Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia (NCT06287697) | Clinical Trial Compass
UnknownNot Applicable
Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia
Thailand391 participantsStarted 2020-01-21
Plain-language 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.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Energy Expenditure
Timeframe: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
2
Body composition
Timeframe: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months