HIVNCT02922829
The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital
An observational study of HIV and Pregnancy, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- How many people
- 403 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal clinic in Gulu, Uganda
Who may be able to join
- Pregnant women
- Known HIV status
- Receiving antiretroviral therapy (if HIV-infected)
- Attending antenatal care at Gulu Regional Referral Hospital
- >18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- Food Insecurity, Nutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 year
Secondary outcomes (1)
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.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Tufts University, Makerere University
- Responsible party
- Sponsor
- Investigators
- Sera L Young, MA, PhD, Principal investigator, Northwestern UniversityBarnabas K Natamba, MPH, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922829
- Sponsor's protocol ID
- 1206003141
- Status last verified
- Nov 2016
- First submitted
- 26 Sep 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27507230Natamba 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.
PubMed 25171462Natamba 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.
PubMed 25416286Lane 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.
PubMed 32604132Widen 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.
PubMed 28052888
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02922829
- Acronym / sponsor ID
- 1206003141
- Keywords
- Food Insecurity, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Cornell University, Tufts University, Makerere University
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal clinic in Gulu, Uganda
Key inclusion criteria (5 listed)
- Pregnant women
- Known HIV status
- Receiving antiretroviral therapy (if HIV-infected)
- Attending antenatal care at Gulu Regional Referral Hospital
- >18 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Impacts of food insecurity on maternal depression among pregnant women of mixed HIV status in Gulu, Uganda.
Time frame: Approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Background: PubMed 27507230Natamba 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.
- Background: PubMed 25171462Natamba 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.
- Background: PubMed 25416286Natamba 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.
- Derived from this study: PubMed 32604132Lane 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.
- Derived from this study: PubMed 28052888Widen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sera L Young, MA, PhD principal investigator
Northwestern University
Barnabas K Natamba, MPH, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pregnancy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922829, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.