ANZCTR - Registration

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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 information initially 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]

OPP1111820

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malnutrition

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

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]

Early detection / Screening

Intervention code [2]

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]

To investigate the level of correlation between the 3-compartment model and the NIR body composition result

Timepoint [1]

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]

To investigate the level of correlation between subcutaneous fat thickness assessed by ultrasound and the NIR body composition result.

Timepoint [1]

Assessed at single study visit following recruitment at either birth (within first 48 hours), 3, 6, 12, 18 or 24 months

Secondary outcome [2]

To investigate the level of correlation between anthropometric variables and the NIR body composition result.

Timepoint [2]

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]

South Africa

State/province [1]

Johannesburg, Gauteng province

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Bill and Melinda Gates Foundation

Address [1]

440 5th Ave N.
Seattle, WA 9810
Washington, United States

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

University of Sydney Human Research Ethics Committee
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/07/2015

Approval date [1]

10/11/2015

Ethics approval number [1]

2015/595

Summary

Brief summary

Globally there are millions of under-five who are stunted (162M), underweight (99M), wasted (51M) or overweight (44M). The timing of child malnutrition reveals a 1,000 day period for meaningful intervention – before/during pregnancy, immediately following birth and up to 2 years of age - if the immediate effects on health and child mortality and the life-long impact of early onset adult disease are to be prevented.

Assessment of body composition is vital to deliver improved nutritional management of under and over nourished infants & children. However, there is a lack of convenient, accurate and low cost devices for direct monitoring of nutritional status. This leads to difficulties for health workers to identify undernourished and overnourished infants and children and in monitoring changes in nutritional status following interventions.

Our aim is to produce a suitable low-cost portable device using Near-Infrared (NIR) light reflection for direct monitoring of nutritional status from birth to two years of age. Using a cross-sectional design this study aims to validate Near-Infrared (NIR) light reflection against a range of criteria with reference to a gold standard from birth up to 2 years.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/369668-University of Sydney_Approval Letter 2015_595_10th November 2015.pdf

Attachments [2]

/AnzctrAttachments/369668-V1.4_Research Protocol_18032016_clean.pdf (Protocol)

Contacts

Principal investigator

Name

Dr Alistair McEwan

Address

Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006

Country

Australia

Phone

+61 2 9351 7256

Fax

+61 2 9351 3847

[email protected]

Contact person for public queries

Name

Dr Alistair McEwan

Address

Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006

Country

Australia

Phone

+61 2 9351 7256

Fax

+61 2 9351 3847

[email protected]

Contact person for scientific queries

Name

Dr Alistair McEwan

Address

Rm 850, School of Electrical and Information Engineering, J03
The University of Sydney
NSW, 2006

Country

Australia

Phone

+61 2 9351 7256

Fax

+61 2 9351 3847

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No		J. Huvanandana, P. Jones, H. E. Jeffery, A. E. Car... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Model Development for Fat Mass Assessment Using Near-Infrared Reflectance in South African Infants and Young Children Aged 3–24 Months	2021	https://doi.org/10.3390/s21062028

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically