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Pith Moromo 2: Cohort to Study Health Consequences of Food and Nutrition Insecurity During Pregnancy and Lactation (PM2)

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: NCT02974972
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Sera Young, Northwestern University

Study Description
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Brief Summary:
In this study, the investigators conducted research among HIV-infected and -uninfected pregnant and lactating women to understand the potential role and importance of food insecurity on participant physical and psychosocial health and nutrition.

Condition or disease
Food Insecurity Nutrition Maternal and Child Health HIV

Detailed Description:

The central hypothesis of this study was that food and nutrition insecurity are detrimental to the health of HIV+ pregnant women and their infants via nutritional, disease, and psychosocial pathways.

In the first phase, the investigators collected descriptive data to describe and assess food and nutrition insecurity and the associated modifiable determinants among HIV+ pregnant and lactating women in Kenya.

In the second phase, the investigators collected longitudinal cohort data from women who were recruited during pregnancy and have been followed throughout the infant's first year of life.

Study Design
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Study Type : Observational
Actual Enrollment : 371 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort
Pith Moromo 2 Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Describing and Assessing the Modifiable Determinants of Food Insecurity (using the Individual Food Insecurity Access Scale) Using A Demography, Health, Nutrition, and Psychosocial Questionnaire at 7 Time Points from Pregnancy to 9 Months Postpartum. [ Time Frame: 2 years ]
    In the first phase the investigators completed descriptive data analysis to describe and assess food and nutrition insecurity and the associated modifiable determinants among HIV+ pregnant and lactating women in Kenya.


Secondary Outcome Measures :
  1. Impacts of Food Insecurity (using the Individual Food Insecurity Access Scale) on Maternal and Infant Biomarkers of Health (including anthropometry, hemoglobin, and bioelectrical impedance analysis) [ Time Frame: 2 years ]
    The investigators collected longitudinal cohort data from women who were recruited during pregnancy and have been followed throughout the infant's first year of life. Participants were interviewed at regular intervals and anthropometry and other biomarkers were periodically assessed.

  2. Assessing the Impact of Livestock Ownership on Maternal and Child Health Using Photovoice Qualitative Data Collection Methodology [ Time Frame: 1 year ]
    The investigators collected qualitative data using Photovoice, a participatory photo-elicitation data collection methodology to explore the livestock ownership and perceptions of livestock on household food security (using the Household Food Insecurity Access Scale).


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A cohort of 371 pregnant HIV-infected and -uninfected women (ratio 1:1) were recruited from 7 rural and urban clinics in Nyanza, Kenya. Participants were followed from ≤30 weeks pregnancy until 9 months postpartum.
Criteria

Inclusion Criteria:

  • Women >18 years of age with infants
  • Infants born to pregnant women enrolled in the cohort study
  • HIV-infected pregnant women >18 years of age and ≤30 weeks gestation
  • HIV-uninfected pregnant women >18 years of age and ≤30 weeks gestation

Exclusion Criteria:

  • Individuals <18 years of age that are not infants born to women enrolled in the cohort study
Contacts and Locations
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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): NCT02974972


Locations
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United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
Sponsors and Collaborators
Northwestern University
Kenya Medical Research Institute
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sera Young, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02974972    
Other Study ID Numbers: 1405004733
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No