[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06965530":3,"trial-entities:NCT06965530":183,"trial-summary:NCT06965530":187},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":70,"sex":129,"minimum_age":130,"maximum_age":131,"healthy_volunteers":15,"eligibility_criteria":132,"std_ages":144,"locations":146,"central_contacts":170,"overall_officials":178,"references":181,"see_also_links":182},"NCT06965530","STUDY20241029","Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy","The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships","RECRUITING","2029-05-31","2026-04","2026-04-20","2025-11-12","Case Western Reserve University","OTHER",true,"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.\n\nWhile 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\u002Fmarkets. Data are collected at baseline, near\u002Fat 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.",[19,20,21],"Pregnancy Related","Prematurity","Birth Outcome, Adverse",[23,24],"Randomized trial","Behavioral intervention","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},360,"ESTIMATED",[33,38,42],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Clinic-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.",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Home 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.",[39],{"type":34,"name":43,"description":44,"armGroupLabels":45},"Home 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.",[46],"Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)",[48,52,55,59,62,66],{"measure":49,"description":50,"timeFrame":51},"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)",{"measure":49,"description":53,"timeFrame":54},"6 item, USDA measure; dichotomous outcome","Change from baseline to 6-months post delivery",{"measure":56,"description":57,"timeFrame":58},"Baby Gestational Age","Measured in weeks and classified as preterm (\\\u003C37 weeks) vs. term (37+ weeks)","At birth",{"measure":60,"description":61,"timeFrame":58},"Baby Birthweight","Measured in grams and classified as normal (\\> or = 2500g), low birth weight (\\\u003C2500g), very low birthweight (\\\u003C1500g), extremely low birth weight (\\\u003C1000g)",{"measure":63,"description":64,"timeFrame":65},"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",{"measure":67,"description":68,"timeFrame":69},"Neonatal Intensive Care Unit (NICU)\u002FSpecial Care Nursery (SCN) Utilization","Number of days baby was admitted to NICU or SCN","From admission date to the NICU\u002FSCN until the date of discharge from NICU\u002FSCN, assessed up to 100 months",[71,75,79,82,86,89,90,93,94,97,99,102,103,106,108,111,113,116,117,120,121,124,125,128],{"measure":72,"description":73,"timeFrame":74},"Birth Complications","List of poor maternal and fetal health conditions or outcomes at time of delivery","Perioperative\u002Fperiprocedural",{"measure":76,"description":77,"timeFrame":78},"Prenatal Health Care","Number \u002F Frequency of prenatal health care visits, extracted from medical record (chart review)","From first documented prenatal visit until the baby's delivery date, assessed up to 9 months",{"measure":80,"description":81,"timeFrame":74},"Pregnancy Complications","Yes \u002F No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy",{"measure":83,"description":84,"timeFrame":85},"Gestational Diabetes Mellitus (GDM)","Diagnosis of GDM during pregnancy","Assessed up to 40 weeks of pregnancy",{"measure":87,"description":88,"timeFrame":51},"Attitudes toward Cooking and Food Preparation","Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking",{"measure":87,"description":88,"timeFrame":54},{"measure":91,"description":92,"timeFrame":51},"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).",{"measure":91,"description":92,"timeFrame":54},{"measure":95,"description":96,"timeFrame":51},"Cooking Frequency","3 items; from National Health and Nutrition Examination Survey (NHNES); # of times a week cooking breakfast, lunch and dinner",{"measure":95,"description":98,"timeFrame":54},"3 items; from NHNES; # of times a week cooking breakfast, lunch and dinner",{"measure":100,"description":101,"timeFrame":51},"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",{"measure":100,"description":101,"timeFrame":54},{"measure":104,"description":105,"timeFrame":51},"Healthy Eating Index (HEI)","Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet",{"measure":104,"description":105,"timeFrame":107},"Change from Baseline to 6 months post-delivery",{"measure":109,"description":110,"timeFrame":51},"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",{"measure":112,"description":110,"timeFrame":107},"Healthy Eating Self-Efficacy (HESE)",{"measure":114,"description":115,"timeFrame":51},"Depressive Symptoms","Edinburgh Perinatal \u002F 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",{"measure":114,"description":115,"timeFrame":54},{"measure":118,"description":119,"timeFrame":51},"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)",{"measure":118,"description":119,"timeFrame":54},{"measure":122,"description":123,"timeFrame":51},"Decision Fatigue","Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)",{"measure":122,"description":123,"timeFrame":54},{"measure":126,"description":127,"timeFrame":51},"Social Support","Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support",{"measure":126,"description":127,"timeFrame":107},"FEMALE","18 Years","55 Years",{"inclusion":133,"exclusion":141,"raw_text":143},[134,135,136,137,138,139,140],"18 years of age and older","Pregnant patients \\>10 weeks and \\\u003C22 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",[142],"Under 18 years old","Inclusion Criteria:\n\n* 18 years of age and older\n* Pregnant patients \\>10 weeks and \\\u003C22 weeks gestation at randomization (must be consented by 18 weeks)\n* Eligible for Medicaid\n* Singleton pregnancy, confirmed by ultrasound\n* An established patient of the UH or Metro pregnancy clinic\n* English speaking\n* Lives in Cuyahoga County, Ohio\n\nExclusion Criteria:\n\n* Under 18 years old",[145],"ADULT",[147,162],{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":152,"contacts":153,"geoPoint":159},"MetroHealth Medical Center","Cleveland","Ohio","44106","United States",[154],{"name":155,"role":156,"phone":157,"email":158},"Kelly Gibson, MD","CONTACT","216-778-7076","kgibson@metrohealth.org",{"lat":160,"lon":161},41.4995,-81.69541,{"facility":163,"status":8,"city":149,"state":150,"zip":151,"country":152,"contacts":164,"geoPoint":169},"University Hospitals Rainbow Ahuja Women and Children's Center",[165],{"name":166,"role":156,"phone":167,"email":168},"Christopher Nau, MD","216-844-1000","Christopher.Nau@uhhospitals.org",{"lat":160,"lon":161},[171,175],{"name":172,"role":156,"phone":173,"email":174},"Samantha Bentley, MPH","216-368-1024","sxb1213@case.edu",{"name":176,"role":156,"phone":173,"email":177},"Elaine A Borawski, PhD","exb11@case.edu",[179],{"name":176,"affiliation":13,"role":180},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":184,"biomarkers":186},[185],"Pregnancy",[],{"nct_id":4,"found":15,"summary":188,"prompt_version":198},{"design":189,"status":190,"heading":191,"summary":192,"follow_up":193,"word_count":194,"commitments":195,"compensation":196,"drugs_mentioned":197},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 360 participants.","completed","Nourishing Tomorrow: Medically Tailored Groceries During Pregnancy","This study, \"Nourishing Tomorrow,\" is looking at how providing healthy, personalized groceries can help pregnant individuals who may not have enough food. We are comparing three ways to deliver these groceries: picking them up at a clinic (Clinic-Based Medically Tailored Groceries), having them delivered to your home (Home Delivered Medically Tailored Groceries), or home delivery with extra nutrition education (Home Delivered Medically Tailored Groceries plus Education). We want to see if these groceries can reduce food insecurity (not having reliable access to enough affordable, nutritious food) and improve birth outcomes like gestational age (how far along the pregnancy is at birth). We are looking for pregnant individuals between 18 and 55 years old, who are at least 10 weeks pregnant but less than 22 weeks, have a single baby, are English-speaking, live in Cuyahoga County, Ohio, and are eligible for Medicaid. The study aims to enroll 360 participants. The current status of the study is unclear.","Food insecurity will be measured up to 6 months post-delivery, and baby gestational age will be measured at birth.",156,"Patients have the opportunity to pick up medically tailored groceries every other week, or receive home delivered groceries every two weeks during pregnancy and up to 3 months post-delivery. Some participants will also receive additional nutrition and culinary education and support.","Not stated in the trial record.",[],null]