Addressing Food Insecurity in Pregnancy
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：Janet Lefkowitz, DO
- 電話番号：401-430-2735
- メール：jlefkowitz@kentri.org
研究連絡先のバックアップ
- 名前：Joni Harris, MS
- メール：jonharris@carene.org
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative perceptions of nutritional support and dietary quality among program participants
時間枠：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
時間枠：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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants experiencing delivery-related complications
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Janet Lefkowitz, DO、Women & Infants Hospital
出版物と役立つリンク
一般刊行物
- Augusto 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.
- Ridberg 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.
- Marshall 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.
- 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.
- Stoody 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.
- Ramakrishnan 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.
- Murphy 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.
- Chehab 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.
- Gundersen 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.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- WIH-1921808
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。