Nonhealth OutcomesNCT03207321
Early Childhood Nutrition and Adult Outcomes in India
An observational study of Nonhealth Outcomes, run by University of Chicago.
Trial summary
This study will investigate the association between exposure to a daily nutritional supplement in utero and during the first three years of life and adult educational, marriage, and labor market outcomes in India. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Nonhealth Outcomes
- What is being tested?
- Upma
- How many people
- 1,360 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1987to 31 Dec 2012
- 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 20 to 25 years
- All sexes
- Adult
Study population: The 1987-1990 Hyderabad Nutrition Trial enrolled pregnant women and young children from 29 villages in administrative areas near the city of Hyderabad in the state of Andhra Pradesh (now in Telangana). First, two adjacent sub-districts (group of villages, called a block) were selected for the study - one for the intervention group and the other as control. Then, 15 intervention and 14 control villages were selected. Intervention and control group villages had similar levels of access to other public health programs such as immunization and anemia control in pregnancy. The children originally born in the study villages during 1987-1990 have been tracked and surveyed several times during 2003-2012. This study will use the the 2010-2012 survey data which include 1,360 (715 intervention and 645 control) adults of age 20-25 years who were originally born during the trial.
Who may be able to join
- All participants in the publicly available data from the APCAPS 2010-2012 survey round.
Who cannot join
- None
About this study
Official title: Analysis of the Association Between Early Childhood Nutrition and Adult Outcomes Using Andhra Pradesh Children and Parents Study (APCAPS) Data
This study will investigate the association between exposure to a daily nutritional supplement in utero and during the first three years of life and adult educational, marriage, and labor market outcomes in India. During 1987-1990, a controlled nutrition trial offered a daily cooked meal to pregnant women and children below the age of six years in 15 intervention villages near the city of Hyderabad in South India. No supplementation was offered during the study in another 14 control villages. The trial and its follow up surveys are together known as the Andhra Pradesh Children and Parents Study (APCAPS).
This protocol registration is for an analysis of the publicly available APCAPS third follow up wave (2010-2012) data. It is not a registration of the underlying 1987-1990 nutrition trial.
Read the detailed description
The investigators plan to use the 2010-2012 wave of the APCAPS data. They will access these publicly available data by applying for collaboration with the APCAPS study group.
The 2010-2012 follow-up survey invited all surviving children born during the original trial period of 1987-1990 (hereafter called index children) to participate. These index children were 20-25 years old at the time of this survey. Of the invited index children, 1,360 (715 in intervention villages and 645 in control villages) participated. The APCAPS surveys have collected a wide variety of data on socio-demographics, lifestyle, medical history, mental and reproductive health, anthropometry, cardiovascular physiology, spirometry, and biomarkers.
Using these data, the investigators will examine the association between birth in an intervention village and adult educational, marriage and labor market outcomes. For each study participant, a survey question collected information on the highest level of education attained by the participant (self-reported). From this variable, the investigators will create two indicators of whether the adult: (1) completed at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent; (2) completed at least graduate level, i.e. Bachelor's degree, diploma, or equivalent.
The third outcome variable of the analysis will be whether the adult was ever-married (currently married, widowed, or divorced) at the time of the survey. Finally, the investigators will also examine whether the adult was either employed in paid or unpaid (e.g. household agriculture) work, or enrolled in higher education (degree or training course).
The investigators will use at least two different analytical methods. First, they will conduct a multivariate regression analysis (logit or probit) of each of the four outcome indicators. Along with the main independent variable of interest - birth in an intervention village - the model will include the following covariates: age, sex (whether female), and birth order of the index child, indicators of parental schooling attainment, religion, caste, and household standard of living as measured by quintiles of a composite asset index. All standard errors of regression will be heteoskedasticity-robust and clustered at the village level. The analysis will be conducted (and results reported) for the full sample and separately for the male and female subsamples.
In order to mitigate any bias arising from systematic differences in the characteristics of the intervention and control village adults (e.g. due to non-random attrition or other reasons), the investigators will also use quasi-experimental matching methods. One widely used methodology is matching based on propensity scores. The investigators will first conduct a selection analysis in which the likelihood of birth in an intervention village is regressed (probit or logit model) on the set of participant, parental, and household covariates mentioned above. Then, based on the predicted probability of intervention assignment (called propensity score) obtained from this model, participants in the intervention group will be matched with similar participant(s) in the control group. The investigators will use a variety of matching algorithms in order to test the sensitivity of the results, e.g. one-to-one nearest neighbor, Kernel, and multiple nearest neighbors matching. Common metrics for the quality of matching exercise and covariate balancing tests will be reported.
After matching, the investigators will report the average difference in outcome indicators between the intervention and matched control groups (technically named as the average treatment effect on the treated) as the estimated association between birth in an intervention village and adult outcomes. Findings from the full sample as well as male and female subsamples will be reported.
- Conditions
- Nonhealth Outcomes
- Being tested
- Upma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpmaDietary supplement
A balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma'.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | In 15 intervention villages, a balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma' - was offered daily to pregnant women and children under six years of age during 1987-1990. The meal provided on average 500 kcal energy and 20-25g of protein to women and half of those amounts to children. Receives: Dietary Supplement: Upma | |
| Control | No supplement was provided in 14 control villages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The likelihood of a study participant completing at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent
Binary indicator of secondary level education
Measured: Up to 25 years
The likelihood of a study participant completing at least graduate level education, i.e. Bachelor's degree, diploma, or equivalent
Binary indicator of graduate level education
Measured: Up to 25 years
The likelihood of a study participant being ever-married (currently married, widowed, or divorced)
Binary indicator of marriage
Measured: Up to 25 years
The likelihood of a study participant being employed in paid or unpaid work, or enrolled in further education (degree or training courses)
Binary indicator of employment or higher education enrollment
Measured: Up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jan 1987
- Primary completion31 Dec 1990
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nonhealth OutcomesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arindam Nandi, PhD, Principal investigator, University of ChicagoJere R Behrman, PhD, Principal investigator, University of PennsylvaniaSanjay Kinra, PhD, Principal investigator, London School of Hygiene and Tropical MedicineRamanan Laxminarayan, PhD, Principal investigator, Center for Disease Dynamics, Economics & Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207321
- Sponsor's protocol ID
- APCAPS2017
- Status last verified
- Jul 2017
- First submitted
- 29 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kinra S, Rameshwar Sarma KV, Ghafoorunissa, Mendu VV, Ravikumar R, Mohan V, Wilkinson IB, Cockcroft JR, Davey Smith G, Ben-Shlomo Y. Effect of integration of supplemental nutrition with public health programmes in pregnancy and early childhood on cardiovascular risk in rural Indian adolescents: long term follow-up of Hyderabad nutrition trial. BMJ. 2008 Jul 25;337:a605. doi: 10.1136/bmj.a605.
PubMed 18658189Kinra S, Sarma KV, Hards M, Smith GD, Ben-Shlomo Y. Is relative leg length a biomarker of childhood nutrition? Long-term follow-up of the Hyderabad Nutrition Trial. Int J Epidemiol. 2011 Aug;40(4):1022-9. doi: 10.1093/ije/dyr074. Epub 2011 May 10.
PubMed 21561932Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. Journal of the American Statistical Association. 1984;79:516-24
Heckman JJ, Ichimura H, Todd PE. Matching as an Econometric Evaluation Estimator: Evidence from Evaluating a Job Training Programme. Review of Economic Studies. 1997;64:605-54
Dehejia RH, Wahba S. Propensity Score-Matching Methods For Nonexperimental Causal Studies. The Review of Economics and Statistics. 2002;84:151-61
Nandi A, Ashok A, Kinra S, Behrman JR, Laxminarayan R. Early Childhood Nutrition Is Positively Associated with Adolescent Educational Outcomes: Evidence from the Andhra Pradesh Child and Parents Study (APCAPS). J Nutr. 2015 Apr 1;146(4):806-813. doi: 10.3945/jn.115.223198.
PubMed 26962175
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Association Between Early Childhood Nutrition and Adult Outcomes Using Andhra Pradesh Children and Parents Study (APCAPS) Data
- ClinicalTrials.gov ID
- NCT03207321
- Acronym / sponsor ID
- APCAPS2017
- Conditions
- Nonhealth Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jan 1987 (actual)
- Primary completion
- 31 Dec 1990 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 2 Jul 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.
This study will investigate the association between exposure to a daily nutritional supplement in utero and during the first three years of life and adult educational, marriage, and labor market outcomes in India. During 1987-1990, a controlled nutrition trial offered a daily cooked meal to pregnant women and children below the age of six years in 15 intervention villages near the city of Hyderabad in South India. No supplementation was offered during the study in another 14 control villages. The trial and its follow up surveys are together known as the Andhra Pradesh Children and Parents Study (APCAPS).
This protocol registration is for an analysis of the publicly available APCAPS third follow up wave (2010-2012) data. It is not a registration of the underlying 1987-1990 nutrition trial.
Detailed description
The investigators plan to use the 2010-2012 wave of the APCAPS data. They will access these publicly available data by applying for collaboration with the APCAPS study group.
The 2010-2012 follow-up survey invited all surviving children born during the original trial period of 1987-1990 (hereafter called index children) to participate. These index children were 20-25 years old at the time of this survey. Of the invited index children, 1,360 (715 in intervention villages and 645 in control villages) participated. The APCAPS surveys have collected a wide variety of data on socio-demographics, lifestyle, medical history, mental and reproductive health, anthropometry, cardiovascular physiology, spirometry, and biomarkers.
Using these data, the investigators will examine the association between birth in an intervention village and adult educational, marriage and labor market outcomes. For each study participant, a survey question collected information on the highest level of education attained by the participant (self-reported). From this variable, the investigators will create two indicators of whether the adult: (1) completed at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent; (2) completed at least graduate level, i.e. Bachelor's degree, diploma, or equivalent.
The third outcome variable of the analysis will be whether the adult was ever-married (currently married, widowed, or divorced) at the time of the survey. Finally, the investigators will also examine whether the adult was either employed in paid or unpaid (e.g. household agriculture) work, or enrolled in higher education (degree or training course).
The investigators will use at least two different analytical methods. First, they will conduct a multivariate regression analysis (logit or probit) of each of the four outcome indicators. Along with the main independent variable of interest - birth in an intervention village - the model will include the following covariates: age, sex (whether female), and birth order of the index child, indicators of parental schooling attainment, religion, caste, and household standard of living as measured by quintiles of a composite asset index. All standard errors of regression will be heteoskedasticity-robust and clustered at the village level. The analysis will be conducted (and results reported) for the full sample and separately for the male and female subsamples.
In order to mitigate any bias arising from systematic differences in the characteristics of the intervention and control village adults (e.g. due to non-random attrition or other reasons), the investigators will also use quasi-experimental matching methods. One widely used methodology is matching based on propensity scores. The investigators will first conduct a selection analysis in which the likelihood of birth in an intervention village is regressed (probit or logit model) on the set of participant, parental, and household covariates mentioned above. Then, based on the predicted probability of intervention assignment (called propensity score) obtained from this model, participants in the intervention group will be matched with similar participant(s) in the control group. The investigators will use a variety of matching algorithms in order to test the sensitivity of the results, e.g. one-to-one nearest neighbor, Kernel, and multiple nearest neighbors matching. Common metrics for the quality of matching exercise and covariate balancing tests will be reported.
After matching, the investigators will report the average difference in outcome indicators between the intervention and matched control groups (technically named as the average treatment effect on the treated) as the estimated association between birth in an intervention village and adult outcomes. Findings from the full sample as well as male and female subsamples will be reported.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Dietary Supplement: UpmaIn 15 intervention villages, a balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma' - was offered daily to pregnant women and children under six years of age during 1987-1990. The meal provided on average 500 kcal energy and 20-25g of protein to women and half of those amounts to children. |
| Control | – | –No supplement was provided in 14 control villages. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Age groups
- Adult
- Study population
- The 1987-1990 Hyderabad Nutrition Trial enrolled pregnant women and young children from 29 villages in administrative areas near the city of Hyderabad in the state of Andhra Pradesh (now in Telangana). First, two adjacent sub-districts (group of villages, called a block) were selected for the study - one for the intervention group and the other as control. Then, 15 intervention and 14 control villages were selected. Intervention and control group villages had similar levels of access to other public health programs such as immunization and anemia control in pregnancy. The children originally born in the study villages during 1987-1990 have been tracked and surveyed several times during 2003-2012. This study will use the the 2010-2012 survey data which include 1,360 (715 intervention and 645 control) adults of age 20-25 years who were originally born during the trial.
Key inclusion criteria (1 listed)
- All participants in the publicly available data from the APCAPS 2010-2012 survey round.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpmaA balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma'. | Dietary supplement | Intervention |
Primary outcome
The likelihood of a study participant completing at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent
Time frame: Up to 25 years
Binary indicator of secondary level education
The likelihood of a study participant completing at least graduate level education, i.e. Bachelor's degree, diploma, or equivalent
Time frame: Up to 25 years
Binary indicator of graduate level education
The likelihood of a study participant being ever-married (currently married, widowed, or divorced)
Time frame: Up to 25 years
Binary indicator of marriage
The likelihood of a study participant being employed in paid or unpaid work, or enrolled in further education (degree or training courses)
Time frame: Up to 25 years
Binary indicator of employment or higher education enrollment
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 11 Jul 2017.
- Background: PubMed 18658189Kinra S, Rameshwar Sarma KV, Ghafoorunissa, Mendu VV, Ravikumar R, Mohan V, Wilkinson IB, Cockcroft JR, Davey Smith G, Ben-Shlomo Y. Effect of integration of supplemental nutrition with public health programmes in pregnancy and early childhood on cardiovascular risk in rural Indian adolescents: long term follow-up of Hyderabad nutrition trial. BMJ. 2008 Jul 25;337:a605. doi: 10.1136/bmj.a605.
- Background: PubMed 21561932Kinra S, Sarma KV, Hards M, Smith GD, Ben-Shlomo Y. Is relative leg length a biomarker of childhood nutrition? Long-term follow-up of the Hyderabad Nutrition Trial. Int J Epidemiol. 2011 Aug;40(4):1022-9. doi: 10.1093/ije/dyr074. Epub 2011 May 10.
- BackgroundRosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. Journal of the American Statistical Association. 1984;79:516-24
- BackgroundHeckman JJ, Ichimura H, Todd PE. Matching as an Econometric Evaluation Estimator: Evidence from Evaluating a Job Training Programme. Review of Economic Studies. 1997;64:605-54
- BackgroundDehejia RH, Wahba S. Propensity Score-Matching Methods For Nonexperimental Causal Studies. The Review of Economics and Statistics. 2002;84:151-61
- Background: PubMed 26962175Nandi A, Ashok A, Kinra S, Behrman JR, Laxminarayan R. Early Childhood Nutrition Is Positively Associated with Adolescent Educational Outcomes: Evidence from the Andhra Pradesh Child and Parents Study (APCAPS). J Nutr. 2015 Apr 1;146(4):806-813. doi: 10.3945/jn.115.223198.
- Individual participant dataSharing planned: No
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.
Arindam Nandi, PhD principal investigator
University of Chicago
Jere R Behrman, PhD principal investigator
University of Pennsylvania
Sanjay Kinra, PhD principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Nonhealth Outcomes, run by University of Chicago.
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 11 Jul 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?
The likelihood of a study participant completing at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent (time frame: Up to 25 years). The study lists 4 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 NCT03207321, which also lists 6 linked publications.
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 11 Jul 2017.