跳至主要内容
临床试验/NCT06965530
NCT06965530招募中不适用

The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships

Case Western Reserve University3 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年11月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
3
主要终点
Food Insecurity

研究概览

简要总结

Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.

详细描述

Medically tailored groceries (MTG) generally involve fresh and shelf-stable grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan and are typically picked up at a clinic, market, or pantry. This clinic-based market or pantry model (CB-MTG) is a growing approach adopted by health care systems in their effort to address food insecurity in their patient population, including University Hospitals of Cleveland (UH) and MetroHealth Medical Center (Metro), two of the three largest health systems in Cleveland, Ohio. Often offered to patients with food-related chronic conditions, CB-MTGs have shown to improve medication adherence, increase fruits and vegetable consumption and decrease HbA1c in people with diabetes. However, less evidence is available on the impact of CB-MTGs with food insecure pregnant individuals, where food insecurity has been strongly associated with prematurity and other negative birth outcomes.

While promising, the CB-MTG approach requires transportation, having the tools and equipment to prepare meals at home and some basic food preparation skills, all potential barriers for low-income pregnant individuals, especially younger parents-to-be or those already with children. The Greater Cleveland Food Bank and partners, seeking to address these barriers, recently developed a home delivered version of MTG (HD-MTG), offered to Medicaid-eligible pregnant individuals across the county, with promising results. The investigators seek to integrate these approaches into patient care for food insecure, pregnant women and test the effectiveness of these two approaches, alongside an additional intervention arm that adds supplemental nutrition and culinary education and support to the home-delivered approach (HD-MTG PLUS). These three approaches will be offered (via randomization) to 360 pregnant individuals (120 per arm) with food insecurity who are patients within UH and Metro's largest urban obstetric practices, each with direct electronic health record (EHR) referral systems to their "food as medicine" clinics/markets. Data are collected at baseline, near/at delivery and 6 months post-delivery. This study seeks to understand the unique contribution of each approach, as well as implementation and intervention uptake barriers, with the goal of building the evidence base of MTG interventions and making recommendations to providers and health systems seeking to address food insecurity and nutrient deficiencies during pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years of age and older
  • Pregnant patients >10 weeks and <22 weeks gestation at randomization (must be consented by 18 weeks)
  • Eligible for Medicaid
  • Singleton pregnancy, confirmed by ultrasound
  • An established patient of the UH or Metro pregnancy clinic
  • English speaking
  • Lives in Cuyahoga County, Ohio

排除标准

  • Under 18 years old

研究组 & 干预措施

Clinic-Based Medically Tailored Groceries (CB-MTG)

Active Comparator

Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.

干预措施: Clinic-Based Medically Tailored Groceries (CB-MTG) (Dietary Supplement)

Home Delivered Medically Tailored Groceries (HD-MTG)

Experimental

Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.

干预措施: Home Delivered Medically Tailored Groceries (HD-MTG) (Dietary Supplement)

Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)

Experimental

Same as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.

干预措施: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS) (Dietary Supplement)

结局指标

主要结局

Food Insecurity

时间窗: Change from baseline to 6-months post delivery

6 item, USDA measure; dichotomous outcome

Baby Gestational Age

时间窗: At birth

Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks)

Food Insecurity

时间窗: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome

Baby Birthweight

时间窗: At birth

Measured in grams and classified as normal (\> or = 2500g), low birth weight (\<2500g), very low birthweight (\<1500g), extremely low birth weight (\<1000g)

Days Hospitalized (Baby)

时间窗: From date of birth until the date of discharge from the hospital, assessed up to 100 months

Number of days baby was hospitalized following birth

Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) Utilization

时间窗: From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months

Number of days baby was admitted to NICU or SCN

次要结局

  • Cooking Frequency(Change from baseline to 6-months post delivery)
  • Attitudes toward Cooking and Food Preparation(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Cooking Efficacy(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Cooking Frequency(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Dietary Quality(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Healthy Eating Index (HEI)(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Depressive Symptoms(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Perceived Stress(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Decision Fatigue(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Social Support(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Birth Complications(Perioperative/periprocedural)
  • Prenatal Health Care(From first documented prenatal visit until the baby's delivery date, assessed up to 9 months)
  • Pregnancy Complications(Perioperative/periprocedural)
  • Gestational Diabetes Mellitus (GDM)(Assessed up to 40 weeks of pregnancy)
  • Attitudes toward Cooking and Food Preparation(Change from baseline to 6-months post delivery)
  • Cooking Efficacy(Change from baseline to 6-months post delivery)
  • Dietary Quality(Change from baseline to 6-months post delivery)
  • Healthy Eating Index (HEI)(Change from Baseline to 6 months post-delivery)
  • Healthy Eating Self Efficacy (HESE)(Change from baseline to delivery (assessed up to 40 weeks of pregnancy))
  • Healthy Eating Self-Efficacy (HESE)(Change from Baseline to 6 months post-delivery)
  • Depressive Symptoms(Change from baseline to 6-months post delivery)
  • Perceived Stress(Change from baseline to 6-months post delivery)
  • Decision Fatigue(Change from baseline to 6-months post delivery)
  • Social Support(Change from Baseline to 6 months post-delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine Borawski

Vice Chair for Applied Research, Department of Nutrition

Case Western Reserve University

研究点 (3)

Loading locations...

相似试验

Nourishing Tomorrow: Role of Medically Tailored... | 临床试验