NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
研究概览
简要总结
Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of the primary outcome of glycemic control (Hemoglobin A1c) will assessed blinded to study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Involuntarily confined or detained.
- •Considered as having a diminished decision-making capacity.
研究组 & 干预措施
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.
干预措施: Nutrition education with Dining with Diabetes (DWD) (Behavioral)
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.
干预措施: Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs (Behavioral)
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.
干预措施: Mid-Ohio Food Farmacy (MOF+) produce delivery (Dietary Supplement)
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.
结局指标
主要结局
The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
时间窗: 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.
次要结局
- Gestational weight gain (GWG) z-score(Time from randomization in the first or second trimester of pregnancy through date of delivery, assessed up to 9 months)
- Composite neonatal outcome(Time from delivery or birth of infant to discharge from the hospital, assessed up to 100 weeks)
- Nutrition security(pproximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.)
研究者
Kartik K Venkatesh
Principal Investigator
Ohio State University