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

NCT02974972 | Completed

• 1 other identifier: 1405004733
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity; Nutrition; Maternal and Child Health; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Assessing the Impact of Livestock Ownership on Maternal and Child Health Using Photovoice Qualitative Data Collection Methodology

  1 year

Study Arms (1)

Pith Moromo 2 Cohort

Eligibility Criteria

• Age: 1 Day - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Related Publications (7)

• 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. 2020 Jun;24(6):1632-1642. doi: 10.1007/s10461-019-02676-5.

  PMID: 31538283 RESULT

• 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 Oct;24(10):2885-2894. doi: 10.1007/s10461-020-02839-9.

  PMID: 32212069 RESULT

• 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 Nutr. 2019 Mar;73(3):474-482. doi: 10.1038/s41430-018-0285-9. Epub 2018 Sep 5.

  PMID: 30185898 RESULT

• 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.

  PMID: 31333167 RESULT

• 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 observational study. Int Breastfeed J. 2020 Jan 16;15(1):4. doi: 10.1186/s13006-019-0251-8.

  PMID: 31948438 RESULT

• 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. Epub 2020 Mar 14.

  PMID: 32184035 RESULT

• Alvarez GG, Miller JD, Santoso MV, Wekesa P, Owuor PM, Onono M, Young SL. Prevalence and Covariates of Food Insecurity Across the First 1000 Days Among Women of Mixed HIV Status in Western Kenya: A Longitudinal Perspective. Food Nutr Bull. 2021 Sep;42(3):319-333. doi: 10.1177/0379572121999024. Epub 2021 May 20.

  PMID: 34011176 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (1)