Uganda Birth Cohort Study (UBC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Anemia; Wasting; Stunting; Birth Outcomes

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:

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

• Study Type: Observational
• Enrollment (Actual): 5044

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women, children under two years, and their households in Northern and Southwestern Uganda during 2014-2016

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: United States Agency for International Development (USAID); Harvard University; Makerere University
• Investigators: Study Director: Patrick Webb, PhD, Tufts, Friedman School of Nutrition; Principal Investigator: Shibani Ghosh, PhD, Tufts, Friedman School of Nutrition

Publications and helpful links

General Publications

• Mezzano J, Namirembe G, Ausman LM, Marino-Costello E, Shrestha R, Erhardt J, Webb P, Ghosh S. Effects of Iron and Vitamin A Levels on Pregnant Women and Birth Outcomes: Complex Relationships Untangled Using a Birth Cohort Study in Uganda. Matern Child Health J. 2022 Jul;26(7):1516-1528. doi: 10.1007/s10995-022-03387-5. Epub 2022 Mar 3.
• Madzorera I, Ghosh S, Wang M, Fawzi W, Isanaka S, Hertzmark E, Namirembe G, Bashaasha B, Agaba E, Turyashemererwa F, Webb P, Duggan C. Prenatal dietary diversity may influence underweight in infants in a Ugandan birth-cohort. Matern Child Nutr. 2021 Jul;17(3):e13127. doi: 10.1111/mcn.13127. Epub 2021 Feb 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2014
• Primary Completion (ACTUAL): November 4, 2016
• Study Completion (ACTUAL): November 4, 2016

Study Registration Dates

• First Submitted: January 11, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Anemia; Growth; Uganda; Stunting; Wasting; Aflatoxin; Birth Outcomes; Environmental Enteric Dysfunction (EED)
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia; Growth Disorders
• Other Study ID Numbers: 11302 (Registry Identifier: DAIDS ES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be publicly available by the end of 2020
• IPD Sharing Time Frame: End of 2020
• IPD Sharing Access Criteria: Data will be publicly accessible

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No