NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes (NOURISH)
研究概览
地位
详细说明
Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental non-medical, health-related social need that impacts >20% of pregnant women and up to 50% of individuals with pregestational diabetes in the United States. Nutrition insecurity has devastating health consequences for the >100,000 pregnant women with pregestational diabetes (type 1 or 2) and their exposed infants every year for whom a healthy diet is critical. Pregnant women with pregestational diabetes and nutrition insecurity are more likely to experience poor glycemic control, and as a result, adverse pregnancy outcomes. The risk of these adverse health outcomes increases when glycemic control is not achieved and social needs go unaddressed. Enhancing healthy food access and providing nutrition education-i.e., building "nutrition security"-is critical to improving outcomes for pregnant women with diabetes and poor glycemic control.
Our transdisciplinary team designed NOURISH: a theory- and evidence-based and collaborative healthcare-community partnership to enhance healthy food access, provide nutrition education and support, and address unmet social needs to improve glycemic control and pregnancy outcomes for high-risk pregnant women with pregestational diabetes, poor glycemic control, and food insecurity. The investigators propose the tripartite sustainable NOURISH intervention: 1) weekly nutritious produce home delivery by the Mid-Ohio Farmacy (MOF+), 2) monthly clinic-integrated diabetes, nutrition, and culinary group education by the OSU Cooperative Extension's Dining with Diabetes Program (DWD), and 3) continuous community health worker-led social needs assessment and support by the Health Impact Ohio Central Ohio Pathways Hub (Hub). Our central hypothesis is the combined NOURISH intervention (MOF + DWD + Hub) versus standard care will achieve glycemic control (hemoglobin A1c <6.5% by delivery), prevent adverse pregnancy outcomes (gestational weight gain and neonatal morbidity), and improve diet quality and nutrition security. The investigators will randomize 174 eligible pregnant women (87 NOURISH, 87 standard care) with pregestational diabetes, poor glycemic control, and food insecurity.
The investigators will accomplish three specific aims: 1: use a pragmatic randomized controlled trial to test the effect of NOURISH-enhanced nutrition provision (MOF+), nutrition and diabetes education (DWD), and social needs referrals (Hub)-on improving glycemic control by delivery and secondarily, pregnancy outcomes (maternal gestational weight gain, neonatal morbidity), nutrition quality, and nutrition security.; 2: use cost- effectiveness analysis to assess the NOURISH intervention's value relative to standard care; and 3: use process evaluation to characterize intervention and contextual factors influencing uptake, effectiveness, and sustainability of the NOURISH intervention. NOURISH is a scalable and mutually beneficial healthcare-community partnership to improve nutrition security, glycemic control, and outcomes for pregnant women living with diabetes.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- 招聘中
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
-
接触：
- Kartik Venkatesh, MD, PhD
- 电话号码：614-293-4780
- 邮箱：kartik.venkatesh@osumc.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria:
- Pregnant with singleton or twin pregnancy
- Gestational age >8+0 to ≤22+6 weeks at enrollment by project EDD
- Age ≥ 18 years.
- Type 1 or 2 diabetes.
- Screen positive for food insecurity based on answering "Often" or "Sometimes" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).
- English or Spanish speaking.
- Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.
Hemoglobin A1c criteria:
- If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.
- If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.
Exclusion Criteria
- Involuntarily confined or detained.
- Considered as having a diminished decision-making capacity.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group
Participants in the NOURISH intervention group will be enrolled in the Mid-Ohio Farmacy program to receive home delivery of healthy food and produce from the Mid-Ohio Food Collective up to once a week and access to nutrition education and community resources.
They may be invited to participate in an optional interview about their experience.
Participants will be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy.
|
The Mid-Ohio Food Collective (MOFC) is a regional foodbank that delivers >170,000 meals daily through 680 agency partnerships and is ranked as one of the 10 largest in the U.S.
Both OSUWMC and MOFC are located in a large metropolitan region in Ohio.
OSUWMC offers the Mid-Ohio Farmacy (MOF) referral in nine clinics, including an integrated diabetes and prenatal care clinic for pregnant individuals with pregestational diabetes, with OSUWMC funding secured to continue this program.
The goal of the MOF is to establish a systematic screening and referral process aimed at addressing food insecurity that connects patients to fresh produce through a food pantry near their home.
In NOURISH: The investigators will extend the existing MOF program to weekly home delivery of produce coordinated by the Food Collective.
Weekly MOF+ deliveries will include 15 to 20 pounds per week of low to medium glycemic index fruits and vegetables from available inventory, as recommended by the USDA.
The investigators will deploy OSU Extension's community-based education program, DWD, with live programming focused on cooking instruction from the OSU-based Cooking Matters (CM) program, which actively engages participants to develop skills for healthy eating.
Working with our diabetes education team from DWD, the investigators have tailored this program to target the specific needs of pregnant individuals with pregestational diabetes.
This includes in-person 1 hour group sessions every 4 weeks (monthly) at the time of clinic visits with alternating education sessions provided by DWD with interactive hands-on cooking sessions provided by CM.
The nutrition portion focuses on healthy eating and blood glucose management, and the cooking portion provides education on food safety, knife techniques, nutrition facts and ingredients label reading, meal planning, budgeting, and shopping.
Content will be adapted from state-approved curricula for pregnancy and the American Diabetes Association.
Health Impact Ohio Central Ohio Pathways Hub.
The Pathways Community Hub ('Hub') model consists of three features: (1) the Hub is a regional coordination entity that employs CHWs to assess the medical and social needs of vulnerable patients and connect them to community resources; (2) the CHWs initiate a "care pathway," a defined action plan that describes how patient needs will be addressed, which is then recorded and tracked in an electronic database; and (3) completion of each care pathway is linked to payment from insurance companies (Medicaid-managed care plans and other community partners) based on specific performance benchmarks.
Specifically, a financial contract is attached to each standardized care pathway: When a care pathway is completed, a CHW must confirm that a measurable outcome (e.g., patient is assigned to a medical home) is obtained in order to receive an insurance payment.
|
|
无干预：Standard of care
Participants in the standard of care group will receive access to community resources to support their diet during pregnancy, be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy.
They may be invited to participate in an optional interview about their experience.
Participants will be given access to community resources about nutrition for which they may qualify.
At the completion of the study, participants will be encouraged to enroll and utilize the Mid-Ohio Farmacy program.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
大体时间：Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.
|
The primary outcome of A1c <6.5% versus A1c ≥6.5% will be assessed according to the A1c most proximate to the time of delivery, and is consistent with current clinical guidelines to prevent adverse pregnancy outcomes for the mother and infant.
The frequencies of adverse pregnancy outcomes are significantly decreased with an A1c <6%.
A1c typically will be assessed once per trimester, consistent with guidelines for the management of pregestational diabetes, and at delivery.
The value closest to delivery will be used for participants with >1 A1c value in the third trimester.
The investigators will evaluate A1c using a standard assay and as an absolute percentage of total hemoglobin.
|
Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gestational weight gain (GWG) z-score
大体时间：Time from randomization in the first or second trimester of pregnancy through date of delivery, assessed up to 9 months
|
The secondary outcome of maternal GWG will be defined as the GWG z-score within versus above or below pregnancy recommendations per the Institute of Medicine guidelines.
The Institute of Medicine guidelines for GWG include recommendations specific to pre-pregnancy body mass index (BMI) to optimize maternal and infant outcomes.
The investigators will assess GWG with z-scores (PMID: 34839478).
The investigators will convert absolute weight gain to z-scores using established charts specific to the 4 pre-pregnancy BMI groups and gestational age at delivery.
This GWG z-score is not confounded by duration of pregnancy.
|
Time from randomization in the first or second trimester of pregnancy through date of delivery, assessed up to 9 months
|
|
Composite neonatal outcome
大体时间：Time from delivery or birth of infant to discharge from the hospital, assessed up to 100 weeks
|
The secondary composite neonatal outcome includes one (or more) of the following: large-for-gestational-age at birth, hypoglycemia, hyperbilirubinemia, preterm birth <37 weeks, and neonatal intensive care unit admission.
The individual components will be defined as: 1) Large-for-gestational age: birthweight ≥90th percentile per infant-sex standardized 2017 U.S. reference for singleton birthweight %tile; 2) Hypoglycemia: Capillary glucose <35 mg/dL requiring glucose supplementation <24 hours of birth; 3) Hyperbilirubinemia: Phototherapy without another cause of jaundice; 4) Preterm birth <37 weeks, either spontaneous or medically-indicated; and 5) Neonatal intensive care unit admission for any indication.
|
Time from delivery or birth of infant to discharge from the hospital, assessed up to 100 weeks
|
|
Nutrition security
大体时间：pproximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.
|
The newly developed Gretchen Swanson Center for Nutrition Household Nutrition Security measure consists of 4 questions and is measured on a continuous measure.
This measure aims to determine a household's ability to acquire nutritious foods that meet their health needs without resource challenges or worry.
The measure includes 4 questions, which were scored from 0 to 4, where 4 corresponds to "Always" and 0 corresponds to "Never."
Per the scoring protocol, the investigators will assess this outcome as a continuous measure from 0 to 4 and as a binary variable classifying individuals as "nutrition secure" (average score >2) or "nutrition insecure" (average score ≤2).
|
pproximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.
|
合作者和调查者
调查人员
- 首席研究员：Kartik K Venkatesh, MD, PhD、Ohio State University
- 首席研究员：Daniel Walker, PhD、Ohio State University
- 首席研究员：Christine Field, MD, MPH、Ohio State University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY20260307
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.