Uganda Birth Cohort Study

Anemia Clinical Trial

— UBC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04233944
• Other study ID #: 11302
• Status: Terminated
• Start date: November 15, 2014
• Est. completion date: November 4, 2016

Study information

• Verified date: January 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

1. 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

2. To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length

3. To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth

4. To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities

5. 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5044
• Est. completion date: November 4, 2016
• Est. primary completion date: November 4, 2016
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Birth Outcomes
• Cachexia
• Growth Disorders
• Stunting
• Wasting

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Tufts University	Harvard University, Makerere University, United States Agency for International Development (USAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of infants who were stunted	Percent of infants with a height-for-age less than -2 standard deviations	0-2 years old
Primary	Percent of infants who were wasted	Percent of infants with a weight-for-height less than -2 standard deviations	0-2 years old
Primary	Percent of infants who were underweight	Percent of infants with a weight-for-age less than -2 standard deviations	0-2 years old
Primary	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
Primary	Percentage of infants with low birth weight	Percentage of infants with birth weight less than 2500 grams	Birth
Primary	Percentage of preterm births	Percentage of infants born with a gestational age less than 259 days	Birth
Primary	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
Primary	Head circumference measurement (cm)	Infant's head circumference measured in centimeters	0-2 years old
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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