Pith Moromo 2: Cohort to Study Health Consequences of Food and Nutrition Insecurity During Pregnancy and Lactation (PM2)
27. juli 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
371
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
-
Evanston, Illinois, Forenede Stater, 60208
- Northwestern University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 dag til 45 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Pith Moromo 2 Cohort
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2014
Primær færdiggørelse (Faktiske)
1. maj 2017
Studieafslutning (Faktiske)
1. maj 2017
Datoer for studieregistrering
Først indsendt
21. november 2016
Først indsendt, der opfyldte QC-kriterier
22. november 2016
Først opslået (Skøn)
29. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1405004733
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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