StuntingNCT03346473
The Double Burden of Malnutrition Among Adolescents in Low-income and Middle-income Countries
An observational study of Stunting and Thinness, run by University of Warwick.
Trial summary
Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- How many people
- 129,276 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents aged 12-15 years from the Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys.
Who may be able to join
- Low-income or middle-income countries with completed Global School-Based Student Health Survey or Health Behaviour in School-Aged Children surveys.
- Adolescents aged 12-15 years
- Recorded sex, height and weight
Who cannot join
- High-income countries
About this study
Official title: The Double Burden of Malnutrition Among Adolescents: Analysis of Data From the Global School-Based Student Health and Health Behaviour in School-Aged Children Surveys in 57 Low-income and Middle-income Countries
Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.
Read the detailed description
We used the most recent Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight. The GSHS is a World Health Organisation (WHO) initiative, designed to assess health behaviours of adolescents through cross-sectional school-based surveys, across several countries using similar standardised procedures. The HSBC study are WHO sponsored cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to examine the physical and mental health of adolescents in the WHO European Region and North America.
- Medical subject headings
- Growth Disorders, Thinness, Obesity
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 aged 12-15 years in LMICs | No interventions administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of stunting
Trained survey staff measured the height of each student. Stunting was defined as height-for age < 2 standard deviations below the WHO Child Growth Reference median.
Measured: 2003-2013
Prevalence of thinness
Trained survey staff measured the weight of each student. Thinness was defined as BMI-for-age < 2 standard deviations below the WHO Growth Reference median. Body mass index [BMI (weight in kilograms divided by height in meters squared)] was calculated from height and weight.
Measured: 2003-2013
Prevalence of overweight and obesity
Overweight was defined as BMI-for-age > 1 standard deviation above the WHO Growth Reference median) and obesity was defined as >2 standard deviations above the WHO Growth Reference median.
Measured: 2003-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 129,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rishi Caleyachetty, University of Warwick
- Investigators
- Rishi Caleyachetty, MBBS PhD, Principal investigator, Warwick Medical School, Warwick University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346473
- Sponsor's protocol ID
- WAR2017006203
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caleyachetty R, Thomas GN, Kengne AP, Echouffo-Tcheugui JB, Schilsky S, Khodabocus J, Uauy R. The double burden of malnutrition among adolescents: analysis of data from the Global School-Based Student Health and Health Behavior in School-Aged Children surveys in 57 low- and middle-income countries. Am J Clin Nutr. 2018 Aug 1;108(2):414-424. doi: 10.1093/ajcn/nqy105.
PubMed 29947727
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Double Burden of Malnutrition Among Adolescents: Analysis of Data From the Global School-Based Student Health and Health Behaviour in School-Aged Children Surveys in 57 Low-income and Middle-income Countries
- ClinicalTrials.gov ID
- NCT03346473
- Acronym / sponsor ID
- WAR2017006203
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129,276 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Nov 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.
Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.
Detailed description
We used the most recent Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight. The GSHS is a World Health Organisation (WHO) initiative, designed to assess health behaviours of adolescents through cross-sectional school-based surveys, across several countries using similar standardised procedures. The HSBC study are WHO sponsored cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to examine the physical and mental health of adolescents in the WHO European Region and North America.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents aged 12-15 years in LMICs | – | –No interventions administered |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents aged 12-15 years from the Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys.
Key inclusion criteria (3 listed)
- Low-income or middle-income countries with completed Global School-Based Student Health Survey or Health Behaviour in School-Aged Children surveys.
- Adolescents aged 12-15 years
- Recorded sex, height and weight
Key exclusion criteria (1 listed)
- High-income countries
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
Prevalence of stunting
Time frame: 2003-2013
Trained survey staff measured the height of each student. Stunting was defined as height-for age < 2 standard deviations below the WHO Child Growth Reference median.
Prevalence of thinness
Time frame: 2003-2013
Trained survey staff measured the weight of each student. Thinness was defined as BMI-for-age < 2 standard deviations below the WHO Growth Reference median. Body mass index [BMI (weight in kilograms divided by height in meters squared)] was calculated from height and weight.
Prevalence of overweight and obesity
Time frame: 2003-2013
Overweight was defined as BMI-for-age > 1 standard deviation above the WHO Growth Reference median) and obesity was defined as >2 standard deviations above the WHO Growth Reference median.
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 17 Nov 2017.
- Derived from this study: PubMed 29947727Caleyachetty R, Thomas GN, Kengne AP, Echouffo-Tcheugui JB, Schilsky S, Khodabocus J, Uauy R. The double burden of malnutrition among adolescents: analysis of data from the Global School-Based Student Health and Health Behavior in School-Aged Children surveys in 57 low- and middle-income countries. Am J Clin Nutr. 2018 Aug 1;108(2):414-424. doi: 10.1093/ajcn/nqy105.
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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.
Rishi Caleyachetty, MBBS PhD principal investigator
Warwick Medical School, Warwick University
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting and Thinness, run by University of Warwick.
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 3 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 17 Nov 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?
Prevalence of stunting (time frame: 2003-2013). The study lists 3 primary outcomes in all. 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 NCT03346473, 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 17 Nov 2017.