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Uganda Birth Cohort Study (UBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233944
Recruitment Status : Terminated (Funding constraints)
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Makerere University
Harvard University
Information provided by (Responsible Party):
Patrick Webb, Tufts University

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
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:

  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

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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 : November 15, 2014
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : November 4, 2016

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.



Primary Outcome Measures :
  1. Percent of infants who were stunted [ Time Frame: 0-2 years old ]
    Percent of infants with a height-for-age less than -2 standard deviations

  2. Percent of infants who were wasted [ Time Frame: 0-2 years old ]
    Percent of infants with a weight-for-height less than -2 standard deviations

  3. Percent of infants who were underweight [ Time Frame: 0-2 years old ]
    Percent of infants with a weight-for-age less than -2 standard deviations

  4. Infants' weight at birth (kg) [ Time Frame: Birth ]
    Birth weight in kilograms using a seca scale, calculated as the mean of three repeated measurements on each infant

  5. Percentage of infants with low birth weight [ Time Frame: Birth ]
    Percentage of infants with birth weight less than 2500 grams

  6. Percentage of preterm births [ Time Frame: Birth ]
    Percentage of infants born with a gestational age less than 259 days

  7. Percentage of infants who were small-for-gestational-age [ Time Frame: Birth ]
    Percentage of infants at birth whose weight centiles were below the 10th percentile for their age and sex

  8. Head circumference measurement (cm) [ Time Frame: 0-2 years old ]
    Infant's head circumference measured in centimeters


Secondary Outcome Measures :
  1. Percent of mothers that were anemic (hemoglobin levels <11 g/dL) [ Time Frame: through study completion, every 3 months ]
    Percentage of maternal anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test.

  2. Percent of infants that were anemic (hemoglobin levels <11 g/dL) [ Time Frame: 0-2 years old ]
    Percentage of infants with anemia defined by hemoglobin levels <11 g/dL, measured using the HemoCue test.

  3. Concentration of ferritin (ug/L) in mothers and infants as a biomarker for iron status [ Time Frame: 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

  4. Concentration of soluble transferrin receptor (mg/L) in mothers and infants as a biomarker for iron status [ Time Frame: 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

  5. Concentration of retinol binding protein (umol/L) in mothers and infants as a biomarker for vitamin A status [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes 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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233944


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
United States Agency for International Development (USAID)
Makerere University
Harvard University
Investigators
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Study Director: Patrick Webb, PhD Tufts, Friedman School of Nutrition
Principal Investigator: Shibani Ghosh, PhD Tufts, Friedman School of Nutrition
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick Webb, Program Director, Tufts University
ClinicalTrials.gov Identifier: NCT04233944    
Other Study ID Numbers: 11302
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be publicly available by the end of 2020
Time Frame: End of 2020
Access Criteria: Data will be publicly accessible

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick Webb, Tufts University:
Birth Outcomes
Pregnancy
Aflatoxin
Environmental Enteric Dysfunction (EED)
Growth
Stunting
Wasting
Uganda
Anemia
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Growth Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Pathologic Processes