UBC: Uganda Birth Cohort Study

Sponsor

Tufts University (Other)

Overall Status

Terminated

CT.gov ID

NCT04233944

Collaborator

United States Agency for International Development (USAID) (U.S. Fed), Makerere University (Other), Harvard University (Other)

5,044

Enrollment

Location

23.7

Actual Duration (Months)

213.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Outcomes Stunting Wasting Anemia

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

5044 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 15, 2014

Actual Primary Completion Date :

Nov 4, 2016

Actual Study Completion Date :

Nov 4, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women and their infants 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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