- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06287697
Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nakhon Pathom
-
Salaya, Nakhon Pathom, Thailand, 73170
- Institute of Nutrition, Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Tippawan Pongcharoen, PhD, Mahidol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LOA/RAP/2019/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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