NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes (NOURISH)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
-
コンタクト：
- Kartik Venkatesh, MD, PhD
- 電話番号：614-293-4780
- メール：kartik.venkatesh@osumc.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gestational weight gain (GWG) z-score
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Kartik K Venkatesh, MD, PhD、Ohio State University
- 主任研究者：Daniel Walker, PhD、Ohio State University
- 主任研究者：Christine Field, MD, MPH、Ohio State University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY20260307
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?
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
米国で製造され、米国から輸出された製品。
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。