Clinical trial NCT02922829: The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Pregnancy
Keywords: Food Insecurity
Nutrition
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Tufts University
name: Makerere University
First posted: 2016-10-04
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal clinic in Gulu, Uganda

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.


Eligibility 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

Primary outcomes:
measure: Impacts of food insecurity (IFIAS) on gestational weight gain (kg) among pregnant women of mixed HIV status in Gulu, Uganda
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Impacts of food insecurity on maternal depression among pregnant women of mixed HIV status in Gulu, Uganda.
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Sera L Young, MA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Barnabas K Natamba, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.