Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001135101
Ethics application status
Approved
Date submitted
1/08/2019
Date registered
14/08/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of quick and portable methods of body composition assessment
Scientific title
Evaluation of a new, multi-compartment model for field-based body composition assessment
Secondary ID [1] 298816 0
Nil known
Universal Trial Number (UTN)
U1111-1237-8103
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accurate assessment of body composition 313857 0
Condition category
Condition code
Diet and Nutrition 312267 312267 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In a multi-ethnic group of young adults of varying body size, we will compare body composition measurements made using state-of-the-art 3-dimensional photonic body surface scanning (approx. 5 minutes duration) coupled with bioimpedance spectrometry (approx. 15 minutes duration) and skin-fold measurements (approx. 15 minutes duration). These results will be compared to those obtained by the dual x-ray absorptiometry reference technique (15- 20 minutes duration). This evaluation will be conducted in both men and women, and in people of different body sizes (i.e., normal-weight, overweight and obese) as part of one study visit (approx. 1 hour).

This study will be conducted by researchers from the Human Nutrition and Body Composition Units at the University of Auckland in cooperation with researchers from the Defence Technology Agency of the New Zealand Defence Force.
Intervention code [1] 315157 0
Diagnosis / Prognosis
Comparator / control treatment
Dual xray absorptiometry (DXA) technique
Control group
Active

Outcomes
Primary outcome [1] 320908 0
Measure of total body water obtained by bioimpedence spectroscopy (BIS).
Timepoint [1] 320908 0
One-time measurement only
Primary outcome [2] 320909 0
Measure of fat mass obtained by bioimpedence spectroscopy (BIS).
Timepoint [2] 320909 0
One-time measurement only
Primary outcome [3] 321021 0
Measure of fat-free mass obtained by bioimpedence spectroscopy (BIS).
Timepoint [3] 321021 0
One-time measurement only
Secondary outcome [1] 373310 0
% Fat mass derived from bio-impedance spectroscopy
Timepoint [1] 373310 0
One-time measurement only
Secondary outcome [2] 373311 0
% Fat Mass derived from 3D photonic scanning
Timepoint [2] 373311 0
One-time measurement only
Secondary outcome [3] 373312 0
% Fat Mass derived from skin-fold measurement
Timepoint [3] 373312 0
One-time measurement only
Secondary outcome [4] 373313 0
% Fat Mass derived from the "gold standard" body composition method of dual x-ray absorptiometry (DXA)
Timepoint [4] 373313 0
One-time measurement only
Secondary outcome [5] 373705 0
Primary Outcome: Measure of total body water obtained by dual x-ray absorptiometry (DXA)
Timepoint [5] 373705 0
One-time measurement only
Secondary outcome [6] 373706 0
Primary Outcome: Measure of fat mass obtained by dual x-ray absorptiometry (DXA)
Timepoint [6] 373706 0
One-time measurement only
Secondary outcome [7] 373707 0
Primary Outcome: Measure of fat-free mass obtained by dual x-ray absorptiometry (DXA)
Timepoint [7] 373707 0
One-time measurement only

Eligibility
Key inclusion criteria
>Body Mass Indes (BMI) between 18.5 and 40 kg/m2

>Willing to comply with the scanning clothing requirements during the 3D photonic scanning i,e, wearing form-fitting clothes e.g. swimsuit, crop top and bike shorts, or close fitting underwear. This is to ensure accuracy of the measurement.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
>Pregnancy

>Any form of implant (e.g. implanted cardioverter-defibrillator (ICD), prostheses or metal implants, a pace-maker, cochlear implant)

>Amputees

>Disorder of fluid balance (e.g. oedema, dehydration)

>Any other condition associated with abnormal fluid status (e.g. kidney disease, organ failure, uncontrolled diabetes, malabsorptive syndromes, inflammatory bowel disease, use of diuretic medications or corticosteroids)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a single-centre, cross-sectional observational study. Statistical comparisons will be made between methodologies in the full study cohort, with subgroup analyses according to sex, ethnicity and body mass index (BMI) classification. It is not possible to determine a priori the sample size required to make a predictive equation of body composition accurate, since this depends on the relationships between the dependent variable and its variance, and the number and variance of the predictor(s). However, based on the relation between sample size and statistical power for the increase in R2 when a predictor variable is added during the development of an equation, an estimate of the sample size can be made; statistical power in this context refers to the probability that the increase in R2 due to the addition of another variable is significant. Guo and colleagues (Guo, Chumlea, & Cockram, 1996) have estimated that probability is 0.96 for a sample of 100, and on this basis have proposed this as an appropriate sample size in body composition studies.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
16/08/2019
Actual
17/08/2019
Date of last participant enrolment
Anticipated
1/07/2020
Actual
4/02/2020
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
400
Accrual to date
339
Final
Recruitment outside Australia
Country [1] 21733 0
New Zealand
State/province [1] 21733 0
Auckland

Funding & Sponsors
Funding source category [1] 303369 0
University
Name [1] 303369 0
University of Auckland
Country [1] 303369 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jennifer Miles-Chan
Address
School of Biological Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 303486 0
None
Name [1] 303486 0
Address [1] 303486 0
Country [1] 303486 0
Other collaborator category [1] 280887 0
Individual
Name [1] 280887 0
Helen Kilding
Address [1] 280887 0
Research Leader - Performance and Health Defence Technology Agency New Zealand Defence Force Jim Titchener Parade, Stanley Point, Auckland 0624
Country [1] 280887 0
New Zealand
Other collaborator category [2] 280888 0
Individual
Name [2] 280888 0
A/Professor Lindsay Plank
Address [2] 280888 0
Body Composition Unit School of Medicine University of Auckland Auckland Hospital Support Building 2 Park Road Grafton Auckland 1023
Country [2] 280888 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303899 0
Northern A Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 303899 0
Ethics committee country [1] 303899 0
New Zealand
Date submitted for ethics approval [1] 303899 0
31/05/2019
Approval date [1] 303899 0
11/06/2019
Ethics approval number [1] 303899 0
19/NTA/76

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95178 0
Dr Jennifer Miles-Chan
Address 95178 0
School of Biological Sciences The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
Country 95178 0
New Zealand
Phone 95178 0
+64 9 923 4322
Fax 95178 0
Email 95178 0
[email protected]
Contact person for public queries
Name 95179 0
Jennifer Miles-Chan
Address 95179 0
School of Biological Sciences The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
Country 95179 0
New Zealand
Phone 95179 0
+64 9 923 4322
Fax 95179 0
Email 95179 0
[email protected]
Contact person for scientific queries
Name 95180 0
Jennifer Miles-Chan
Address 95180 0
School of Biological Sciences The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
Country 95180 0
New Zealand
Phone 95180 0
+64 9 923 4322
Fax 95180 0
Email 95180 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the primary sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All individual participant data collected during the trial, after de-identification, underlying published results only.

What types of analyses could be done with individual participant data?
• Only to achieve aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Availability of the above data will start immediately post-publication. No end date is yet determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by the primary sponsor, with a requirement to sign approved access agreement. Dr Jennifer Miles-Chan, the primary sponsor, can be contacted on [email protected] or +64 9 923 4322

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3683Ethical approval    Study-related document.pdf
3684Informed consent form    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.