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

July 27, 2020 updated by: Sera Young, Northwestern University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pith Moromo 2 Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1405004733

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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