NCT01920724

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

July 13, 2013

Last Update Submit

February 2, 2023

Conditions

Keywords

Preschool childrenBody composition

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Body fatness

    4 months

Secondary Outcomes (1)

  • Nutrient intake

    4 months

Study Arms (1)

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).

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Healthy children
  • Aged 3-5 years
  • BMI or HAZ fall in the study protocol

You may not qualify if:

  • Chronic diseases
  • Ongoing medical treatments likely to affect body composition
  • Malformation or muscle diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

ObesityCachexia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesThinness

Study Officials

  • Tippawan Pongcharoen, Ph.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2013

First Posted

August 12, 2013

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations