Food InsecurityNCT07918807
Addressing Food Insecurity in Pregnancy
An observational study of Food Insecurity and Pregnancy, run by Women and Infants Hospital of Rhode Island.
Trial summary
The goal of this observational study is to learn if providing meal kits during pregnancy is helpful for people experiencing food insecurity. The study will also learn about participants' experiences with receiving meal kits during pregnancy and after giving birth. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Food Insecurity, Pregnancy
- What is being tested?
- Supplemental meal delivery
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All pregnant persons receiving prenatal care at the OGCC are screened for food insecurity using either the clinic's standard verbiage during the routine social determinants of health screening or the "Hunger Vital Sign" during their routine prenatal visits (including their prenatal intake visit, new OB visit, new High-Risk appointments, or other OB follow up visits). Those who screen positive during one of these visits will be offered enrollment into MoWRI's supplemental nutrition program and this study. Patient who choose to receive meals through MoWRI can opt out of participation in the study. Patients who elect not to receive meals through MoWRI are still eligible to participate in the study.
Who may be able to join
- Pregnant persons aged 18-50 years.
- Receiving prenatal care at the Women \& Infants Hospital of Rhode Island (WIH) Obstetrics \& Gynecology Care Center (OGCC).
- Screen positive for food insecurity.
- Able to give informed consent (interpreter services will be offered for non-English speakers).
- Planning to continue care and deliver at WIH.
Who cannot join
- Plans to relocate or transfer prenatal care outside OGCC before delivery.
- Medical contraindications that would severely alter dietary intake (as assessed by clinician).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Joni Harris, MS contact
About this study
The goal of this observational study is to learn if providing meal kits during pregnancy is helpful for people experiencing food insecurity. The study will also learn about participants' experiences with receiving meal kits during pregnancy and after giving birth. The main questions it aims to answer are:
- Does receiving meal kits affect pregnancy and health outcomes?
- How do participants experience and use the meal kits?
- What benefits or challenges do participants report when receiving the meal kits?
Read more
Participants who screen positive for food insecurity during routine prenatal care will be offered weekly meal kits through Meals on Wheels Rhode Island (MoWRI). Participants who accept the meal program will receive meal kits throughout pregnancy and through two weeks after giving birth. Participants who do not enroll in the meal program will continue to receive their usual prenatal care and referrals to food and nutrition resources.
Participants will:
- Complete surveys about their health, food access, and experiences with the meal program.
- Continue their regular prenatal care.
- Some participants will be invited to complete an interview about their experiences.
Read the detailed description
Food insecurity during pregnancy is associated with adverse maternal and perinatal outcomes and may be an important modifiable social determinant of health. This mixed-methods observational study will evaluate the feasibility, acceptability, and preliminary outcomes associated with providing meal support to pregnant persons experiencing food insecurity who receive prenatal care at the Women \& Infants Hospital of Rhode Island Obstetrics and Gynecology Care Center (OGCC).
All pregnant persons receiving prenatal care at the OGCC are routinely screened for food insecurity as part of social determinants of health screening. Screening may be conducted using the clinic's standard screening language or the Hunger Vital Sign, a validated two-question screening tool derived from the U.S. Household Food Security Survey Module.
- "Within the past 12 months we worried whether our food would run out before we got money to buy more."
- "Within the past 12 months the food we bought just didn't last and we didn't have money to get more."
A response of "sometimes true" or "often true" to either or both questions is considered a positive screen for food insecurity.
Individuals who screen positive for food insecurity during a routine prenatal visit, including prenatal intake, new obstetric visits, new high-risk appointments, or other obstetric follow-up visits, will be offered enrollment in Meals on Wheels Rhode Island (MoWRI). Participants who agree to participate in the meal delivery program will comprise the intervention group. Their contact information will be provided to MoWRI, which will confirm individual and/or household meal needs and arrange delivery of weekly meal kits throughout pregnancy through two weeks postpartum.
Participants who decline or do not enroll in the MoWRI meal program for any reason will comprise the usual-care group. These participants will continue to receive standard prenatal care, including routine nutrition counseling and referrals to community resources such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and other resources available through the OGCC.
Assignment to the intervention or usual-care group will not be randomized. Group assignment will be determined by the participant's decision to accept or decline enrollment in the MoWRI meal program. Participants in both groups will otherwise receive the same routine prenatal medical care, with medical problems documented and managed according to standard clinical practice.
A mixed-methods approach will be used to evaluate participant outcomes and experiences. Quantitative data will be collected through participant surveys and abstraction of relevant information from the medical record. Qualitative data will be collected through participant interviews exploring experiences with food insecurity, the meal program, prenatal care, and perceived benefits or challenges associated with the intervention. Quantitative and qualitative findings will be analyzed in parallel and integrated to provide a comprehensive assessment of the intervention and participant experiences.
- Conditions
- Food Insecurity, Pregnancy
- Being tested
- Supplemental meal delivery
- Keywords
- Meal Supplementation, Food Insecurity in Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental meal deliveryDietary supplement
Weekly deliveries of supplemental meals to pregnant persons and their households from enrollment until two weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Participants identified as food insecure and referred to Social Work for standard assistance. | |
| Intervention with Meal Supplementation | Participants identified as food insecure and referred to meal supplementation program, based on program availability. Receives: Dietary Supplement: Supplemental meal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative perceptions of nutritional support and dietary quality among program participants
Assessment of pregnant patients' experiences, program satisfaction, barriers to food access, and perceived changes in dietary quality resulting from the Meals on Wheels Rhode Island program. Data will be collected via semi-structured qualitative interviews or focus groups with the intervention group. Eligible participants include those who completed the nutritional intervention prior to the interview date. Text data will be transcribed and analyzed using thematic analysis.
Measured: Within 12 months following completion of the nutritional intervention
Proportion of participants experiencing any maternal medical complication
A composite clinical endpoint evaluating overall maternal health complications. A participant will be counted once if they develop at least one of the following clinically diagnosed conditions: gestational diabetes, anemia, chronic hypertension, pulmonary hypertension, gestational hypertension, preeclampsia, or eclampsia. Rates will be compared between the intervention group (receiving meal delivery) and the control group (not receiving meals).
Measured: From enrollment through delivery (up to 42 weeks of gestation)
Secondary outcomes (8)
Proportion of participants experiencing delivery-related complications
The percentage of participants who experience at least one of the following binary (yes/no) labor and delivery events: mode of delivery categorized as cesarean section (vs. vaginal delivery), placental complications (e.g., abruption or previa), clinically documented maternal infections during labor, precipitous labor and delivery (expulsion of the fetus within 3 hours of regular contractions), or an umbilical cord complication.
Measured: At delivery (up to 42 weeks of gestation)
Gestational age at delivery
Gestational age at delivery, measured in completed days.
Measured: At delivery (up to 42 weeks of gestation)
Proportion of neonates with breech or fetal malpresentation
The percentage of neonates presenting in a breech position or other non-vertex fetal malpresentation (yes/no) documented by the clinical team at the time of delivery.
Measured: At delivery (up to 42 weeks of gestation)
Change from baseline in maternal depression symptoms
This outcome tracks maternal mental health metrics over time, comparing the intervention group to the control group. It measures depression symptoms using the Patient Health Questionnaire-9 (PHQ-9) total score (range 0-27, higher scores indicate worse symptoms).
Measured: Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Neonate birth weight
Neonate birth weight, measured continuously in grams.
Measured: At birth (up to 42 weeks of gestation)
Apgar scores
Apgar scores assessed at 1, 5, and 10 minutes after birth. Each score is measured on a standardized scale from 0 to 10, with higher scores indicating better clinical transition.
Measured: 1, 5, and 10 minutes after birth
Change in maternal weight from baseline
This outcome tracks maternal gestational weight gain (measured in kilograms) over time, comparing the intervention group to the control group.
Measured: Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Proportion of participants with a preterm delivery
The percentage of participants who experience a live birth prior to 37 completed weeks of gestation (less than 259 days). Gestational age will be determined based on the first day of the last menstrual period and confirmed by early ultrasound dating. Rates will be compared between the intervention group (receiving MoWRI meal delivery) and the concurrent control group (not receiving meals).
Measured: At delivery (up to 42 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Meals on Wheels of Rhode Island, Harvard Pilgrim Health Care, Point32Health
- Responsible party
- Sponsor
- Investigators
- Janet Lefkowitz, DO, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918807
- Sponsor's protocol ID
- WIH-1921808
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside of the study team. Study data will include information obtained from medical records, participant-completed surveys, and qualitative interviews, including demographic, clinical, pregnancy, delivery, neonatal, and survey data. Interview transcripts will contain participants' open-ended responses to semi-structured interview questions. Data will be stored securely and access will be limited to authorized members of the research team. Because the study collects sensitive health and personal information, IPD will not be made available for sharing outside the institution. Any future data sharing or transfer outside the institution would require appropriate institutional and IRB approval and applicable data-sharing agreements and privacy protections.
Publications
Walker RE, Keane CR, Burke JG. Disparities and access to healthy food in the United States: A review of food deserts literature. Health Place. 2010 Sep;16(5):876-84. doi: 10.1016/j.healthplace.2010.04.013. Epub 2010 Apr 24.
PubMed 20462784Stoody EE, Spahn JM, Casavale KO. The Pregnancy and Birth to 24 Months Project: a series of systematic reviews on diet and health. Am J Clin Nutr. 2019 Mar 1;109(Suppl_7):685S-697S. doi: 10.1093/ajcn/nqy372.
PubMed 30982878Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.
PubMed 35684128Ramakrishnan U, Grant F, Goldenberg T, Zongrone A, Martorell R. Effect of women's nutrition before and during early pregnancy on maternal and infant outcomes: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:285-301. doi: 10.1111/j.1365-3016.2012.01281.x.
PubMed 22742616Murphy LM, Lefkowitz J, Duckworth M, Schlichting L, Tuuli MG, Lewkowitz AK. Pilot study of prenatal community meal supplementation program demonstrates feasibility. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101382. doi: 10.1016/j.ajogmf.2024.101382. Epub 2024 May 16. No abstract available.
PubMed 38761888Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.
PubMed 34968458Augusto ALP, de Abreu Rodrigues AV, Domingos TB, Salles-Costa R. Household food insecurity associated with gestacional and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2020 Apr 17;20(1):229. doi: 10.1186/s12884-020-02917-9.
PubMed 32303221Chehab RF, Croen LA, Laraia BA, Greenberg MB, Ngo AL, Ferrara A, Zhu Y. Food Insecurity in Pregnancy, Receipt of Food Assistance, and Perinatal Complications. JAMA Netw Open. 2025 Jan 2;8(1):e2455955. doi: 10.1001/jamanetworkopen.2024.55955.
PubMed 39847356Gundersen C, Engelhard EE, Crumbaugh AS, Seligman HK. Brief assessment of food insecurity accurately identifies high-risk US adults. Public Health Nutr. 2017 Jun;20(8):1367-1371. doi: 10.1017/S1368980017000180. Epub 2017 Feb 20.
PubMed 28215190
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Food Insecurity in Pregnancy
- ClinicalTrials.gov ID
- NCT07918807
- Acronym / sponsor ID
- WIH-1921808
- Conditions
- Food Insecurity, Pregnancy
- Keywords
- Meal Supplementation, Food Insecurity in Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Meals on Wheels of Rhode Island, Harvard Pilgrim Health Care, Point32Health
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- 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 goal of this observational study is to learn if providing meal kits during pregnancy is helpful for people experiencing food insecurity. The study will also learn about participants' experiences with receiving meal kits during pregnancy and after giving birth. The main questions it aims to answer are:
- Does receiving meal kits affect pregnancy and health outcomes?
- How do participants experience and use the meal kits?
- What benefits or challenges do participants report when receiving the meal kits?
Participants who screen positive for food insecurity during routine prenatal care will be offered weekly meal kits through Meals on Wheels Rhode Island (MoWRI). Participants who accept the meal program will receive meal kits throughout pregnancy and through two weeks after giving birth. Participants who do not enroll in the meal program will continue to receive their usual prenatal care and referrals to food and nutrition resources.
Participants will:
- Complete surveys about their health, food access, and experiences with the meal program.
- Continue their regular prenatal care.
- Some participants will be invited to complete an interview about their experiences.
Detailed description
Food insecurity during pregnancy is associated with adverse maternal and perinatal outcomes and may be an important modifiable social determinant of health. This mixed-methods observational study will evaluate the feasibility, acceptability, and preliminary outcomes associated with providing meal support to pregnant persons experiencing food insecurity who receive prenatal care at the Women \& Infants Hospital of Rhode Island Obstetrics and Gynecology Care Center (OGCC).
All pregnant persons receiving prenatal care at the OGCC are routinely screened for food insecurity as part of social determinants of health screening. Screening may be conducted using the clinic's standard screening language or the Hunger Vital Sign, a validated two-question screening tool derived from the U.S. Household Food Security Survey Module.
- "Within the past 12 months we worried whether our food would run out before we got money to buy more."
- "Within the past 12 months the food we bought just didn't last and we didn't have money to get more."
A response of "sometimes true" or "often true" to either or both questions is considered a positive screen for food insecurity.
Individuals who screen positive for food insecurity during a routine prenatal visit, including prenatal intake, new obstetric visits, new high-risk appointments, or other obstetric follow-up visits, will be offered enrollment in Meals on Wheels Rhode Island (MoWRI). Participants who agree to participate in the meal delivery program will comprise the intervention group. Their contact information will be provided to MoWRI, which will confirm individual and/or household meal needs and arrange delivery of weekly meal kits throughout pregnancy through two weeks postpartum.
Participants who decline or do not enroll in the MoWRI meal program for any reason will comprise the usual-care group. These participants will continue to receive standard prenatal care, including routine nutrition counseling and referrals to community resources such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and other resources available through the OGCC.
Assignment to the intervention or usual-care group will not be randomized. Group assignment will be determined by the participant's decision to accept or decline enrollment in the MoWRI meal program. Participants in both groups will otherwise receive the same routine prenatal medical care, with medical problems documented and managed according to standard clinical practice.
A mixed-methods approach will be used to evaluate participant outcomes and experiences. Quantitative data will be collected through participant surveys and abstraction of relevant information from the medical record. Qualitative data will be collected through participant interviews exploring experiences with food insecurity, the meal program, prenatal care, and perceived benefits or challenges associated with the intervention. Quantitative and qualitative findings will be analyzed in parallel and integrated to provide a comprehensive assessment of the intervention and participant experiences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | –Participants identified as food insecure and referred to Social Work for standard assistance. |
| Intervention with Meal Supplementation | – | Dietary Supplement: Supplemental meal deliveryParticipants identified as food insecure and referred to meal supplementation program, based on program availability. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All pregnant persons receiving prenatal care at the OGCC are screened for food insecurity using either the clinic's standard verbiage during the routine social determinants of health screening or the "Hunger Vital Sign" during their routine prenatal visits (including their prenatal intake visit, new OB visit, new High-Risk appointments, or other OB follow up visits). Those who screen positive during one of these visits will be offered enrollment into MoWRI's supplemental nutrition program and this study. Patient who choose to receive meals through MoWRI can opt out of participation in the study. Patients who elect not to receive meals through MoWRI are still eligible to participate in the study.
Key inclusion criteria (5 listed)
- Pregnant persons aged 18-50 years.
- Receiving prenatal care at the Women \& Infants Hospital of Rhode Island (WIH) Obstetrics \& Gynecology Care Center (OGCC).
- Screen positive for food insecurity.
- Able to give informed consent (interpreter services will be offered for non-English speakers).
- Planning to continue care and deliver at WIH.
Key exclusion criteria (2 listed)
- Plans to relocate or transfer prenatal care outside OGCC before delivery.
- Medical contraindications that would severely alter dietary intake (as assessed by clinician).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental meal deliveryWeekly deliveries of supplemental meals to pregnant persons and their households from enrollment until two weeks postpartum. | Dietary supplement | Intervention with Meal Supplementation |
Primary outcome
Qualitative perceptions of nutritional support and dietary quality among program participants
Time frame: Within 12 months following completion of the nutritional intervention
Assessment of pregnant patients' experiences, program satisfaction, barriers to food access, and perceived changes in dietary quality resulting from the Meals on Wheels Rhode Island program. Data will be collected via semi-structured qualitative interviews or focus groups with the intervention group. Eligible participants include those who completed the nutritional intervention prior to the interview date. Text data will be transcribed and analyzed using thematic analysis.
Proportion of participants experiencing any maternal medical complication
Time frame: From enrollment through delivery (up to 42 weeks of gestation)
A composite clinical endpoint evaluating overall maternal health complications. A participant will be counted once if they develop at least one of the following clinically diagnosed conditions: gestational diabetes, anemia, chronic hypertension, pulmonary hypertension, gestational hypertension, preeclampsia, or eclampsia. Rates will be compared between the intervention group (receiving meal delivery) and the control group (not receiving meals).
8 secondary outcomes
Proportion of participants experiencing delivery-related complications
Time frame: At delivery (up to 42 weeks of gestation)
Gestational age at delivery
Time frame: At delivery (up to 42 weeks of gestation)
Proportion of neonates with breech or fetal malpresentation
Time frame: At delivery (up to 42 weeks of gestation)
Change from baseline in maternal depression symptoms
Time frame: Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Neonate birth weight
Time frame: At birth (up to 42 weeks of gestation)
Apgar scores
Time frame: 1, 5, and 10 minutes after birth
Change in maternal weight from baseline
Time frame: Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Proportion of participants with a preterm delivery
Time frame: At delivery (up to 42 weeks of gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 20462784Walker RE, Keane CR, Burke JG. Disparities and access to healthy food in the United States: A review of food deserts literature. Health Place. 2010 Sep;16(5):876-84. doi: 10.1016/j.healthplace.2010.04.013. Epub 2010 Apr 24.
- Background: PubMed 30982878Stoody EE, Spahn JM, Casavale KO. The Pregnancy and Birth to 24 Months Project: a series of systematic reviews on diet and health. Am J Clin Nutr. 2019 Mar 1;109(Suppl_7):685S-697S. doi: 10.1093/ajcn/nqy372.
- Background: PubMed 35684128Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.
- Background: PubMed 22742616Ramakrishnan U, Grant F, Goldenberg T, Zongrone A, Martorell R. Effect of women's nutrition before and during early pregnancy on maternal and infant outcomes: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:285-301. doi: 10.1111/j.1365-3016.2012.01281.x.
- Background: PubMed 38761888Murphy LM, Lefkowitz J, Duckworth M, Schlichting L, Tuuli MG, Lewkowitz AK. Pilot study of prenatal community meal supplementation program demonstrates feasibility. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101382. doi: 10.1016/j.ajogmf.2024.101382. Epub 2024 May 16. No abstract available.
- Background: PubMed 34968458Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.
- Background: PubMed 32303221Augusto ALP, de Abreu Rodrigues AV, Domingos TB, Salles-Costa R. Household food insecurity associated with gestacional and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2020 Apr 17;20(1):229. doi: 10.1186/s12884-020-02917-9.
- Background: PubMed 39847356Chehab RF, Croen LA, Laraia BA, Greenberg MB, Ngo AL, Ferrara A, Zhu Y. Food Insecurity in Pregnancy, Receipt of Food Assistance, and Perinatal Complications. JAMA Netw Open. 2025 Jan 2;8(1):e2455955. doi: 10.1001/jamanetworkopen.2024.55955.
- Background: PubMed 28215190Gundersen C, Engelhard EE, Crumbaugh AS, Seligman HK. Brief assessment of food insecurity accurately identifies high-risk US adults. Public Health Nutr. 2017 Jun;20(8):1367-1371. doi: 10.1017/S1368980017000180. Epub 2017 Feb 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside of the study team. Study data will include information obtained from medical records, participant-completed surveys, and qualitative interviews, including demographic, clinical, pregnancy, delivery, neonatal, and survey data. Interview transcripts will contain participants' open-ended responses to semi-structured interview questions. Data will be stored securely and access will be limited to authorized members of the research team. Because the study collects sensitive health and personal information, IPD will not be made available for sharing outside the institution. Any future data sharing or transfer outside the institution would require appropriate institutional and IRB approval and applicable data-sharing agreements and privacy protections.
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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.
Joni Harris, MS contact
Janet Lefkowitz, DO principal investigator
Women & Infants Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity and Pregnancy, run by Women and Infants Hospital of Rhode Island.
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 2 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Lefkowitz, DO (401-430-2735, jlefkowitz@kentri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative perceptions of nutritional support and dietary quality among program participants (time frame: Within 12 months following completion of the nutritional intervention). The study lists 2 primary outcomes in all. 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 NCT07918807, which also lists 9 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 5 Nov 2026.