NCT02925429

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

October 3, 2016

Last Update Submit

November 10, 2020

Conditions

Food InsecurityHIVMaternal and Child HealthNutritionPsychosocial Health

Outcome Measures

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

    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.

    Approximately 1 year

Secondary Outcomes (4)

  • Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels among women of mixed-HIV status in Gulu, Uganda.

    Approximately 1 year

  • Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels among women of mixed-HIV status in Gulu, Uganda.

    Approximately 1 year

  • Impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding among women of mixed-HIV status in Gulu, Uganda

    Approximately 1 year

  • Changes in food insecurity (IFIAS) within the first year of delivery among 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

Postpartum women \>18 years of age of mixed HIV status who had attended antenatal care at Gulu Regional Referral Hospital in Gulu, Uganda and had participated in the PreNAPS longitudinal observational cohort study and their infants.

You may qualify if:

  • 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

You may not qualify if:

  • Women \<18 years of age
  • Women not participating in the PreNAPS study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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

  • Boateng GO, Martin SL, Tuthill EL, Collins SM, Dennis CL, Natamba BK, Young SL. Adaptation and psychometric evaluation of the breastfeeding self-efficacy scale to assess exclusive breastfeeding. BMC Pregnancy Childbirth. 2019 Feb 18;19(1):73. doi: 10.1186/s12884-019-2217-7.

    PMID: 30777020DERIVED

  • Boateng GO, Martin SL, Collins SM, Natamba BK, Young SL. Measuring exclusive breastfeeding social support: Scale development and validation in Uganda. Matern Child Nutr. 2018 Jul;14(3):e12579. doi: 10.1111/mcn.12579. Epub 2018 Jan 22.

    PMID: 29356347DERIVED

  • 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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share