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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR021490 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| University Hospitals Cleveland Medical Center | OTHER |
| MetroHealth Medical Center | OTHER |
| Greater Cleveland Food Bank |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-Based Medically Tailored Groceries (CB-MTG) | Active Comparator | Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Insecurity | 6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome | Change from baseline to delivery (assessed up to 40 weeks of pregnancy) |
| Food Insecurity | 6 item, USDA measure; dichotomous outcome | Change from baseline to 6-months post delivery |
| Baby Gestational Age | Measured in weeks and classified as preterm (<37 weeks) vs. term (37+ weeks) | 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) | At birth |
| Days Hospitalized (Baby) | Number of days baby was hospitalized following birth | 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 | From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Complications | List of poor maternal and fetal health conditions or outcomes at time of delivery | Perioperative/periprocedural |
| Prenatal Health Care | Number / Frequency of prenatal health care visits, extracted from medical record (chart review) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Bentley, MPH | Contact | 216-368-1024 | sxb1213@case.edu | |
| Elaine A Borawski, PhD | Contact | 216-368-1024 | exb11@case.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elaine A Borawski, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
As required by our National Institute of Nursing Research grant award, please see the required Data Management and Sharing Plan (uploaded as separate document). In brief, at the of the study, de-identified questionnaire, clinical and implementation data will be deposited into the Inter-university Consortium for Political and Social Research (ICPSR) and designated as controlled access. Case Western Reserve University (CWRU) is a member of ICPSR which permits the deposit of data at no charge.
Within 6 months of the primary outcomes paper being published.
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| 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. |
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| 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 | Perioperative/periprocedural |
| Gestational Diabetes Mellitus (GDM) | Diagnosis of GDM during pregnancy | 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 | 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 | 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). | 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | Change from Baseline to 6 months post-delivery |
| University Hospitals Rainbow Ahuja Women and Children's Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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