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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02974972
Acronym
PM2
Enrollment
371
Registered
2016-11-29
Start date
2014-08-31
Completion date
2017-05-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity, HIV, Maternal and Child Health, Nutrition

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.

Interventions

None listed

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
1 Days to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 yearsIn 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

MeasureTime frameDescription
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 yearsThe 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 Methodology1 yearThe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026