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PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda (PostNAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925429
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborators:
Cornell University
Tufts University
Weill Medical College of Cornell University
Makerere University
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal period with the primary scientific objective of determining whether food insecurity was an independent risk factor for poor maternal nutritional or psychosocial outcomes or for sub-optimal infant feeding practices.

Condition or disease
Food Insecurity HIV Maternal and Child Health Nutrition Psychosocial Health

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Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PostNAPS Study: Food Insecurity As A Major Determinant of Poor Nutritional and Psychosocial Health Outcomes Among HIV-Infected and -Uninfected Lactating Women and Their Infants in Gulu, Northern Uganda.
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Impacts of food insecurity (IFIAS) on maternal and infant health indicators (i.e. changes in body composition, hemoglobin, morbidity, etc.) among lactating women of mixed-HIV status and their infants in Gulu, Uganda [ Time Frame: Approximately 1 year ]
    Explore the underlying mechanisms and impacts of food insecurity (using the Individual Food Insecurity Access Scale (IFIAS)) on body composition changes (weight in kg, bioelectrical impedance analysis (among women), skin folds, MUAC), morbidity (malaria, diagnoses or symptoms of fever, typhoid, diarrhea, etc.), micronutrient status (hemoglobin), and other health indicators among women of mixed-HIV status and their infants in Gulu, Uganda.


Secondary Outcome Measures :
  1. Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels among women of mixed-HIV status in Gulu, Uganda. [ Time Frame: Approximately 1 year ]
    Describe the relationship between food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels and assess if these relationships are modified by maternal HIV status.

  2. Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels among women of mixed-HIV status in Gulu, Uganda. [ Time Frame: Approximately 1 year ]
    Describe the relationship between food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels and assess if this relationship is modified by HIV status.

  3. Impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding among women of mixed-HIV status in Gulu, Uganda [ Time Frame: Approximately 1 year ]
    Explore the impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding (breastfeeding, introduction of complimentary foods, infant dietary diversity).

  4. Changes in food insecurity (IFIAS) within the first year of delivery among women of mixed-HIV status in Gulu, Uganda [ Time Frame: Approximately 1 year ]
    Measure changes in the prevalence and severity of food insecurity from delivery to approximately 1 year postpartum among women of mixed-HIV status in Gulu, Uganda.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Postpartum women >18 years of age of mixed HIV status who had attended antenatal care at Gulu Regional Referral Hospital in Gulu, Uganda and had participated in the PreNAPS longitudinal observational cohort study and their infants.
Criteria

Inclusion Criteria:

  • Postpartum women >18 years of age
  • Attended antenatal care at Gulu Regional Referral Hospital
  • Participated in the PreNAPS study
  • Infants that were born to women participating in the PreNAPS study

Exclusion Criteria:

  • Women <18 years of age
  • Women not participating in the PreNAPS study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925429


Sponsors and Collaborators
Northwestern University
Cornell University
Tufts University
Weill Medical College of Cornell University
Makerere University
Investigators
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Principal Investigator: Sera L Young, MA, PhD Northwestern University
Principal Investigator: Barnabas K Natamba, MPH, PhD Michigan State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT02925429    
Other Study ID Numbers: 1302003634
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No