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

HIV Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974972
• Other study ID #: 1405004733
• Status: Completed
• Start date: August 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• HIV
• Maternal and Child Health
• Nutrition

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Kenya Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

Benzaken CL, Miller JD, Onono M, Young SL. Development of a cumulative metric of vaccination adherence behavior and its application among a cohort of 12-month-olds in western Kenya. Vaccine. 2020 Apr 16;38(18):3429-3435. doi: 10.1016/j.vaccine.2020.03.011 — View Citation

Miller JD, Fitzgerald KG, Smith AL, Young SL. Geophagy among a Cohort of Kenyan Women with Mixed HIV Status: A Longitudinal Analysis. Am J Trop Med Hyg. 2019 Sep;101(3):654-660. doi: 10.4269/ajtmh.19-0149. — View Citation

Murnane PM, Miller JD, Tuthill EL, Collins SM, Neilands TB, Onono M, Cohen CR, Weiser SD, Laudenslager ML, Young SL. Perinatal Food Insecurity and Postpartum Psychosocial Stress are Positively Associated Among Kenyan Women of Mixed HIV Status. AIDS Behav. — View Citation

Tuthill EL, Miller JD, Collins SM, Widen EM, Onono M, Young SL. HIV infection, hunger, breastfeeding self-efficacy, and depressive symptoms are associated with exclusive breastfeeding to six months among women in western Kenya: a longitudinal observationa — View Citation

Wang M, Miller JD, Collins SM, Santoso MV, Wekesa P, Okochi H, Onono M, Weiser S, Gandhi M, Young SL. Social Support Mitigates Negative Impact of Food Insecurity on Antiretroviral Adherence Among Postpartum Women in Western Kenya. AIDS Behav. 2020 Mar 24. — View Citation

Widen EM, Tsai I, Collins SM, Wekesa P, China J, Krumdieck N, Miller JD, Weiser SD, Onono M, Young SL. HIV infection and increased food insecurity are associated with adverse body composition changes among pregnant and lactating Kenyan women. Eur J Clin N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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)	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
Secondary	Assessing the Impact of Livestock Ownership on Maternal and Child Health Using Photovoice Qualitative Data Collection Methodology	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