NCT02922829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

September 26, 2016

Last Update Submit

November 28, 2016

Conditions

HIVPregnancy

Keywords

Food InsecurityNutrition

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

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

    Approximately 1 year

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Related Publications (5)

  • Natamba BK, Mehta S, Achan J, Stoltzfus RJ, Griffiths JK, Young SL. The association between food insecurity and depressive symptoms severity among pregnant women differs by social support category: a cross-sectional study. Matern Child Nutr. 2017 Jul;13(3):e12351. doi: 10.1111/mcn.12351. Epub 2016 Aug 9.

    PMID: 27507230BACKGROUND

  • Natamba BK, Kilama H, Arbach A, Achan J, Griffiths JK, Young SL. Reliability and validity of an individually focused food insecurity access scale for assessing inadequate access to food among pregnant Ugandan women of mixed HIV status. Public Health Nutr. 2015 Nov;18(16):2895-905. doi: 10.1017/S1368980014001669. Epub 2014 Aug 29.

    PMID: 25171462BACKGROUND

  • Natamba BK, Achan J, Arbach A, Oyok TO, Ghosh S, Mehta S, Stoltzfus RJ, Griffiths JK, Young SL. Reliability and validity of the center for epidemiologic studies-depression scale in screening for depression among HIV-infected and -uninfected pregnant women attending antenatal services in northern Uganda: a cross-sectional study. BMC Psychiatry. 2014 Nov 22;14:303. doi: 10.1186/s12888-014-0303-y.

    PMID: 25416286BACKGROUND

  • Lane CE, Widen EM, Collins SM, Young SL. HIV-Exposed, Uninfected Infants in Uganda Experience Poorer Growth and Body Composition Trajectories than HIV-Unexposed Infants. J Acquir Immune Defic Syndr. 2020 Oct 1;85(2):138-147. doi: 10.1097/QAI.0000000000002428.

    PMID: 32604132DERIVED

  • Widen EM, Collins SM, Khan H, Biribawa C, Acidri D, Achoko W, Achola H, Ghosh S, Griffiths JK, Young SL. Food insecurity, but not HIV-infection status, is associated with adverse changes in body composition during lactation in Ugandan women of mixed HIV status. Am J Clin Nutr. 2017 Feb;105(2):361-368. doi: 10.3945/ajcn.116.142513. Epub 2017 Jan 4.

    PMID: 28052888DERIVED

Study Officials

  • Sera L Young, MA, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Barnabas K Natamba, MPH, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 4, 2016

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)