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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922829
• Other study ID #: 1206003141
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: November 28, 2016
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: National Council for Science and Technology
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV
• Pregnancy

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Cornell University, Makerere University, Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. 2016 Aug 9. doi: 10.1111/mcn.12351. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Impacts of food insecurity on maternal depression among pregnant women of mixed HIV status in Gulu, Uganda.	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	No