An observational study in Food Insecurity and Pregnancy, sponsored by Women and Infants Hospital of Rhode Island. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Women and Infants Hospital of Rhode Island · Observational
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:
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:
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.
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.
Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants identified as food insecure and referred to Social Work for standard assistance.
Participants identified as food insecure and referred to meal supplementation program, based on program availability.
Dietary Supplement: Supplemental meal delivery
Weekly deliveries of supplemental meals to pregnant persons and their households from enrollment until two weeks postpartum.
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.
Time frame: 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).
Time frame: From enrollment through delivery (up to 42 weeks of gestation)
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.
Time frame: At delivery (up to 42 weeks of gestation)
Gestational age at delivery
Gestational age at delivery, measured in completed days.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: At delivery (up to 42 weeks of gestation)
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Jan 2029, 26 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island