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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974972
First Posted: November 29, 2016
Last Update Posted: August 24, 2017
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.
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Sera Young, Northwestern University
  Purpose
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
Food Insecurity Nutrition Maternal and Child Health HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Sera Young, Northwestern University:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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).


Enrollment: 371
Study Start Date: August 2014
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pith Moromo 2 Cohort

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up 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
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
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
Sponsors and Collaborators
Northwestern University
Kenya Medical Research Institute
  More Information

Responsible Party: Sera Young, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02974972     History of Changes
Other Study ID Numbers: 1405004733
First Submitted: November 21, 2016
First Posted: November 29, 2016
Last Update Posted: August 24, 2017
Last Verified: August 2017

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