Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 3
- 主要终点
- Change in Postpartum Weight Retention
研究概览
简要总结
This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on postpartum mothers and infants. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.
详细描述
This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on pregnant and postpartum mothers. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.
A second goal of the hybrid study is to understand the reach, engagement, and context for implementation of Family Check-Up Heart and gather information for development of the multi-center home visiting model trial. The Family Check-Up Heart program is intended to improve the cardiovascular health of low-income mothers compared to the traditional Family Check-Up and other home visiting programs by incorporating individualized, culturally competent interventions that target diet and exercise, blood pressure control, stress management and self-care, and smoking cessation. The intervention includes cardiovascular assessment and feedback, followed by a tailored treatment program delivered by family coaches in 3-4 week modules to establish goals and track progress. These sessions will work towards obtaining positive cardiovascular health outcomes and empowering mothers of infants to achieve their goals through education and a connection to resources which the investigators hypothesize will also preserve child cardiovascular health. Primary analyses will assess the impact of Family Check-Up Heart on maternal cardiovascular health outcomes when the child is 6 months old compared to Family Check-Up alone.
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
- Single (Investigator)
盲法说明
Investigators will be blind to group assignment during intervention delivery and assessment.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inclusion criteria:
- •Pregnant women/birthing people or women/birthing people who have delivered in the past 2 months who deliver at Magee or are enrolled in the Women Infants and Children program in Allegheny County.
- •Medicaid-eligible
- •Speak English.
- •Resident of Allegheny County, Pennsylvania.
- •Does not have complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
- •Participants who consent to enrollment may have their medical history reviewed by study physicians and staff to adjudicate pregnancy outcomes and ensure they meet inclusion criteria before randomization.
- •Child inclusion criteria:
- •Children birth through 2 months who reside in Allegheny County may enroll in the program if their mother is participating in the study.
- •Has a legal guardian who speaks English. This criterion is included because the project's materials and assessments are currently only available in English, with staff only fluent in English.
排除标准
- •Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
- •Multifetal pregnancies or deliveries.
研究组 & 干预措施
Family Check Up Control
The Family Check-Up is a home visiting program that typically takes place over the course of 3-5 sessions - An initial interview, assessment, feedback session, and optional treatment sessions. The Family Check-Up is designed to support child development and improve parental well-being.
干预措施: Family Check-Up (Behavioral)
Family Check-Up Heart
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
干预措施: Family Check Up Heart (Behavioral)
结局指标
主要结局
Change in Postpartum Weight Retention
时间窗: Baseline to 6 months post-partum
Weight change from post-delivery to 6 months; both will be measured by the study using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.
次要结局
- Weight at 6 Months Postpartum(6 months post-partum)
- Weight Change From First Measured Prenatal Weight to 6 Months Postpartum(Baseline to 6 months post-partum)
- Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum(Baseline to 6 months post-partum)
- Change in Eating Behaviors(Baseline to 6 months post-partum)
- Change in Blood Pressure From Post-delivery to 6 Months.(Baseline to 6 months post-partum)
- Change in Blood Pressure From First Prenatal Visit to 6 Months.(Baseline to 6 months post-partum)
- Blood Pressure at 6 Months Post-partum(6 months post-partum)
- BMI at 6 Months Post-partum(6 months post-partum)
- Change in Physical Activity(Baseline to 6 months post-partum)
研究者
Janet Catov
Associate Professor
University of Pittsburgh