Skip to main content
OpenTrials
Completed

NCT Number: NCT02925429

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Cornell University
  • Makerere University
  • Tufts University
  • Weill Medical College of Cornell University

Registry information

Official study 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.

Acronym: PostNAPS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.