- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364426
Characterisation and Sociodemographic Determinants of Stunting Among Malaysian Children Aged 6-19 Years
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >= 6 years and <= 19 years
- Whether or not the potential participant has information on all exposure and outcome variables of interest.
Exclusion Criteria None
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
This was a one-time measurement, taken during a survey.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child height-for-age
Time Frame: This was a one-time measurement, taken during a survey (as above).
|
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).
|
This was a one-time measurement, taken during a survey (as above).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel D Reidpath, PhD, Monash University Malaysia
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1203-0963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stunting
-
Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter, MalawiCompletedNutritional StuntingMalawi
-
International Centre for Diarrhoeal Disease Research...University of WashingtonCompletedNutritional StuntingBangladesh
-
Indonesia UniversityWyeth nutrition indonesiaCompletedGrowth; Stunting, NutritionalIndonesia
-
Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
-
University of South CarolinaHelen Keller InternationalCompleted
-
International Centre for Diarrhoeal Disease Research...Department for International Development, United Kingdom; University of Sydney and other collaboratorsCompleted
-
Swiss Federal Institute of TechnologyBRAC University; HarvestPlusCompletedZinc Deficiency | Growth; Stunting, NutritionalSwitzerland, Bangladesh
-
University of CopenhagenUniversity of Aarhus; Arla FoodsCompletedGrowth Acceleration | Growth; Stunting, NutritionalDenmark
-
Andalas UniversityIndonesia UniversityCompletedGastrointestinal Microbiome | Growth; Stunting, Nutritional | Immunoglobulin AIndonesia
-
Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
Clinical Trials on No intervention
-
Hopital FochNot yet recruitingInterstitial Lung DiseaseFrance
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... and other collaboratorsRecruitingHead and Neck Squamous Cell Carcinoma | Patient Derived Organoid | Drug Sensitive Test in VitroChina
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of Dublin, Trinity CollegeCompleted