Clinical trial NCT01979770: Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes
Official title: Association of Early Life Nutritional Related Exposures and Long-term Health and Cognitive Development Outcomes in Adolescents in Northeast, Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overnutrition
Undernutrition
Keywords: Adolescent
Nutritional status
Body composition
Biochemical status
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 529
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents who participated in an intervention trial of iron and zinc supplementation and a follow-up study at 9 years of age in 3 rural districts in Khon Kaen province, northeast of Thailand.

Brief summary: This study aims to investigate the relationship of the various exposures during infancy and childhood on later health and development of adolescents. Various exposures to be assessed include, but not limit to, nutritional status, body composition, energy expenditure, dietary intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.

The study will specifically aim to respond these research questions:

1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2 What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are the factors associated with cognitive functioning during adolescence? Since numerous variables were collected, additional research questions can be possibly studied or other interested variables can be included in the future.

Detailed description: A longitudinal data were collected in children in the northeast of Thailand beginning at 4-6 months of age and every 2 months through 10-12 months of age while children had been given iron and/or zinc supplementation. Biochemical, anthropometric, socio-demographic, feeding practices, and maternal characteristics data were collected. Children were followed up at 9 years of age to assess the long-term consequences of supplementation and early life nutrition on cognitive functioning and growth. There is a need to continue the follow-up of this study in order to address the association between early nutritional exposures and risks of cardio-metabolic dysfunction and cognitive and behavioral development later in childhood, adolescence and adulthood. Thus, we propose to follow-up these children during adolescence to assess the relationship of early life nutrition and exposures during infancy and childhood and outcomes including nutritional status, cognitive functioning, and risk for non-communicable diseases (NCDs). Findings from this study could provide awareness and information in developing policies and timely interventions to maintain optimal nutritional status throughout vulnerable life stages and reduce risks of NCDs and disabilities later in life.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy children

Exclusion Criteria:

* none

Primary outcomes:
measure: Body composition
timeFrame: 1 year
Secondary outcomes:
measure: Cognition
timeFrame: 1 year
Other outcomes:
measure: Cardio-vascular fitness
timeFrame: 1 year
Locations:
city: Salaya
country: Thailand
facility: Institute of Nutrition, Mahidol University
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Tippawan Pongcharoen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: