Clinical trial NCT06965530: Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
Official title: The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Prematurity
Birth Outcome, Adverse
Keywords: Randomized trial
Behavioral intervention
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University Hospitals Cleveland Medical Center
name: MetroHealth Medical Center
name: Greater Cleveland Food Bank
First posted: 2025-05-11
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Pregnant patients \>10 weeks and \<22 weeks gestation at randomization (must be consented by 20 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

Exclusion Criteria:

* Under 18 years old

Primary outcomes:
measure: Food Insecurity
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Food Insecurity
timeFrame: Change from baseline to 6-months post delivery
measure: Baby Gestational Age
timeFrame: At birth
measure: Baby Birthweight
timeFrame: At birth
measure: Days Hospitalized (Baby)
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 100 months
measure: Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) Utilization
timeFrame: From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months
Secondary outcomes:
measure: Birth Complications
timeFrame: Perioperative/periprocedural
measure: Prenatal Health Care
timeFrame: From first documented prenatal visit until the baby's delivery date, assessed up to 9 months
measure: Pregnancy Complications
timeFrame: Perioperative/periprocedural
measure: Gestational Diabetes Mellitus (GDM)
timeFrame: Assessed up to 40 weeks of pregnancy
measure: Attitudes toward Cooking and Food Preparation
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Attitudes toward Cooking and Food Preparation
timeFrame: Change from baseline to 6-months post delivery
measure: Cooking Efficacy
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Cooking Efficacy
timeFrame: Change from baseline to 6-months post delivery
measure: Cooking Frequency
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Cooking Frequency
timeFrame: Change from baseline to 6-months post delivery
measure: Dietary Quality
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Dietary Quality
timeFrame: Change from baseline to 6-months post delivery
measure: Healthy Eating Index (HEI)
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Healthy Eating Index (HEI)
timeFrame: Change from Baseline to 6 months post-delivery
measure: Healthy Eating Self Efficacy (HESE)
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Healthy Eating Self-Efficacy (HESE)
timeFrame: Change from Baseline to 6 months post-delivery
measure: Depressive Symptoms
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Depressive Symptoms
timeFrame: Change from baseline to 6-months post delivery
measure: Perceived Stress
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Perceived Stress
timeFrame: Change from baseline to 6-months post delivery
measure: Decision Fatigue
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Decision Fatigue
timeFrame: Change from baseline to 6-months post delivery
measure: Social Support
timeFrame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
measure: Social Support
timeFrame: Change from Baseline to 6 months post-delivery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Rainbow Ahuja Women and Children's Center
state: Ohio
city: Cleveland
country: United States
facility: Greater Cleveland Food Bank
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Elaine A Borawski, PhD
role: PRINCIPAL_INVESTIGATOR
References: