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临床试验/NCT06180811
NCT06180811招募中不适用

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月2日最近更新:
适应症
干预措施

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

Active Comparator

Participants will receive the usual standard of care.

干预措施: Usual Standard of Care (Other)

Women's Health Delaware Food Farmacy

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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