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

November 28, 2016 updated by: Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal clinic in Gulu, Uganda

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Tufts University
Makerere University
Cornell University

Investigators

  • Principal Investigator: Sera L Young, MA, PhD, Northwestern University
  • Principal Investigator: Barnabas K Natamba, MPH, PhD, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1206003141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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