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Addressing Food Insecurity in Pregnancy

2026년 11월 3일 업데이트: Women and Infants Hospital of Rhode Island

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

  1. "Within the past 12 months we worried whether our food would run out before we got money to buy more."
  2. "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.

연구 유형

관찰

등록 (추정된)

700

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Plans to relocate or transfer prenatal care outside OGCC before delivery.
  • Medical contraindications that would severely alter dietary intake (as assessed by clinician).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.

Weekly deliveries of supplemental meals to pregnant persons and their households from enrollment until two weeks postpartum.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Qualitative perceptions of nutritional support and dietary quality among program participants
기간: 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.

Within 12 months following completion of the nutritional intervention
Proportion of participants experiencing any maternal medical complication
기간: 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).

From enrollment through delivery (up to 42 weeks of gestation)

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of participants experiencing delivery-related complications
기간: 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.

At delivery (up to 42 weeks of gestation)
Gestational age at delivery
기간: At delivery (up to 42 weeks of gestation)

Gestational age at delivery, measured in completed days.

At delivery (up to 42 weeks of gestation)
Proportion of neonates with breech or fetal malpresentation
기간: 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.

At delivery (up to 42 weeks of gestation)
Change from baseline in maternal depression symptoms
기간: 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).

Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Neonate birth weight
기간: At birth (up to 42 weeks of gestation)

Neonate birth weight, measured continuously in grams.

At birth (up to 42 weeks of gestation)
Apgar scores
기간: 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.

1, 5, and 10 minutes after birth
Change in maternal weight from baseline
기간: 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.

Baseline (Prenatal Intake or New OB visit, whichever comes first) to approximately 6 weeks postpartum
Proportion of participants with a preterm delivery
기간: 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).

At delivery (up to 42 weeks of gestation)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Janet Lefkowitz, DO, Women & Infants Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2026년 8월 19일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • WIH-1921808

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .