Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
5044 participants
OBSERVATIONAL
2014-11-15
2016-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Maternal EED and Aflatoxin Birth Outcomes Study Uganda
NCT03429257
Improving the Nutrition Status of Infants in South-Western Uganda
NCT02098031
A Livelihood Intervention for Impoverished Women and Children in Rural Uganda
NCT02619279
MNCH Programming in Southwest Uganda Maternal and Child Health In Bushenyi and Rubirizi Districts, UGANDA
NCT01571765
Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda
NCT03112018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
15 Years
49 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Agency for International Development (USAID)
FED
Makerere University
OTHER
Harvard University
OTHER
Tufts University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patrick Webb
Program Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Webb, PhD
Role: STUDY_DIRECTOR
Tufts, Friedman School of Nutrition
Shibani Ghosh, PhD
Role: PRINCIPAL_INVESTIGATOR
Tufts, Friedman School of Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tufts University
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.