<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02974972</url>
  </required_header>
  <id_info>
    <org_study_id>1405004733</org_study_id>
    <nct_id>NCT02974972</nct_id>
  </id_info>
  <brief_title>Pith Moromo 2: Cohort to Study Health Consequences of Food and Nutrition Insecurity During Pregnancy and Lactation</brief_title>
  <acronym>PM2</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators conducted research among HIV-infected and -uninfected&#xD;
      pregnant and lactating women to understand the potential role and importance of food&#xD;
      insecurity on participant physical and psychosocial health and nutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The central hypothesis of this study was that food and nutrition insecurity are detrimental&#xD;
      to the health of HIV+ pregnant women and their infants via nutritional, disease, and&#xD;
      psychosocial pathways.&#xD;
&#xD;
      In the first phase, the investigators collected descriptive data to describe and assess food&#xD;
      and nutrition insecurity and the associated modifiable determinants among HIV+ pregnant and&#xD;
      lactating women in Kenya.&#xD;
&#xD;
      In the second phase, the investigators collected longitudinal cohort data from women who were&#xD;
      recruited during pregnancy and have been followed throughout the infant's first year of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the Impact of Livestock Ownership on Maternal and Child Health Using Photovoice Qualitative Data Collection Methodology</measure>
    <time_frame>1 year</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">371</enrollment>
  <condition>Food Insecurity</condition>
  <condition>Nutrition</condition>
  <condition>Maternal and Child Health</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Pith Moromo 2 Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of 371 pregnant HIV-infected and -uninfected women (ratio 1:1) were recruited from&#xD;
        7 rural and urban clinics in Nyanza, Kenya. Participants were followed from ≤30 weeks&#xD;
        pregnancy until 9 months postpartum.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women &gt;18 years of age with infants&#xD;
&#xD;
          -  Infants born to pregnant women enrolled in the cohort study&#xD;
&#xD;
          -  HIV-infected pregnant women &gt;18 years of age and ≤30 weeks gestation&#xD;
&#xD;
          -  HIV-uninfected pregnant women &gt;18 years of age and ≤30 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals &lt;18 years of age that are not infants born to women enrolled in the cohort&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <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. 2020 Jun;24(6):1632-1642. doi: 10.1007/s10461-019-02676-5.</citation>
    <PMID>31538283</PMID>
  </results_reference>
  <results_reference>
    <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 Oct;24(10):2885-2894. doi: 10.1007/s10461-020-02839-9.</citation>
    <PMID>32212069</PMID>
  </results_reference>
  <results_reference>
    <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 Nutr. 2019 Mar;73(3):474-482. doi: 10.1038/s41430-018-0285-9. Epub 2018 Sep 5.</citation>
    <PMID>30185898</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31333167</PMID>
  </results_reference>
  <results_reference>
    <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 observational study. Int Breastfeed J. 2020 Jan 16;15(1):4. doi: 10.1186/s13006-019-0251-8.</citation>
    <PMID>31948438</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>32184035</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Sera Young</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02974972
org study id: 1405004733
nct id: NCT02974972
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: 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.
measure: 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
description: 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.
measure: Assessing the Impact of Livestock Ownership on Maternal and Child Health Using Photovoice Qualitative Data Collection Methodology
time frame: 1 year
description: 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).
arm group label: Pith Moromo 2 Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 1 Day
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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. 2020 Jun;24(6):1632-1642. doi: 10.1007/s10461-019-02676-5.
PMID: 31538283
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 Oct;24(10):2885-2894. doi: 10.1007/s10461-020-02839-9.
PMID: 32212069
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 Nutr. 2019 Mar;73(3):474-482. doi: 10.1038/s41430-018-0285-9. Epub 2018 Sep 5.
PMID: 30185898
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.
PMID: 31333167
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 observational study. Int Breastfeed J. 2020 Jan 16;15(1):4. doi: 10.1186/s13006-019-0251-8.
PMID: 31948438
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Sera Young
investigator title: Assistant Professor