Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- Food Insecurity
研究概览
简要总结
This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB
详细描述
The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80).
The pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Medicaid eligible
- •Enrolls in the CHW Hub
- •Able to read and understand English
排除标准
- 未提供
研究组 & 干预措施
Financial Support and Navigation
$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.
干预措施: Financial Support (Other)
Food Delivery
Food box delivered to participant home every 2 weeks until 6 weeks post delivery
干预措施: Food Delivery (Behavioral)
Control Group
Selected from claims data, matched.
结局指标
主要结局
Food Insecurity
时间窗: Change from baseline to delivery
6 item, USDA measure; dichotomous outcome
Maternal depression
时间窗: Change from baseline to delivery
9 item, self-administered, assesses maternal depression
Neonatal Intensive Care (NICU) Utilization
时间窗: From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
number of days baby was admitted to NICU
Baby Gestational Age
时间窗: At delivery
Baby's gestational age at birth, measured in weeks
Days Hospitalization
时间窗: From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months
total number of days baby was hospitalized following birth
Social Support
时间窗: Change from baseline to delivery
6 item, self-administered, assesses emotional and instrumental social support
Mastery
时间窗: Change from baseline to delivery
7 item, self-administered, assesses skill development and control
Baby Birthweight
时间窗: At delivery
Baby's birthweight, measured in grams
Food Insecurity
时间窗: Change from baseline to 10 weeks post-randomization
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Maternal depression
时间窗: Change from baseline to 10 weeks post-randomization
9 item, self-administered, assesses maternal depression
Social Support
时间窗: Change from baseline to 10 weeks post-randomization
6 item, self-administered, assesses emotional and instrumental social support
Mastery
时间窗: Change from baseline to 10 weeks post-randomization
7 item, self-administered, assesses skill development and locus of control
次要结局
未报告次要终点
研究者
Elaine Borawski
Angela Bowen Williamson Professor of Community Nutrition
Case Western Reserve University