Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia

February 29, 2024 updated by: Tippawan Pongcharoen, Mahidol University

Determination of Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia Using the Doubly-Labelled Water (DLW) Technique

This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

Study Overview

Detailed Description

The current international recommendations on energy requirements for children aged 6-24 months were established based on data from the Western populations. More human data of healthy children from the developing countries where the living conditions may not be as favourable for child growth and development would be needed to ascertain the validity of the global recommendation. The role of the doubly-labelled water (DLW) technique in measuring total daily energy expenditure to derive energy requirements for humans was also highlighted. Low and middle income countries in Asian countries have undergone the nutrition transition and malnutrition on both ends of the spectrum emerge as significant nutrition challenges during this critical period of growth. Unfortunately, data on body composition, i.e., the relative amounts of fat and lean or fat-free tissue which constitutes quality normal growth beyond anthropometric measurements are scarce. These data will also be needed to guide the infant and young child feeding (IYCF) recommendations for good nutrition and health and to prevent all forms of malnutrition in the region.

This project addressed the need to fill the information gap for the region, and potentially be included for making revision on energy requirement recommendations for infants and young children (IYC) for Asia and beyond. Building on the previous technical cooperation between institutions in Southeast and South Asia with the International Atomic Energy Agency (IAEA) on stable isotopic techniques for health and nutrition well-being, this project is a collaboration between IAEA, FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

Study Type

Observational

Enrollment (Actual)

391

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nakhon Pathom
      • Salaya, Nakhon Pathom, Thailand, 73170
        • Institute of Nutrition, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Apparently healthy infants and young children aged 6-23 months of both sexes, belonging to the major ethnicity of the country, and having any socio-economic status.

Description

Inclusion Criteria for Mothers:

  • Being aged >18 y old
  • Being non-smoker
  • Gestational age at delivery 37-41weeks
  • Belonging to the major ethnicity of the country
  • Having any socio-economic status
  • Willing to sign informed written consent

Inclusion Criteria for Infants:

  • Healthy baby
  • Full term
  • Having birth weight between 2.5 and 4.0 kg
  • Height-for-age Z score and weight-for-height Z score at or above -2SD
  • Being exclusively or predominantly breast-fed for at least 3 months

Exclusion Criteria for Mothers:

  • Mothers: having chronic diseases, e.g., gestational diabetes were excluded.

Exclusion Criteria for Infants:

  • Having inborn errors or chronic diseases e.g., celiac diseases
  • Taking special supplement, e.g., RUTF.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Longitudinal study-Thailand

Cohort 1: 60 children were started at 6-8 months old, and were followed-up at 9-11, 12-14 and 15-17 months old.

Cohort 2: 71 children were started at 12-14 months old, were followed-up 15-17, 18-21 and 21-24 months old.

No intervention
Cross-sectional study-Pakistan
Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
No intervention
Cross-sectional study-Philippines
Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
No intervention
Cross-sectional study-Sri Lanka
Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
No intervention
Cross-sectional study-Vietnam
Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Energy Expenditure
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Total Energy Expenditure assessed using doubly labelled water (DLW) technique
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Body composition
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Body composition assessed using doubly labelled water (DLW) technique
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Body weight of infants in kilograms
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Length
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Lenght of infants in centimeters
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Head circumference
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Head circumference of infants in centimeters
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Mid-upper arm circumference
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Mid-upper arm circumference of the left arm in centimeters
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Triceps skinfold thickness
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Triceps skinfold thickness of the left arm in millimeters
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Subscapular skinfold thickness
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Subscapular skinfold thickness of the left side in millimeters
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Infant and Young Child Feeding (IYCF)
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
IYCF indicators were determined using the IYCF questionnaire IYCF practices were assessed using the IYCF , breast milk intake, dietary intake
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Dietary intake
Time Frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
24-hr recall was administered for 3 days to obtain nutrient intakes from breast milk and diet
assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IAEA repository upon approval

IPD Sharing Time Frame

2025 onward

IPD Sharing Access Criteria

Upon approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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