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

Completed

• Conditions: Food Insecurity; Nutrition; Maternal and Child Health; HIV

• Registration Number: NCT02974972
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-29
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 371

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

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Exclusion Criteria

• Individuals <18 years of age that are not infants born to women enrolled in the cohort study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
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)	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	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).

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Evanston, Illinois, United States