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Early Childhood Nutrition and Adult Outcomes in India

5 de julho de 2017 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

1360

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 25 anos (Adulto)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The likelihood of a study participant completing at least secondary school, i.e. class X/XII, intermediate, vocational course, or equivalent
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: Up to 25 years
Binary indicator of employment or higher education enrollment
Up to 25 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 1987

Conclusão Primária (Real)

31 de dezembro de 1990

Conclusão do estudo (Real)

31 de dezembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de junho de 2017

Primeira postagem (Real)

2 de julho de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de julho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de julho de 2017

Última verificação

1 de julho de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • APCAPS2017

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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