Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02922829
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborators:
Cornell University
Tufts University
Makerere University
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
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.

Condition or disease
HIV Pregnancy

Layout table for study information
Study Type : Observational
Actual Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal clinic in Gulu, Uganda
Criteria

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

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): NCT02922829


Locations
Layout table for location information
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
Sponsors and Collaborators
Northwestern University
Cornell University
Tufts University
Makerere University
Investigators
Layout table for investigator information
Principal Investigator: Sera L Young, MA, PhD Northwestern University
Principal Investigator: Barnabas K Natamba, MPH, PhD Michigan State University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT02922829    
Other Study ID Numbers: 1206003141
First Posted: October 4, 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
Keywords provided by Northwestern University:
Food Insecurity
Nutrition