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NCT Number: NCT06287697

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

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.

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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Nutrition, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • FAO
  • Faculty of Medicine, University of Ruhuna, Sri Lanka
  • Food and Nutrition Research Institute, Philippines
  • International Atomic Energy Agency
  • National Institute of Nutrition, Vietnam
  • Pakistan Institute of Nuclear Science and Technology (PINSTECH)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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