ObesityNCT01920724
Body Composition in Preschool Children
An observational study of Obesity and Wasting, run by Mahidol University at 1 site in Thailand.
Trial summary
Thailand has been facing with the double burden of malnutrition. Many studies in Thailand, which aim to explore the situation, causes, and strategies to prevent obesity, have focused on adults, adolescents, or school-aged children. Few studies have been conducted in preschool children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- How many people
- 137 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2010to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children in the daycare centers in Nakhon Pathom and Samut Prakarn porvinces will be screened and categorized into 4 groups, including wasting (BMI for age Z-scores < -2 SD), normal (-1 SD ≤ BMI for age Z-scores ≤ +1 SD), obesity (BMI for age Z-scores > +2 SD), and stunting (HAZ < -2 SD). Then, they will be randomly selected to participate in this study.
Who may be able to join
- Healthy children
- Aged 3-5 years
- BMI or HAZ fall in the study protocol
Who cannot join
- Chronic diseases
- Ongoing medical treatments likely to affect body composition
- Malformation or muscle diseases
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of Nutrition, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Body Composition and Dietary Intake in Preschool Children Aged 3-5 Years in Daycare Centers
Thailand has been facing with the double burden of malnutrition. Many studies in Thailand, which aim to explore the situation, causes, and strategies to prevent obesity, have focused on adults, adolescents, or school-aged children. Few studies have been conducted in preschool children. Obesity or stunting during childhood increases the risk of being obesity in adulthood and leads to chronic diseases. If obesity is established in adulthood, it is difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young children should be highly considered. Study of dietary pattern and reliable field methods to measure fat mass (FM) in children may partly contribute to primary prevention of childhood obesity. The deuterium dilution technique is an accurate and suitable method for children and population-based studies. However, it has not been widely used in children in Thailand. Hence, this study aimed to utilize the deuterium dilution technique for assessing body composition and to determine the quality and quantity of dietary intake among children 3-5 years of age with different nutritional status. We conducted a cross-sectional study in 15 daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were purposively selected according to their nutritional status: stunted, thin, normal, and overweight/obese. Anthropometric measurements were conducted. Body composition was determined based on total body water using deuterium dilution technique. Dietary intake data were obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have more fat mass compared to the normal children.
Read the detailed description
Body composition of the children was assessed using the deuterium technique. Total body water (TBW) content was calculated. Then, fat free mass (FFM) and fat mass (FM) was calculated.
Weight and height of all children were using a standard technique. Body mass index and nutritional status was calculated using World Health Organization (WHO) growth standard for children 0-5 years.
Dietary intake of children was assessed using 2 non-consecutive 24 hour dietary recalls. The 1st and 2nd recall was about 2 weeks apart. Nutrient intake was calculated using the INMUCAL-Nutrients WD. 4.0 (Institute of Nutrition, 2010).
- Keywords
- Preschool children, Body composition
- Medical subject headings
- Obesity, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| wasting, obesity, stunting, normal | wasting (BMI for age Z-scores < -2 SD), normal (-1 SD ≤ BMI for age Z-scores ≤ +1 SD), obesity (BMI for age Z-scores > +2 SD), and stunting (HAZ < -2 SD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body fatness
Measured: 4 months
Secondary outcomes (1)
Nutrient intake
24 hr recall was perform on a weekend day and a weekday day and nutrient intake was calculated.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Tippawan Pongcharoen, Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920724
- Sponsor's protocol ID
- MU-IRB 2010/211.0807
- Other IDs
- A09/2554
- Status last verified
- Feb 2023
- First submitted
- 13 Jul 2013
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Dietary Intake in Preschool Children Aged 3-5 Years in Daycare Centers
- ClinicalTrials.gov ID
- NCT01920724
- Acronym / sponsor ID
- MU-IRB 2010/211.0807
- Keywords
- Preschool children, Body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thailand has been facing with the double burden of malnutrition. Many studies in Thailand, which aim to explore the situation, causes, and strategies to prevent obesity, have focused on adults, adolescents, or school-aged children. Few studies have been conducted in preschool children. Obesity or stunting during childhood increases the risk of being obesity in adulthood and leads to chronic diseases. If obesity is established in adulthood, it is difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young children should be highly considered. Study of dietary pattern and reliable field methods to measure fat mass (FM) in children may partly contribute to primary prevention of childhood obesity. The deuterium dilution technique is an accurate and suitable method for children and population-based studies. However, it has not been widely used in children in Thailand. Hence, this study aimed to utilize the deuterium dilution technique for assessing body composition and to determine the quality and quantity of dietary intake among children 3-5 years of age with different nutritional status. We conducted a cross-sectional study in 15 daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were purposively selected according to their nutritional status: stunted, thin, normal, and overweight/obese. Anthropometric measurements were conducted. Body composition was determined based on total body water using deuterium dilution technique. Dietary intake data were obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have more fat mass compared to the normal children.
Detailed description
Body composition of the children was assessed using the deuterium technique. Total body water (TBW) content was calculated. Then, fat free mass (FFM) and fat mass (FM) was calculated.
Weight and height of all children were using a standard technique. Body mass index and nutritional status was calculated using World Health Organization (WHO) growth standard for children 0-5 years.
Dietary intake of children was assessed using 2 non-consecutive 24 hour dietary recalls. The 1st and 2nd recall was about 2 weeks apart. Nutrient intake was calculated using the INMUCAL-Nutrients WD. 4.0 (Institute of Nutrition, 2010).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wasting, obesity, stunting, normal | – | –wasting (BMI for age Z-scores < -2 SD), normal (-1 SD ≤ BMI for age Z-scores ≤ +1 SD), obesity (BMI for age Z-scores > +2 SD), and stunting (HAZ < -2 SD). |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children in the daycare centers in Nakhon Pathom and Samut Prakarn porvinces will be screened and categorized into 4 groups, including wasting (BMI for age Z-scores < -2 SD), normal (-1 SD ≤ BMI for age Z-scores ≤ +1 SD), obesity (BMI for age Z-scores > +2 SD), and stunting (HAZ < -2 SD). Then, they will be randomly selected to participate in this study.
Key inclusion criteria (3 listed)
- Healthy children
- Aged 3-5 years
- BMI or HAZ fall in the study protocol
Key exclusion criteria (3 listed)
- Chronic diseases
- Ongoing medical treatments likely to affect body composition
- Malformation or muscle diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition
Time frame: 4 months
Body fatness
1 secondary outcome
Nutrient intake
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Introduction to body composition assessmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tippawan Pongcharoen, Ph.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Wasting, 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 3 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: finished, as of the sponsor's last update on 3 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body composition (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.