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NCT Number: NCT06965530

Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy

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.

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Key information

Conditions

Pregnancy Related Birth Outcome, Adverse Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Under 18 years old

Treatment and study plan

Clinic-Based Medically Tailored Groceries (CB-MTG)

Dietary Supplement

Patients have the opportunity to pick up medically tailored groceries every other week at the Food Is Medicine Clinic or Market associated with their provider.

Home Delivered Medically Tailored Groceries (HD-MTG)

Dietary Supplement

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

Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)

Dietary Supplement

Patients receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, plus also receives additional nutrition and culinary education and support throughout the trial.

Primary outcomes

  1. Food Insecurity

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

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

  2. Food Insecurity

    Time frame: Change from baseline to 6-months post delivery

    6 item, USDA measure; dichotomous outcome

  3. Baby Gestational Age

    Time frame: At birth

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

  4. Baby Birthweight

    Time frame: At birth

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

  5. Days Hospitalized (Baby)

    Time frame: 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

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

    Time frame: 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

Secondary outcomes

  1. Birth Complications

    Time frame: Perioperative/periprocedural

    List of poor maternal and fetal health conditions or outcomes at time of delivery

  2. Prenatal Health Care

    Time frame: From first documented prenatal visit until the baby's delivery date, assessed up to 9 months

    Number / Frequency of prenatal health care visits, extracted from medical record (chart review)

  3. Pregnancy Complications

    Time frame: Perioperative/periprocedural

    Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy

  4. Gestational Diabetes Mellitus (GDM)

    Time frame: Assessed up to 40 weeks of pregnancy

    Diagnosis of GDM during pregnancy

  5. Attitudes toward Cooking and Food Preparation

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking

  6. Attitudes toward Cooking and Food Preparation

    Time frame: Change from baseline to 6-months post delivery

    Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking

  7. Cooking Efficacy

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Mean of 4 items, range 1-5 (not all at confident to extremely confident); higher number indicates higher efficacy; e.g. I can cook nutritious meal; I can cook a meal in a short amount of time; I can cook a nutritious meal without spending a lot of money; I can follow a recipe).

  8. Cooking Efficacy

    Time frame: Change from baseline to 6-months post delivery

    Mean of 4 items, range 1-5 (not all at confident to extremely confident); higher number indicates higher efficacy; e.g. I can cook nutritious meal; I can cook a meal in a short amount of time; I can cook a nutritious meal without spending a lot of money; I can follow a recipe).

  9. Cooking Frequency

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    3 items; from National Health and Nutrition Examination Survey (NHNES); # of times a week cooking breakfast, lunch and dinner

  10. Cooking Frequency

    Time frame: Change from baseline to 6-months post delivery

    3 items; from NHNES; # of times a week cooking breakfast, lunch and dinner

  11. Dietary Quality

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Derived from diet recalls collected with the Nutrition Data System for Research. Includes: total calories, energy density, macronutrient intake, micronutrients, dietary fiber, sugar sweetened beverages, food group intake, and fast food intake

  12. Dietary Quality

    Time frame: Change from baseline to 6-months post delivery

    Derived from diet recalls collected with the Nutrition Data System for Research. Includes: total calories, energy density, macronutrient intake, micronutrients, dietary fiber, sugar sweetened beverages, food group intake, and fast food intake

  13. Healthy Eating Index (HEI)

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet

  14. Healthy Eating Index (HEI)

    Time frame: Change from Baseline to 6 months post-delivery

    Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet

  15. Healthy Eating Self Efficacy (HESE)

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Subscale of the Healthy Eating and Weight Self-Efficacy Scale: Mean of 6 items, range 1-5, higher scores indicate higher level of confidence to choose, prepare and consume healthy food options

  16. Healthy Eating Self-Efficacy (HESE)

    Time frame: Change from Baseline to 6 months post-delivery

    Subscale of the Healthy Eating and Weight Self-Efficacy Scale: Mean of 6 items, range 1-5, higher scores indicate higher level of confidence to choose, prepare and consume healthy food options

  17. Depressive Symptoms

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Edinburgh Perinatal / Postnatal Depression Scale (EDPS); a 10-question survey with each answer given a score of 0-3; higher scores suggest minor or major depression may be present

  18. Depressive Symptoms

    Time frame: Change from baseline to 6-months post delivery

    Edinburgh Perinatal / Postnatal Depression Scale (EDPS); a 10-question survey with each answer given a score of 0-3; higher scores suggest minor or major depression may be present

  19. Perceived Stress

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Mother's stress index score (10-item standardized index, with each answer given a score of 1-5 and higher scores indicating stress is present)

  20. Perceived Stress

    Time frame: Change from baseline to 6-months post delivery

    Mother's stress index score (10-item standardized index, with each answer given a score of 1-5 and higher scores indicating stress is present)

  21. Decision Fatigue

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)

  22. Decision Fatigue

    Time frame: Change from baseline to 6-months post delivery

    Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)

  23. Social Support

    Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)

    Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support

  24. Social Support

    Time frame: Change from Baseline to 6 months post-delivery

    Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine A Borawski, PhD

CONTACT

[email protected]

216-368-1024

Samantha Bentley, MPH

CONTACT

[email protected]

216-368-1024

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Greater Cleveland Food Bank
  • MetroHealth Medical Center
  • National Institute of Nursing Research (NINR)
  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 11, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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