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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
360
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.
Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery.
Patients receive home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery, plus also receives additional nutrition and culinary education and support throughout the trial.
MetroHealth Medical Center
Cleveland, Ohio, United States
RECRUITINGUniversity Hospitals Rainbow Ahuja Women and Children's Center
Cleveland, Ohio, United States
RECRUITINGFood Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Food Insecurity
6 item, USDA measure; dichotomous outcome
Time frame: Change from baseline to 6-months post delivery
Baby Gestational Age
Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks)
Time frame: At birth
Baby Birthweight
Measured in grams and classified as normal (\> or = 2500g), low birth weight (\<2500g), very low birthweight (\<1500g), extremely low birth weight (\<1000g)
Time frame: At birth
Days Hospitalized (Baby)
Number of days baby was hospitalized following birth
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 100 months
Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) Utilization
Number of days baby was admitted to NICU or SCN
Time frame: From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months
Birth Complications
List of poor maternal and fetal health conditions or outcomes at time of delivery
Time frame: Perioperative/periprocedural
Prenatal Health Care
Number / Frequency of prenatal health care visits, extracted from medical record (chart review)
Time frame: From first documented prenatal visit until the baby's delivery date, assessed up to 9 months
Pregnancy Complications
Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy
Time frame: Perioperative/periprocedural
Gestational Diabetes Mellitus (GDM)
Diagnosis of GDM during pregnancy
Time frame: Assessed up to 40 weeks of pregnancy
Attitudes toward Cooking and Food Preparation
Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Attitudes toward Cooking and Food Preparation
Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking
Time frame: Change from baseline to 6-months post delivery
Cooking Efficacy
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).
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Cooking Efficacy
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).
Time frame: Change from baseline to 6-months post delivery
Cooking Frequency
3 items; from National Health and Nutrition Examination Survey (NHNES); # of times a week cooking breakfast, lunch and dinner
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Cooking Frequency
3 items; from NHNES; # of times a week cooking breakfast, lunch and dinner
Time frame: Change from baseline to 6-months post delivery
Dietary Quality
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
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Dietary Quality
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
Time frame: Change from baseline to 6-months post delivery
Healthy Eating Index (HEI)
Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Healthy Eating Index (HEI)
Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet
Time frame: Change from Baseline to 6 months post-delivery
Healthy Eating Self Efficacy (HESE)
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
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Healthy Eating Self-Efficacy (HESE)
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
Time frame: Change from Baseline to 6 months post-delivery
Depressive Symptoms
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
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Depressive Symptoms
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
Time frame: Change from baseline to 6-months post delivery
Perceived Stress
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)
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Perceived Stress
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)
Time frame: Change from baseline to 6-months post delivery
Decision Fatigue
Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Decision Fatigue
Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)
Time frame: Change from baseline to 6-months post delivery
Social Support
Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Social Support
Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support
Time frame: Change from Baseline to 6 months post-delivery
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