Obesity Clinical Trial
Official title:
Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes
The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims: Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed Aim 2: To determine the prevalence of and change in social needs Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
Status | Recruiting |
Enrollment | 250 |
Est. completion date | November 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ChristianaCare Women's Health patient - 18 years or older - 4 to 14 weeks pregnant - Singleton pregnancy - Medicaid - BMI of 30 or higher - Reside in New Castle County Exclusion Criteria: - Current diagnosis of type 1 or type 2 diabetes - Multiple pregnancy - Currently enrolled in another Community Health Worker program - Not able to store and prepare meals - Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization - Not able to understand and communicate effectively in English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | ChristianaCare Christiana Hospital | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
Christiana Care Health Services | University of Delaware |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social Determinants of Health | Measured with ChristianaCare Social Determinants of Health Screener; Number of socials needs range from 0-11, higher scores indicate greater number of social needs | Changes from baseline to 2-6 weeks after delivery | |
Primary | Gestational Weight Gain | Observed gestational weight gained | Changes from baseline to 2-6 weeks after delivery | |
Primary | Body Mass Index | Observed body mass index changes | Changes from baseline to 2-6 weeks after delivery | |
Primary | Gestational Diabetes | Occurrence of gestational diabetes | From baseline to delivery | |
Primary | Gestational Hypertension | Occurrence of gestational hypertension | From baseline to delivery | |
Primary | Systolic and Diastolic Blood Pressure | Observed systolic and diastolic blood pressure | Changes from baseline to 2-6 weeks after delivery | |
Primary | Preeclampsia | Occurrence of preeclampsia and week diagnosed during pregnancy | From baseline to 2-6 weeks after delivery | |
Primary | Hydramnios | Occurrence of hydramnios | From baseline to delivery | |
Primary | Gestational Age | Baby's gestational age at birth | At delivery | |
Primary | Small for Gestational Age | Birth weight less than 10th percentile based on gestational age | At delivery | |
Primary | Preterm Birth | Preterm birth less than 37 weeks | At delivery | |
Primary | Fetal Macrosomia | Birth weight greater than 90th percentile based on gestational age | At delivery | |
Primary | Cesarean Delivery | Occurrence of cesarean delivery including those planned and unplanned | At delivery | |
Primary | Fetal Death | Occurrence of fetal death | From baseline to delivery | |
Primary | NICU Admission | Occurrence of NICU admission for any reason | Within 48 hours after delivery | |
Primary | NICU Length of Stay | Number of days baby was admitted to NICU | From NICU admission date to NICU discharge date, assessed up to 90 days | |
Primary | Maternal Length of Stay | Number of days hospitalized following delivery | From delivery date to hospital discharge date, assessed up to 90 days | |
Primary | Postpartum Admission | Number of postpartum hospital admissions for any reason | From delivery discharge to 90 days after | |
Primary | Postpartum Admission Length of Stay | Number of days hospitalized | From postpartum admission date to hospital discharge date, assessed up to 90 days | |
Primary | Hospital Admission | Number of hospital admissions for any reason | From baseline up to delivery | |
Primary | Hospital Admission Length of Stay | Number of days hospitalized | From admission date to hospital discharge date, assessed up to 90 days | |
Primary | Emergency Room Visit | Number of emergency room visits for any reason | From baseline to 90 days after delivery | |
Secondary | Food Insecurity | Measured with United States Department of Agriculture Household Food Security Survey Module 6-Item Short Form, 30-day; Scores range from 0-6, higher scores indicate lower food security | Changes from baseline to 2-6 weeks after delivery | |
Secondary | Dietary Intake | Measured with Dietary Screener Questionnaire (DSQ-10) and six items from Dietary Screener Questionnaire (DSQ-26); Scores will be calculated using the National Cancer Institute's scoring algorithms | Changes from baseline to 2-6 weeks after delivery | |
Secondary | Health-Related Quality of Life | Measured with Centers for Disease Control and Prevention's Health-Related Quality of Life (HRQOL-4) scale; Number of healthy days range from 0-30, higher scores indicate greater number of healthy days | Changes from baseline to 2-6 weeks after delivery | |
Secondary | Cost-Related Medication Underuse | Measured with Cost-Related Medication Underuse; Scores range from 0-4, scores greater than 0 indicate cost-related medication underuse | Changes from baseline to 2-6 weeks after delivery |
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