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Trial registered on ANZCTR


Registration number
ACTRN12615001318572
Ethics application status
Approved
Date submitted
26/11/2015
Date registered
2/12/2015
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Low cost body composition measurement for nutrition assessment from birth up to 2 years
Scientific title
Validity of a low cost body composition measurement for nutrition assessment using Near Infrared (NIR) light reflection from birth up to 2 years
Secondary ID [1] 287965 0
OPP1111820
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 296879 0
Condition category
Condition code
Diet and Nutrition 297110 297110 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 297122 297122 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a cross-sectional validation study recruiting infants and children from birth up to 2 years of age.

The intervention device is using: Near-Infrared (NIR) light reflection.

The NIR hand held device will be measured through the skin's surface on 4 anatomical locations; triceps, subscapular, mid-thigh and flank for approximately 30 seconds performed by a research assistant or nurse. The infants / children will be seen at one single point in time at either birth (within 48 hours), 3 months, 6 months, 12 months, 18 months or 24 months of age following recruitment.
Intervention code [1] 293337 0
Early detection / Screening
Intervention code [2] 293350 0
Prevention
Comparator / control treatment
The Near-Infrared (NIR) light reflection device will be compared against a range of criteria with reference to a gold standard which include:

Air displacement plethysmography (ADP) / Pea Pod involves measurement of the infant weight on a scale followed by the infant being placed inside a warmed compartment with fresh air to measure body volume, this test takes 2 minutes.

Dual-energy X-ray Absorptiometry (DXA) involves the infant lying flat on a scanner bed to measure total Body % Fat and Bone Mineral Content (BMC), this test takes 3 minutes

Deuterium dilution to measure Total Body Water (TBW) involves firstly taking a basal saliva sample before the deuterium oxide dose is given, 1ml of deuterium oxide (D2O, 99.8 atom % 2H) is administered using an oral syringe; saliva samples are collected up to 3 hours after the dose was consumed.

Ultrasound involves moving a ultrasound transducer over the skin to measure the thickness of subcutaneous fat at two anatomical sites; thigh and abdomen, this test takes 10 minutes.

Anthropometry including; weight using electronic scales, length/height using a infantometer /stadiometer, head, abdomen, thigh and arm circumferences using a metal tape measure and skinfold measurements using hand-held callipers at 4 anatomical locations; triceps, subscapular, mid-thigh and flank . Anthropometry testing will take approximately 30 minutes.

The 3-Compartment Model will be used to measure body composition which requires determination of TBW, body mass, body volume and BMC and is classified as a reference technique.

The infants / children will be seen at one single point in time at either birth (within 48 hours), 3 months, 6 months, 12 months, 18 months or 24 months of age following recruitment.

The newborns that are eligible (within 48 hours after birth) will have the following measurements: DXA, NIR light reflection, ADP / Pea Pod , ultrasound and anthropometry performed by a research assistant / nurse.

Any infant / child who are 3 months or older will have the following procedures: DXA, NIR, Deuterium dilution, anthropometry, ultrasound performed by a research assistant / nurse.
Control group
Active

Outcomes
Primary outcome [1] 296723 0
To investigate the level of correlation between the 3-compartment model and the NIR body composition result
Timepoint [1] 296723 0
Assessed at a single study visit following recruitment at either age; birth (within 48 hours) 3, 6, 12, 18 or 24 months
Secondary outcome [1] 319199 0
To investigate the level of correlation between subcutaneous fat thickness assessed by ultrasound and the NIR body composition result.
Timepoint [1] 319199 0
Assessed at single study visit following recruitment at either birth (within first 48 hours), 3, 6, 12, 18 or 24 months
Secondary outcome [2] 319275 0
To investigate the level of correlation between anthropometric variables and the NIR body composition result.
Timepoint [2] 319275 0
Assessed at single study visit following recruitment at either birth (within first 48 hours), 3, 6, 12, 18 or 24 months

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
1. Written parental informed consent
2. Term gestational age (GA) (=>37+0 – 41+6 weeks GA)
3. =<2 years (24 months) of age
4. Black African or Indian ethnicity
5. Mother >18 years old age
6. Singleton pregnancy
7. Mother lives within the study area
8. Can read and understand English
Minimum age
6 Hours
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
EXCLUSION CRITERIA
1. Any maternal condition or impairment with inability to give parental informed consent
2. Neonates: Prematurity (=<36+6 weeks GA) and/ or the presence of any major congenital anomalies or morbidity that may contraindicate the neonatal body composition measurements
3. Infants and/or children: Birth defect (congenital anomalies, preterm birth (=<36+6 weeks GA)
4. Physical or intellectual disability in infants and /or children, influencing physical activity or food habits
5. Chronic health problem in infants and / or children, influencing weight and length
6. If currently enrolled in any other research / clinical study
7. If any DXA scans completed in the past 12 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
SAMPLE SIZE

The sample size is based on a true mean difference between BF% measured by a reference method (TBW and / or ADP and DXA) and BF% measured by NIR using a mean difference of 2.0 BF% with a standard deviation of 3.0 BF%, at a significance level of 0.05 with 80% power (1), a sample size of 28 infants and / or children at each age point are required to complete all aspects of the study. Thus with an expected non-compliance rate based on previous studies by Fields et al (1), we estimate the total number required would approximately ~ 720 in total to evaluate the accuracy, precision, bias, and reliability of the NIR device across 6 age groups (birth, 3, 6, 12,18,24 months).

STATISTICAL METHODS / ANALYSIS

For validation purposes, Pearson’s correlation coefficients will be used to describe the associations between NIR against the 3 compartment model and /or ultrasound measurements. Coefficient of determination or R2 will be used to assess the best prediction equation and minimum wavelength for NIR body composition assessment.

Multiple and logistic regression will be used to analyse the relationship with anthropometric factors including circumferences and skinfolds.

For prediction of under and over nutrition positive and negative predictive values (PPV and NPV) and the sensitivity, specificity, and likelihood ratios with 95% confidence intervals. Receiver Operating Characteristic (ROC) curves will be used along with the ease of use, cost and portability of each method to determine the most appropriate tool for determining body composition.

REFERENCES

1. Fields DA, Allison DB. Air-Displacement Plethysmography Pediatric Option in 2–6 Years Old Using the Four-Compartment Model as a Criterion Method. Obesity. 2012;20(8):1732-7.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
4/04/2016
Date of last participant enrolment
Anticipated
1/02/2017
Actual
23/12/2016
Date of last data collection
Anticipated
28/12/2018
Actual
Sample size
Target
720
Accrual to date
Final
650
Recruitment outside Australia
Country [1] 7377 0
South Africa
State/province [1] 7377 0
Johannesburg, Gauteng province

Funding & Sponsors
Funding source category [1] 292460 0
Charities/Societies/Foundations
Name [1] 292460 0
Bill and Melinda Gates Foundation
Country [1] 292460 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
New South Wales, 2006
Country
Australia
Secondary sponsor category [1] 291160 0
None
Name [1] 291160 0
N/A
Address [1] 291160 0
N/A
Country [1] 291160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293923 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293923 0
Ethics committee country [1] 293923 0
Australia
Date submitted for ethics approval [1] 293923 0
06/07/2015
Approval date [1] 293923 0
10/11/2015
Ethics approval number [1] 293923 0
2015/595

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 651 651 0 0
/AnzctrAttachments/369668-University of Sydney_Approval Letter 2015_595_10th November 2015.pdf
Attachments [2] 1017 1017 0 0
/AnzctrAttachments/369668-V1.4_Research Protocol_18032016_clean.pdf (Protocol)

Contacts
Principal investigator
Name 61730 0
Dr Alistair McEwan
Address 61730 0
Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006
Country 61730 0
Australia
Phone 61730 0
+61 2 9351 7256
Fax 61730 0
+61 2 9351 3847
Email 61730 0
alistair.mcewan@sydney.edu.au
Contact person for public queries
Name 61731 0
Alistair McEwan
Address 61731 0
Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006
Country 61731 0
Australia
Phone 61731 0
+61 2 9351 7256
Fax 61731 0
+61 2 9351 3847
Email 61731 0
alistair.mcewan@sydney.edu.au
Contact person for scientific queries
Name 61732 0
Alistair McEwan
Address 61732 0
Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006
Country 61732 0
Australia
Phone 61732 0
+61 2 9351 7256
Fax 61732 0
+61 2 9351 3847
Email 61732 0
alistair.mcewan@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applicable to this type of study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIModel Development for Fat Mass Assessment Using Near-Infrared Reflectance in South African Infants and Young Children Aged 3–24 Months2021https://doi.org/10.3390/s21062028
N.B. These documents automatically identified may not have been verified by the study sponsor.