Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Gestational Diabetes
研究概览
简要总结
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
详细描述
This study is a pilot randomized controlled trial where eligible pregnant ChristianaCare patients will be identified weekly through an automated list, and patients who consent will be randomized to 1 of 2 arms (Women's Health Delaware Food Farmacy vs. usual standard of care). Participants randomized to the Women's Health Delaware Food Farmacy program arm will receive medically tailored groceries that are high in micronutrients critical for a healthy pregnancy. The food provided will be the equivalent of 10 meals per person in the household per week and will be delivered to participants weekly from enrollment to 4 weeks after giving birth. Participants will receive culinary equipment and training, recipes, and educational nutrition videos and will interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals. Participants randomized to the usual standard of care arm will continue to receive their standard of care management.
All participants will complete a questionnaire with patient-reported outcomes (i.e., food insecurity, dietary intake, health-related quality of life, and cost-related medication underuse) at baseline and postpartum and a patient experience survey postpartum related to their experiences receiving prenatal care and giving birth at ChristianaCare. In addition, maternal and child health, healthcare utilization, and clinical event outcomes will be documented for all participants via electronic health records and assessed retrospectively. Quantitative indicators related to feasibility (i.e., acceptability, demand, and implementation) will be collected such as program satisfaction, program enrollment and retention, meals provided to participants and their household, food consumption, and interactions with assigned Community Health Worker.
Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed
H1. Primary outcomes. The investigators hypothesize that the Women's Health Delaware Food Farmacy will: (a) prove acceptable to participants, as measured by program satisfaction; (b) meet demand, as measured by project recruitment and retention, number of meals provided to participants and their household, and number of people providing food for; and (c) prove implementable, as measured by food consumption, number of Community Health Worker interactions, number of educational videos watched, number of recipes reviewed, and number of meal preparation sessions.
Aim 2: To determine the prevalence of and change in social needs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ChristianaCare Women's Health patient
- •18 years or older
- •4 to 14 weeks pregnant
- •Singleton pregnancy
- •BMI of 30 or higher
- •Reside in New Castle County
排除标准
- •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
研究组 & 干预措施
Usual Standard of Care
Participants will receive the usual standard of care.
干预措施: Usual Standard of Care (Other)
Women's Health Delaware Food Farmacy
Participants will receive medically tailored groceries (10 meals per person in the household per week from enrollment to 4 weeks after delivery) high in micronutrients that are delivered to their homes weekly. They will also interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals.
干预措施: Women's Health Delaware Food Farmacy (Other)
结局指标
主要结局
Gestational Diabetes
时间窗: From baseline to delivery
Occurrence of gestational diabetes
Cesarean Delivery
时间窗: At delivery
Occurrence of cesarean delivery including those planned and unplanned
Fetal Death
时间窗: From baseline to delivery
Occurrence of fetal death
Preterm Birth
时间窗: At delivery
Preterm birth less than 37 weeks
Social Determinants of Health
时间窗: Changes from baseline to 2-6 weeks after delivery
Measured with ChristianaCare Social Determinants of Health Screener; Number of socials needs range from 0-11, higher scores indicate greater number of social needs
Gestational Weight Gain
时间窗: Changes from baseline to 2-6 weeks after delivery
Observed gestational weight gained
Preeclampsia
时间窗: From baseline to 2-6 weeks after delivery
Occurrence of preeclampsia and week diagnosed during pregnancy
Gestational Age
时间窗: At delivery
Baby's gestational age at birth
Gestational Hypertension
时间窗: From baseline to delivery
Occurrence of gestational hypertension
Systolic and Diastolic Blood Pressure
时间窗: Changes from baseline to 2-6 weeks after delivery
Observed systolic and diastolic blood pressure
Small for Gestational Age
时间窗: At delivery
Birth weight less than 10th percentile based on gestational age
Fetal Macrosomia
时间窗: At delivery
Birth weight greater than 90th percentile based on gestational age
Hospital Admission Length of Stay
时间窗: From admission date to hospital discharge date, assessed up to 90 days
Number of days hospitalized
NICU Length of Stay
时间窗: From NICU admission date to NICU discharge date, assessed up to 90 days
Number of days baby was admitted to NICU
Hospital Admission
时间窗: From baseline up to delivery
Number of hospital admissions for any reason
Emergency Room Visit
时间窗: From baseline to 90 days after delivery
Number of emergency room visits for any reason
Body Mass Index
时间窗: Changes from baseline to 2-6 weeks after delivery
Observed body mass index changes
Hydramnios
时间窗: From baseline to delivery
Occurrence of hydramnios
NICU Admission
时间窗: Within 48 hours after delivery
Occurrence of NICU admission for any reason
Maternal Length of Stay
时间窗: From delivery date to hospital discharge date, assessed up to 90 days
Number of days hospitalized following delivery
Postpartum Admission Length of Stay
时间窗: From postpartum admission date to hospital discharge date, assessed up to 90 days
Number of days hospitalized
Postpartum Admission
时间窗: From delivery discharge to 90 days after
Number of postpartum hospital admissions for any reason
次要结局
- Dietary Intake(Changes from baseline to 2-6 weeks after delivery)
- Food Insecurity(Changes from baseline to 2-6 weeks after delivery)
- Health-Related Quality of Life(Changes from baseline to 2-6 weeks after delivery)
- Cost-Related Medication Underuse(Changes from baseline to 2-6 weeks after delivery)
