StuntingNCT03364426
Characterisation and Sociodemographic Determinants of Stunting Among Malaysian Children Aged 6-19 Years
An observational study of Stunting, run by Manjinder Sandhu.
Trial summary
Child stunting remains an important global health issue, with 157 million children under five years of age estimated to be stunted in 2014. Until recently, stunting was thought to occur in the first 1000 days of life (between conception and 2 years of life), and was thought to be largely irreversible thereafter. Read more about this study
- Who is it for?
- Ages 6 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- How many people
- 6,759 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2012to 23 Sep 2014
- 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 6 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study is based on existing observational data collected by the the South East Asia Community Observatory (SEACO), a health and demographic surveillance system (HDSS) covering approximately 45 000 individuals in Segamat, Malaysia. The HDSS regularly (annually) enumerates all consenting households and individuals within its catchment area, and has also conducted a health survey to date during which basic sociodemographic, lifestyle-related and anthropometric data were collected from individuals aged 6 years and above. Further information on the SEACO HDSS can be found at: https://academic.oup.com/ije/article/46/5/1370/4037470.This study uses cross-sectional data on children aged 6-19 years, collected between 2012-2014.
Who may be able to join
- Age >= 6 years and <= 19 years
- Whether or not the potential participant has information on all exposure and outcome variables of interest.
Who cannot join
None listed.
About this study
Child stunting remains an important global health issue, with 157 million children under five years of age estimated to be stunted in 2014. Until recently, stunting was thought to occur in the first 1000 days of life (between conception and 2 years of life), and was thought to be largely irreversible thereafter. However, emerging research suggests that children can transition between stunted and non stunted status up to 15 years of age, with studies also suggesting potential implications in terms of cognitive status. Despite this, there is little research on stunting and its potential determinants among children of older ages, with most current studies confined to those under five. This study aims to assess the prevalence of stunting and examine potential sociodemographic determinants of stunting (including individual, maternal and household level indices) among older children (aged 6-19 years) in a Malaysian population.
Read the detailed description
This analysis is based on existing data collected by a health and demographic surveillance system operating in Segamat, Malaysia, and data for all individuals meeting the stated inclusion criteria are used in the study.
There is not a specific control treatment in this study. Rather, we calculate the risk of stunting associated with (1) a unit increase in each exposure, or (2) categories of exposure with respect to a referent category. Specifically, for the primary exposures as listed above:
- Age: risk per year increase
- Sex: risk in girls versus boys (referent)
- Ethnicity: risk in (1) Indian, (2) Chinese, (3) Indigenous or (4) Other ethnicity, versus Malay (referent)
- BMI-for-age status: risk in (1) underweight or (2) overweight, versus normal weight (referent)
- Birth order: risk in children of second, third and fourth or higher birth order, versus first born (referent)
- Maternal height: risk in children of mothers with height 155-159cm, 150-154cm, 145-149cm, and <145cm, versus those with height 160cm or higher (referent)
- Maternal current underweight: risk in children of mothers with BMI <18.5 kg/m2, versus those with BMI >=18.5 kg/m2 (referent)
- Rooms (bedrooms, bathrooms, living areas) per household member: risk per unit increase in room to person ratio for each room type
- Type of toilet: risk among children in households with (1) Bore hole toilet, (2) Pour flush toilet, (3) Flush toilet with septic tank, (4) Flush toilet connected with sewerage system, versus those living in households with none, bucket or hanging latrine (referent)
- Toilet shared with other household (yes/no): risk among children in households with a shared toilet, versus those living in households without one
- Main source of drinking water: risk among children in households using water from (1) Public standpipe or other protected source, (2) Piped into yard, (3) Piped into house, versus those living in households using an unprotected source (referent)
- Main method of garbage disposal: risk among children in households having their garbage (1) Collected and thrown for recycling, (2) Collected irregularly by local authority, (3) Collected regularly by local authority, versus in those in households where garbage is buried, burned or thrown (referent)
Methods for crude analysis and gaining an introductory sense of the data include examination of variable distributions and clustering of the outcome variable of interest (stunting or height-for-age). Exposure variables are assessed by stunting status; differences between stunted and non-stunted groups are assessed using Student's t test for continuous variables, and Pearson's chi squared test (Fisher's exact test for variables with cell counts <5) for categorical variables. Additionally, the classification and prevalence of stunting is assessed using two different references: the World Health 2007 reference and Centers for Disease Control and Prevention 2000 reference; agreement in classification between the two is calculated using Cohen's kappa.
The primary method of analysis is mixed effects Poisson regression, with stunting as the outcome of interest. Final models include all exposure variables of interest, in order to assess any independent associations between each exposure and stunting risk. All models are adjusted for clustering at the household level.
A number of secondary analyses are used in order to check the robustness and specificity of associations. These include:
- Adding maternal age as a covariate in models, examining associations of maternal age with stunting, and the effect of its addition on other associations
- Adding in maternal education, paternal education or head of household's education, and assessing subsequent effects as described in (1)
- Adding in paternal height, and assessing subsequent effects as described in (1)
- Adding in a number of theoretically uncorrelated variables to test the specificity of associations, and assessing subsequent effects as described in (1)
- Using mixed effects linear regression, with height-for-age z-score as the outcome of interest. Final models include all exposure variables of interest, in order to assess any independent associations between each exposure and stunting risk. All models are adjusted for clustering at the household level.
Both the primary and secondary analyses are run with stunting or height-for-age expressed according to (1) the Centers for Disease Control and Prevention 2000 reference and (2) the World Health Organization 2007 reference.
- Conditions
- Stunting
- Being tested
- No intervention
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention - this is was an observational, cross-sectional study to identify potential risk factors associated with stunting
What is being measured
The primary outcome is the main question the study is designed to answer.
Child stunting
Stunting was expressed using the Centers for Disease Control and Prevention 2000, and the World Health Organization 2007 references.
Measured: This was a one-time measurement, taken during a survey.
Secondary outcomes (1)
Child height-for-age
Height-for-age z-score was expressed using the Centers for Disease Control and Prevention 2000, and the World Health Organization 2007 references. (Same measure as above, but expressed as a continuous rather than categorical variable).
Measured: This was a one-time measurement, taken during a survey (as above).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start12 Apr 2012
- Primary completion23 Sep 2014
- Study completion23 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies 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
- 6,759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manjinder Sandhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manjinder Sandhu, University of Cambridge
- Investigators
- Daniel D Reidpath, PhD, Principal investigator, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364426
- Sponsor's protocol ID
- U1111-1203-0963
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Partap U, Young EH, Allotey P, Soyiri IN, Jahan N, Komahan K, Devarajan N, Sandhu MS, Reidpath DD. HDSS Profile: The South East Asia Community Observatory Health and Demographic Surveillance System (SEACO HDSS). Int J Epidemiol. 2017 Oct 1;46(5):1370-1371g. doi: 10.1093/ije/dyx113. No abstract available.
PubMed 29024948
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation and Sociodemographic Determinants of Stunting Among Malaysian Children Aged 6-19 Years
- ClinicalTrials.gov ID
- NCT03364426
- Acronym / sponsor ID
- U1111-1203-0963
- Conditions
- Stunting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,759 participants (actual)
- Lead sponsor
- Manjinder SandhuUniversity, hospital or other
- Study start
- 12 Apr 2012 (actual)
- Primary completion
- 23 Sep 2014 (actual)
- Study completion
- 23 Sep 2014 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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.
Child stunting remains an important global health issue, with 157 million children under five years of age estimated to be stunted in 2014. Until recently, stunting was thought to occur in the first 1000 days of life (between conception and 2 years of life), and was thought to be largely irreversible thereafter. However, emerging research suggests that children can transition between stunted and non stunted status up to 15 years of age, with studies also suggesting potential implications in terms of cognitive status. Despite this, there is little research on stunting and its potential determinants among children of older ages, with most current studies confined to those under five. This study aims to assess the prevalence of stunting and examine potential sociodemographic determinants of stunting (including individual, maternal and household level indices) among older children (aged 6-19 years) in a Malaysian population.
Detailed description
This analysis is based on existing data collected by a health and demographic surveillance system operating in Segamat, Malaysia, and data for all individuals meeting the stated inclusion criteria are used in the study.
There is not a specific control treatment in this study. Rather, we calculate the risk of stunting associated with (1) a unit increase in each exposure, or (2) categories of exposure with respect to a referent category. Specifically, for the primary exposures as listed above:
- Age: risk per year increase
- Sex: risk in girls versus boys (referent)
- Ethnicity: risk in (1) Indian, (2) Chinese, (3) Indigenous or (4) Other ethnicity, versus Malay (referent)
- BMI-for-age status: risk in (1) underweight or (2) overweight, versus normal weight (referent)
- Birth order: risk in children of second, third and fourth or higher birth order, versus first born (referent)
- Maternal height: risk in children of mothers with height 155-159cm, 150-154cm, 145-149cm, and <145cm, versus those with height 160cm or higher (referent)
- Maternal current underweight: risk in children of mothers with BMI <18.5 kg/m2, versus those with BMI >=18.5 kg/m2 (referent)
- Rooms (bedrooms, bathrooms, living areas) per household member: risk per unit increase in room to person ratio for each room type
- Type of toilet: risk among children in households with (1) Bore hole toilet, (2) Pour flush toilet, (3) Flush toilet with septic tank, (4) Flush toilet connected with sewerage system, versus those living in households with none, bucket or hanging latrine (referent)
- Toilet shared with other household (yes/no): risk among children in households with a shared toilet, versus those living in households without one
- Main source of drinking water: risk among children in households using water from (1) Public standpipe or other protected source, (2) Piped into yard, (3) Piped into house, versus those living in households using an unprotected source (referent)
- Main method of garbage disposal: risk among children in households having their garbage (1) Collected and thrown for recycling, (2) Collected irregularly by local authority, (3) Collected regularly by local authority, versus in those in households where garbage is buried, burned or thrown (referent)
Methods for crude analysis and gaining an introductory sense of the data include examination of variable distributions and clustering of the outcome variable of interest (stunting or height-for-age). Exposure variables are assessed by stunting status; differences between stunted and non-stunted groups are assessed using Student's t test for continuous variables, and Pearson's chi squared test (Fisher's exact test for variables with cell counts <5) for categorical variables. Additionally, the classification and prevalence of stunting is assessed using two different references: the World Health 2007 reference and Centers for Disease Control and Prevention 2000 reference; agreement in classification between the two is calculated using Cohen's kappa.
The primary method of analysis is mixed effects Poisson regression, with stunting as the outcome of interest. Final models include all exposure variables of interest, in order to assess any independent associations between each exposure and stunting risk. All models are adjusted for clustering at the household level.
A number of secondary analyses are used in order to check the robustness and specificity of associations. These include:
- Adding maternal age as a covariate in models, examining associations of maternal age with stunting, and the effect of its addition on other associations
- Adding in maternal education, paternal education or head of household's education, and assessing subsequent effects as described in (1)
- Adding in paternal height, and assessing subsequent effects as described in (1)
- Adding in a number of theoretically uncorrelated variables to test the specificity of associations, and assessing subsequent effects as described in (1)
- Using mixed effects linear regression, with height-for-age z-score as the outcome of interest. Final models include all exposure variables of interest, in order to assess any independent associations between each exposure and stunting risk. All models are adjusted for clustering at the household level.
Both the primary and secondary analyses are run with stunting or height-for-age expressed according to (1) the Centers for Disease Control and Prevention 2000 reference and (2) the World Health Organization 2007 reference.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study is based on existing observational data collected by the the South East Asia Community Observatory (SEACO), a health and demographic surveillance system (HDSS) covering approximately 45 000 individuals in Segamat, Malaysia. The HDSS regularly (annually) enumerates all consenting households and individuals within its catchment area, and has also conducted a health survey to date during which basic sociodemographic, lifestyle-related and anthropometric data were collected from individuals aged 6 years and above. Further information on the SEACO HDSS can be found at: https://academic.oup.com/ije/article/46/5/1370/4037470.This study uses cross-sectional data on children aged 6-19 years, collected between 2012-2014.
Key inclusion criteria (2 listed)
- Age >= 6 years and <= 19 years
- Whether or not the potential participant has information on all exposure and outcome variables of interest.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention - this is was an observational, cross-sectional study to identify potential risk factors associated with stunting | Other | – |
Primary outcome
Child stunting
Time frame: This was a one-time measurement, taken during a survey.
Stunting was expressed using the Centers for Disease Control and Prevention 2000, and the World Health Organization 2007 references.
1 secondary outcome
Child height-for-age
Time frame: This was a one-time measurement, taken during a survey (as above).
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 8 Dec 2017.
- Background: PubMed 29024948Partap U, Young EH, Allotey P, Soyiri IN, Jahan N, Komahan K, Devarajan N, Sandhu MS, Reidpath DD. HDSS Profile: The South East Asia Community Observatory Health and Demographic Surveillance System (SEACO HDSS). Int J Epidemiol. 2017 Oct 1;46(5):1370-1371g. doi: 10.1093/ije/dyx113. No abstract available.
- South East Asia Community Observatory websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daniel D Reidpath, PhD principal investigator
Monash University Malaysia
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting, run by Manjinder Sandhu.
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 2 inclusion and 0 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Child stunting (time frame: This was a one-time measurement, taken during a survey.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364426, which also lists 1 linked publication.
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 8 Dec 2017.