跳至主要内容
临床试验/NCT03482908
NCT03482908已完成不适用

Evaluating Coordination of Care Between Pediatricians and Women Infants & Children (WIC) Nutritionists: Early Obesity Prevention for WIC Mothers and Children

Penn State University2 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2016年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
289
试验地点
2
主要终点
Infant Growth Measures

研究概览

简要总结

WEE Baby Care is a 6 month intervention that coordinates care across multiple settings- health care clinics and WIC clinics on responsive parenting practices to increase parenting competence thereby preventing infant rapid weight gain. The investigators will recruit mother/infant dyads in Central PA, who participate in the Women, Infants, and Children (WIC) program and receive clinical care from a Geisinger pediatrician participating in this study.

详细描述

This multi-site, randomized, controlled trial (RCT) will test the hypothesis that an individually tailored responsive parenting obesity prevention intervention that coordinates care provided by WIC nutritionists and primary care providers (PCPs) will be more effective than usual care at 1) delivering consistent messages and 2) changing maternal and infant behavior to 3) reduce/prevent rapid infant growth from birth to 6 months.

Geisinger research staff will recruit mother/infants dyads primarily from newborn nurseries from Geisinger Health Systems hospitals in Central Pennsylvania (PA). Mother-infant dydas may also be recruited directly from newborn well-child visits, prenatal WIC visits, and using social media platforms such as Facebook. Key eligibility criteria include that infants participate in the Special Supplemental Women, Infants and Children (WIC) program and receive clinical care from a participating Geisinger Health Systems pediatrician. Upon eligibility and receiving consent, mother/infant dyads will be randomized to 1 of 2 groups: intervention (coordination of care) or control (Geisinger standard of pediatric care), stratified on infant birth weight, race, and parity. In this study, coordination of care is defined at two levels: (1) PCPs and WIC will deliver the same, consistent messages and (2) providers will communicate with each other on preventive care plans regarding responsive parenting and nutrition education.

The intervention will consist of 3 components: 1) a parent self-assessment and screening survey called Early Healthy Living/Lifestyles (EHL) tool to assess the child's future obesity risk and tailor education; 2) parenting and nutrition education using the Healthy Active Living for Families curriculum (HALF) developed by the American Academy of Pediatrics, supplemented by evidence-based materials that teach mothers alternatives to using feeding to manage infant behavior, and establishing good sleep hygiene; and 3) coordination of care between PCPs and WIC nutritionists utilizing HIT. Components 1 and 2 focus on teaching mothers to recognize hunger and fullness signs in their infants, use alternative soothing strategies to feeding, develop good sleep hygiene routines, and engage in active social play.

Once consented and enrolled, all parents receive a welcome packet with brief parenting tips tailored to the group assignment. Intervention participants will also be mailed the responsive parenting curriculum after enrolling that addresses the domains of infant sleep, feeding, soothing and play. Pediatricians who have patients enrolled and randomized to the intervention group will have access to the EHL data in the patient's electronic health record which they then use to record notes about each well child visit. After each well-child visit, these notes including the EHL data will be electronically sent to the child's WIC nutritionist, to be read prior to a WIC nutrition appointment with that client.

Information from the WIC nutritionist appointments, including nutrition counseling codes from each appointment in addition to collected health information will then be sent to the child's pediatrician, to be included as part of the child's electronic health record.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mother is English speaking, infant is a singleton birth, infant birthweight greater than or equal to 2500g, infant gestational age at least 37 weeks, infant no more than 2 months old, no plans for baby to be put up for adoption, no congenital or neonatal conditions that would affect growth, mother has no major morbidities that would affect postpartum care, eligible and/or enrolled in a WIC program in central PA, infant pediatrician is a Geisinger physician in a pediatric service line in Luzerne county

排除标准

  • non-English speaking, mother is planning to leave the county where she enrolled within 6-9 months, mother is less than 18 years of age, mother is older than 55 years of age

研究组 & 干预措施

Responsive parenting treatment

Experimental

Early Healthy Lifestyles (EHL) screening tool reported by participants to identify potentially obesogenic parenting practices and child behaviors; data sharing/coordination into electronic health records to inform counseling by trained providers; responsive parenting curriculum delivered by trained WIC nutritionists.

干预措施: Early healthy lifestyles (Behavioral)

Responsive parenting treatment

Experimental

Early Healthy Lifestyles (EHL) screening tool reported by participants to identify potentially obesogenic parenting practices and child behaviors; data sharing/coordination into electronic health records to inform counseling by trained providers; responsive parenting curriculum delivered by trained WIC nutritionists.

干预措施: Responsive parenting curriculum (Behavioral)

Responsive parenting treatment

Experimental

Early Healthy Lifestyles (EHL) screening tool reported by participants to identify potentially obesogenic parenting practices and child behaviors; data sharing/coordination into electronic health records to inform counseling by trained providers; responsive parenting curriculum delivered by trained WIC nutritionists.

干预措施: Data sharing/coordination (Behavioral)

Standard Care Control

No Intervention

Standard of pediatric and WIC care

结局指标

主要结局

Infant Growth Measures

时间窗: At birth, and approximately at 2, 5 and 7 months after birth

Weight, length and age of child at each well-child visit, to calculate sex-specific weight-for-age z-scores and percent overweight based on World Health Organization (WHO) standards

Infant rapid weight gain

时间窗: From birth to 6 months

Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths

次要结局

  • Changes in attitudes, beliefs, knowledge, and parenting self-efficacy(At approximately 2, 5 and 7 months postpartum)
  • Maternal knowledge/awareness of coordinated care(7 months postpartum)
  • Care coordination between WIC and Geisinger settings(At approximately 2, 5 and 7 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Savage Williams

Assistant Professor of Nutritional Sciences

Penn State University

研究点 (2)

Loading locations...

相似试验