Clinical trial NCT04233944: Uganda Birth Cohort Study
Official title: Effectiveness of Integrated Livelihood and Nutrition Interventions to Improve Maternal and Child Nutrition and Health in Rural Uganda: A Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Birth Outcomes
Stunting
Wasting
Anemia
Keywords: Birth Outcomes
Pregnancy
Aflatoxin
Environmental Enteric Dysfunction (EED)
Growth
Stunting
Wasting
Uganda
Anemia
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Makerere University
name: Harvard University
First posted: 2020-01-18
Enrollment: 5044
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women, children under two years, and their households in Northern and Southwestern Uganda during 2014-2016

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Percent of infants who were stunted
timeFrame: 0-2 years old
measure: Percent of infants who were wasted
timeFrame: 0-2 years old
measure: Percent of infants who were underweight
timeFrame: 0-2 years old
measure: Infants' weight at birth (kg)
timeFrame: Birth
measure: Percentage of infants with low birth weight
timeFrame: Birth
measure: Percentage of preterm births
timeFrame: Birth
measure: Percentage of infants who were small-for-gestational-age
timeFrame: Birth
measure: Head circumference measurement (cm)
timeFrame: 0-2 years old
Secondary outcomes:
measure: Percent of mothers that were anemic (hemoglobin levels <11 g/dL)
timeFrame: through study completion, every 3 months
measure: Percent of infants that were anemic (hemoglobin levels <11 g/dL)
timeFrame: 0-2 years old
measure: Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status
timeFrame: 6 months for infants, mothers at birth
measure: Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status
timeFrame: 6 months for infants, mothers at birth
measure: Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status
timeFrame: 6 months for infants, mothers at birth
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts, Friedman School of Nutrition
name: Patrick Webb, PhD
role: STUDY_DIRECTOR
affiliation: Tufts, Friedman School of Nutrition
name: Shibani Ghosh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.