Clinical trial NCT03637855: Shape Up! Adults Study
Official title: Optical Body Composition and Health Assessment (Shape Up! Adults) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Fat mass
timeFrame: 1 day
measure: Lean mass
timeFrame: 1 day
measure: Bone mass
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: HUMAC NORM
timeFrame: 1 day
measure: Jamar hydraulic hand dynamometer
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:
Other 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 HUMAC NORM measurement
timeFrame: 24 weeks
measure: changes in Jamar hydraulic hand dynamometer measurement
timeFrame: 24 weeks
measure: Bioelectrical impedance analysis (BIA) measurements
timeFrame: 1 day
measure: Body shape from 2D imaging
timeFrame: 1 day
measure: Blood pressure levels
timeFrame: 1 day
measure: Diet History Questionnaire II
timeFrame: 1 day
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: John Shepherd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong MC, McCarthy C, Fearnbach N, Yang S, Shepherd J, Heymsfield SB. Emergence of the obesity epidemic: 6-decade visualization with humanoid avatars. Am J Clin Nutr. 2022 Apr 1;115(4):1189-1193. doi: 10.1093/ajcn/nqac005.
citation: Panizza CE, Wong MC, Kelly N, Liu YE, Shvetsov YB, Lowe DA, Weiss EJ, Heymsfield SB, Kennedy S, Boushey CJ, Maskarinec G, Shepherd JA. Diet Quality and Visceral Adiposity among a Multiethnic Population of Young, Middle, and Older Aged Adults. Curr Dev Nutr. 2020 May 26;4(6):nzaa090. doi: 10.1093/cdn/nzaa090. eCollection 2020 Jun.
citation: Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, Kelly N, Liu YE, Philip E, Vittinghoff E, Heymsfield SB, Olgin JE, Shepherd JA, Weiss EJ. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1491-1499. doi: 10.1001/jamainternmed.2020.4153.
citation: Harty PS, Sieglinger B, Heymsfield SB, Shepherd JA, Bruner D, Stratton MT, Tinsley GM. Novel body fat estimation using machine learning and 3-dimensional optical imaging. Eur J Clin Nutr. 2020 May;74(5):842-845. doi: 10.1038/s41430-020-0603-x. Epub 2020 Mar 16.
citation: Ng BK, Sommer MJ, Wong MC, Pagano I, Nie Y, Fan B, Kennedy S, Bourgeois B, Kelly N, Liu YE, Hwaung P, Garber AK, Chow D, Vaisse C, Curless B, Heymsfield SB, Shepherd JA. Detailed 3-dimensional body shape features predict body composition, blood metabolites, and functional strength: the Shape Up! studies. Am J Clin Nutr. 2019 Dec 1;110(6):1316-1326. doi: 10.1093/ajcn/nqz218.