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Energy ExpenditureNCT06287697

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

An observational study of Energy Expenditure and Body Composition, run by Mahidol University at 1 site in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 24 monthsHealthy volunteers can take part
How many people
391 participants
Where
1 siteThailand
Study dates
21 Jan 2020to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Mothers: having chronic diseases, e.g., gestational diabetes were excluded.
  • Having inborn errors or chronic diseases e.g., celiac diseases
  • Taking special supplement, e.g., RUTF.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Institute of Nutrition, Mahidol University

    Salaya, Changwat Nakhon Pathom, 73170

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
No intervention
Keywords
Total energy expenditure, Fat mass, Fat-free mass, Doubly-labelled water, Children aged 6-24 months, Infant and young child feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT06287697
Study groupRoleWhat they receive
Longitudinal study-ThailandCohort 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.
Receives: Other: No intervention
Cross-sectional study-PakistanChildren aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
Receives: Other: No intervention
Cross-sectional study-PhilippinesChildren aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
Receives: Other: No intervention
Cross-sectional study-Sri LankaChildren aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
Receives: Other: No intervention
Cross-sectional study-VietnamChildren aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Energy Expenditure

    Total Energy Expenditure assessed using doubly labelled water (DLW) technique

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  2. Body composition

    Body composition assessed using doubly labelled water (DLW) technique

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Secondary outcomes (8)

  1. Weight

    Body weight of infants in kilograms

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  2. Length

    Lenght of infants in centimeters

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  3. Head circumference

    Head circumference of infants in centimeters

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  4. Mid-upper arm circumference

    Mid-upper arm circumference of the left arm in centimeters

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  5. Triceps skinfold thickness

    Triceps skinfold thickness of the left arm in millimeters

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  6. Subscapular skinfold thickness

    Subscapular skinfold thickness of the left side in millimeters

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  7. Infant and Young Child Feeding (IYCF)

    IYCF indicators were determined using the IYCF questionnaire IYCF practices were assessed using the IYCF , breast milk intake, dietary intake

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

  8. Dietary intake

    24-hr recall was administered for 3 days to obtain nutrient intakes from breast milk and diet

    Measured: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start21 Jan 2020
  3. Primary completion31 Oct 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
391 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287697
Sponsor's protocol ID
LOA/RAP/2019/20
Status last verified
Aug 2026
First submitted
11 Jan 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: IAEA repository upon approval

Publications

  • Ua-Areechit T, Suteerojntrakool O, Pongcharoen T, Winichagoon P, Judprasong K, Murphy-Alford AJ, Lee WTK, Potip B, Sridonpai P, Tongchom W, Chomtho S. Breastfeeding duration is associated with higher adiposity at 6-8 months of age. Matern Child Nutr. 2023 Jan;19(1):e13438. doi: 10.1111/mcn.13438. Epub 2022 Oct 18.

    PubMed 36254499

Questions about this trial

What is this clinical trial studying?

An observational study of Energy Expenditure and Body Composition, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Energy Expenditure (time frame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06287697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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