Addressing Food Insecurity in Pregnancy
NCT07918807, Not yet recruiting, Women and Infants Hospital of Rhode Island
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Addressing Food Insecurity in Pregnancy | ClinicalTrials.gov |
| NCT number | NCT07918807 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 700 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Women and Infants Hospital of Rhode Island | ClinicalTrials.gov |
| Conditions | Food Insecurity, Pregnancy | ClinicalTrials.gov |
| Interventions | Supplemental meal delivery | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Qualitative perceptions of nutritional support and dietary quality among program participants | 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. | ClinicalTrials.gov |
| Primary | Proportion of participants experiencing any maternal medical complication | 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). | ClinicalTrials.gov |
| Secondary | Proportion of participants experiencing delivery-related complications | At delivery (up to 42 weeks of gestation) | 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. | ClinicalTrials.gov |
| Secondary | Gestational age at delivery | At delivery (up to 42 weeks of gestation) | Gestational age at delivery, measured in completed days. | ClinicalTrials.gov |
| Secondary | Proportion of neonates with breech or fetal malpresentation | At delivery (up to 42 weeks of gestation) | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in maternal depression symptoms | Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum | 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). | ClinicalTrials.gov |
| Secondary | Neonate birth weight | At birth (up to 42 weeks of gestation) | Neonate birth weight, measured continuously in grams. | ClinicalTrials.gov |
| Secondary | Apgar scores | 1, 5, and 10 minutes after birth | 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. | ClinicalTrials.gov |
| Secondary | Change in maternal weight from baseline | Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum | This outcome tracks maternal gestational weight gain (measured in kilograms) over time, comparing the intervention group to the control group. | ClinicalTrials.gov |
| Secondary | Proportion of participants with a preterm delivery | At delivery (up to 42 weeks of gestation) | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)