Clinical trial NCT03706612: Shape Up! Kids Study
Official title: Shape Up! Kids Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Pennington Biomedical Research Center
First posted: 2018-10-16
Enrollment: 430
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Fat mass by DXA
timeFrame: 1 day
measure: Lean mass by DXA
timeFrame: 1 day
measure: Bone mass by DXA
timeFrame: 1 day
measure: Fat mass by MRI
timeFrame: 1 day
measure: Lean mass by MRI
timeFrame: 1 day
measure: Waist to Hip ratio (WHR) from manual tape measurement
timeFrame: 1 day
measure: Automatic 3D optical (3DO) scan measurement
timeFrame: 1 day
measure: Hand-grip strength
timeFrame: 1 day
measure: Isokinetic peak torque
timeFrame: 1 day
measure: Isometric peak torque
timeFrame: 1 day
measure: Fasting glucose levels
timeFrame: 1 day
measure: Fasting HbA1c levels
timeFrame: 1 day
measure: Fasting insulin levels
timeFrame: 1 day
measure: Fasting cholesterol levels
timeFrame: 1 day
measure: Fasting triglycerides levels
timeFrame: 1 day
Secondary outcomes:
measure: Fat loss
timeFrame: 24 weeks
measure: Changes in lean mass
timeFrame: 24 weeks
measure: Changes in WHR
timeFrame: 24 weeks
measure: Changes in automatic 3DO scan measurement
timeFrame: 24 weeks
measure: Changes in isokinetic peak torque
timeFrame: 24 weeks
measure: Changes in isometric peak torque
timeFrame: 24 weeks
measure: Total Body Water
timeFrame: 24 weeks
measure: Phase angle
timeFrame: 24 weeks
measure: Percent body fat
timeFrame: 24 weeks
measure: Body circumference from 2D imaging
timeFrame: 24 weeks
measure: Systolic and Diastolic blood pressure levels will be assessed
timeFrame: 24 weeks
measure: Diet History Questionnaire II
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: 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.
citation: 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.