cancer Center

Honolulu, Hawaii, United States, 96813

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

University of Hawaii

University of California, San Francisco

Pennington Biomedical Research Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bennett J, Wong MC, McCarthy C, Fearnbach N, Queen K, Shepherd J, Heymsfield SB. Emergence of the adolescent obesity epidemic in the United States: five-decade visualization with humanoid avatars. Int J Obes (Lond). 2022 Sep;46(9):1587-1590. doi: 10.1038/s41366-022-01153-9. Epub 2022 May 24.

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.

• Responsible Party: University of Hawaii
• ClinicalTrials.gov Identifier: NCT03706612
• Other Study ID Numbers: R01DK111698 ( U.S. NIH Grant/Contract )
• First Posted: October 16, 2018
• Last Update Posted: January 23, 2023
• Last Verified: January 2023

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