Birth Outcome, Adverse, Pregnancy Related, Prematurity
Conditions
Keywords
Randomized trial, Behavioral intervention
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.
Interventions
DIETARY_SUPPLEMENTClinic-Based Medically Tailored Groceries (CB-MTG)
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.
DIETARY_SUPPLEMENTHome Delivered Medically Tailored Groceries (HD-MTG)
Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
DIETARY_SUPPLEMENTHome Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)
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.
Sponsors
Case Western Reserve University
National Institute of Nursing Research (NINR)
University Hospitals Cleveland Medical Center
MetroHealth Medical Center
Greater Cleveland Food Bank
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Insecurity | Change from baseline to delivery (assessed up to 40 weeks of pregnancy) | 6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome |
| Baby Gestational Age | At birth | Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks) |
| Baby Birthweight | 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Birth Complications | Perioperative/periprocedural | List of poor maternal and fetal health conditions or outcomes at time of delivery |
| Prenatal Health Care | 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) |
| Pregnancy Complications | Perioperative/periprocedural | Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy |
| Gestational Diabetes Mellitus (GDM) | Assessed up to 40 weeks of pregnancy | Diagnosis of GDM during pregnancy |
| Attitudes toward Cooking and Food Preparation | 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 |
| Cooking Efficacy | 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). |
| Cooking Frequency | 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 |
| Dietary Quality | 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 |
| Healthy Eating Index (HEI) | 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 |
| Healthy Eating Self Efficacy (HESE) | 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 |
| Healthy Eating Self-Efficacy (HESE) | 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 |
| Depressive Symptoms | 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 |
| Perceived Stress | 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) |
| Decision Fatigue | 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) |
| Social Support | 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 |
Countries
United States
Contacts
CONTACTSamantha Bentley, MPH
CONTACTElaine A Borawski, PhD
PRINCIPAL_INVESTIGATORElaine A Borawski, PhD
Case Western Reserve University
Outcome results
None listed