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

NCT06287697 | Active Not Recruiting

• 1 other identifier: LOA/RAP/2019/20
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Energy Expenditure; Body Composition; Infants and Young Children; Infant and Young Child Feeding

Keywords

Total energy expenditure; Fat mass; Fat-free mass; Doubly-labelled water; Children aged 6-24 months; Infant and young child feeding

Outcome Measures

Primary Outcomes (2)

• Total Energy Expenditure

  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

  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 Outcomes (8)

• Weight

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

• Length

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

• Head circumference

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

• Mid-upper arm circumference

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

• Triceps skinfold thickness

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

Study Arms (5)

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.

Other: No intervention

Cross-sectional study-Pakistan

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

Other: No intervention

Cross-sectional study-Philippines

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

Other: No intervention

Cross-sectional study-Sri Lanka

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

Other: No intervention

Cross-sectional study-Vietnam

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Cross-sectional study-Pakistan; Cross-sectional study-Philippines; Cross-sectional study-Sri Lanka; Cross-sectional study-Vietnam; Longitudinal study-Thailand

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Nutrition, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (1)

• 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.

  PMID: 36254499 RESULT

Study Officials

• Tippawan Pongcharoen, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: March 1, 2024
• Study Start: January 21, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2025 onward
• Access Criteria: Upon approval

Locations

TH (1)