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Completed

NCT Number: NCT02922829

The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital

The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's primary goals were: a) to determine the differential impacts of food insecurity on gestational weight gain and prenatal depression, and b) to elucidate the mechanisms underlying the relationship between food insecurity and weight gain and/depression among HIV infected and HIV uninfected pregnant women in Gulu, Northern Uganda.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern University

Evanston, Illinois, 60208, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women
  • Known HIV status
  • Receiving antiretroviral therapy (if HIV-infected)
  • Attending antenatal care at Gulu Regional Referral Hospital
  • >18 years of age

Exclusion criteria

  • Pregnant women <18 years of age
  • Unknown HIV status
  • Not receiving antiretroviral therapy (if HIV-infected)
  • Not attending antenatal care at Gulu Regional Referral Hospital

Treatment and study plan

Primary outcomes

  1. Impacts of food insecurity (IFIAS) on gestational weight gain (kg) among pregnant women of mixed HIV status in Gulu, Uganda

    Time frame: Approximately 1 year

    Explore the underlying mechanisms and impacts of food insecurity (using the Individuals Food Insecurity Access Scale (IFIAS)) on gestational weight gain (kg) among pregnant women of mixed HIV status in Gulu, Uganda.

Secondary outcomes

  1. Impacts of food insecurity on maternal depression among pregnant women of mixed HIV status in Gulu, Uganda.

    Time frame: Approximately 1 year

    Explore the underlying mechanisms and impacts of food insecurity on maternal depressive symptoms among pregnant women of mixed HIV status in Gulu, Uganda.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Cornell University
  • Makerere University
  • Tufts University

Registry information

Official study title

The PreNAPS Study: Food Insecurity, Prenatal Nutrition, and Psychosocial Health Outcomes Among HIV Infected and Uninfected Pregnant Women Attending ANC Services at Gulu Regional Referral Hospital

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 4, 2016
Registry last updated
Nov 30, 2016

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.

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