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Early Childhood Nutrition and Adult Outcomes in India

5 luglio 2017 aggiornato da: University of Chicago

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1360

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 25 anni (Adulto)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • All participants in the publicly available data from the APCAPS 2010-2012 survey round.

Exclusion Criteria:

  • None

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
A balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma'.
Control
No supplement was provided in 14 control villages.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The likelihood of a study participant completing at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent
Lasso di tempo: Up to 25 years
Binary indicator of secondary level education
Up to 25 years
The likelihood of a study participant completing at least graduate level education, i.e. Bachelor's degree, diploma, or equivalent
Lasso di tempo: Up to 25 years
Binary indicator of graduate level education
Up to 25 years
The likelihood of a study participant being ever-married (currently married, widowed, or divorced)
Lasso di tempo: Up to 25 years
Binary indicator of marriage
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)
Lasso di tempo: Up to 25 years
Binary indicator of employment or higher education enrollment
Up to 25 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Arindam Nandi, PhD, University of Chicago
  • Investigatore principale: Jere R Behrman, PhD, University of Pennsylvania
  • Investigatore principale: Sanjay Kinra, PhD, London School of Hygiene and Tropical Medicine
  • Investigatore principale: Ramanan Laxminarayan, PhD, Center for Disease Dynamics, Economics & Policy

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 1987

Completamento primario (Effettivo)

31 dicembre 1990

Completamento dello studio (Effettivo)

31 dicembre 2012

Date di iscrizione allo studio

Primo inviato

29 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2017

Primo Inserito (Effettivo)

2 luglio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • APCAPS2017

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Dati/documenti di studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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