Uganda Birth Cohort Study

Study Overview
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Brief Summary
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The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016. The aim of the UBC study was to observationally follow pregnant women and their newborns until 2 years of age and compare changes over time in communities that were part of an ongoing USAID project called the Community Connector (CC) compared to those communities that were not included in the Community Connector project.

Detailed Description
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This study aimed to assess the role of livelihoods, agriculture and nutrition in improving maternal and child nutrition and health in rural Uganda in communities that were a part of an ongoing program that was un-related to the study. The overall aim of this study was to understand the effect of participating in an ongoing program that provided support on nutrition, agriculture, water, hygiene and sanitation and the change over time in the nutritional status of mothers and children under two years of age. The specific objectives of this observational study were as follows: To compare health and nutrition status of pregnant women in communities participating in the Community Connector project to those that were not participating in the program To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities To determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Official Title
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Effectiveness of Integrated Livelihood and Nutrition Interventions to Improve Maternal and Child Nutrition and Health in Rural Uganda: A Birth Cohort Study

Conditions
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Birth Outcomes, Stunting, Wasting, Anemia

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Inclusion into pregnancy surveillance: Participant is a woman aged 15-49 years Participant intends to reside in the study area through the enrollment period Participant provides informed consent herself or through a legal guardian Inclusion into main study: Pregnancy is confirmed by urine pregnancy test Mother is aged 15-49 years Mother intends to reside in the study area through completion of follow-up Mother intends to deliver in the study area Mother provides informed consent (potentially as an emancipated minor) Exclusion criteria: -None

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women and their infants<br>Mothers and their infants were followed throughout the first two years of the infant's life. Data were collected at enrollment, birth, 3, 6, 9,12, 18 and 24 months from the date of delivery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of infants who were stunted | Percent of infants with a height-for-age less than -2 standard deviations | 0-2 years old | 
| Percent of infants who were wasted | Percent of infants with a weight-for-height less than -2 standard deviations | 0-2 years old | 
| Percent of infants who were underweight | Percent of infants with a weight-for-age less than -2 standard deviations | 0-2 years old | 
| Infants' weight at birth (kg) | Birth weight in kilograms using a seca scale, calculated as the mean of three repeated measurements on each infant | Birth | 
| Percentage of infants with low birth weight | Percentage of infants with birth weight less than 2500 grams | Birth | 
| Percentage of preterm births | Percentage of infants born with a gestational age less than 259 days | Birth | 
| Percentage of infants who were small-for-gestational-age | Percentage of infants at birth whose weight centiles were below the 10th percentile for their age and sex | Birth | 
| Head circumference measurement (cm) | Infant's head circumference measured in centimeters | 0-2 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of mothers that were anemic (hemoglobin levels <11 g/dL) | Percentage of maternal anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test. | through study completion, every 3 months | 
| Percent of infants that were anemic (hemoglobin levels <11 g/dL) | Percentage of infants with anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test. | 0-2 years old | 
| Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status | Maternal and infants' serum ferritin (ug/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany | 6 months for infants, mothers at birth | 
| Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status | Maternal and infants' serum soluble transferrin receptor (mg/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany | 6 months for infants, mothers at birth | 
| Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status | Maternal and infants' serum retinol binding protein (umol/L) measured using a sandwich enzyme-linked immunosorbent assay technique (ELISA) at the VitMin Lab in Germany | 6 months for infants, mothers at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth Outcomes, Pregnancy, Aflatoxin, Environmental Enteric Dysfunction (EED), Growth, Stunting, Wasting, Uganda, Anemia