OvernutritionNCT01979770
Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes
An observational study of Overnutrition and Undernutrition, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Overnutrition, Undernutrition
- How many people
- 529 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2013to 21 Mar 2018
- 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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Apparently healthy children
Who cannot join
- none
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: Association of Early Life Nutritional Related Exposures and Long-term Health and Cognitive Development Outcomes in Adolescents in Northeast, Thailand
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.
Read the 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.
- Conditions
- Overnutrition, Undernutrition
- Keywords
- Adolescent, Nutritional status, Body composition, Biochemical status
- Medical subject headings
- Overnutrition, Malnutrition
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 |
|---|---|---|
| Adolescents | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body fat mass (kg), Body fat-free mass (kg) % body fat mass (%), % body fat-free mass (%)
Measured: 1 year
Secondary outcomes (1)
Cognition
IQ scores (IQ point)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start1 Jan 2013
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvernutritionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tippawan Pongcharoen, Mahidol University
- Investigators
- Tippawan Pongcharoen, Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979770
- Sponsor's protocol ID
- MU-IRB2012/109.1611
- Other IDs
- COA 2013/008.1501
- Status last verified
- Jan 2023
- First submitted
- 28 Jul 2013
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Early Life Nutritional Related Exposures and Long-term Health and Cognitive Development Outcomes in Adolescents in Northeast, Thailand
- ClinicalTrials.gov ID
- NCT01979770
- Acronym / sponsor ID
- MU-IRB2012/109.1611
- Conditions
- Overnutrition, Undernutrition
- Keywords
- Adolescent, Nutritional status, Body composition, Biochemical status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 8 Nov 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –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. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Apparently healthy children
Key exclusion criteria (1 listed)
- none
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: 1 year
Body fat mass (kg), Body fat-free mass (kg) % body fat mass (%), % body fat-free mass (%)
1 secondary outcome
Cognition
Time frame: 1 year
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 31 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Overnutrition
Active, not recruitingPhase 2
A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Obesity, Overweight and/or Obesity
Not yet recruitingPhase 2
A Study to Investigate the Effect of LY4086940 Versus Placebo in Participants With Obesity or Overweight and Without Type 2 Diabetes
Obesity, Overweight
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Obesity, Overweight and/or Obesity
Active, not recruitingPhase 3
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
Osteoarthritis
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 Overnutrition and Undernutrition, 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 1 inclusion and 1 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 31 Jan 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: 1 year). 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 31 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.