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Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists (WEE)

12 de marzo de 2019 actualizado por: Jennifer Savage Williams, Penn State University

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

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.

Descripción general del estudio

Descripción detallada

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.

Child's growth measures will be taken from the well baby visits, along with any unique information from the WIC nutritionist visits. In addition, data collection surveys will be distributed to all study participants at 2, 5 and 7 months after birth, either electronically or by paper packet.

Tipo de estudio

Intervencionista

Inscripción (Actual)

289

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Geisinger Health Systems

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Responsive parenting treatment
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.
Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future
Otros nombres:
  • EHL
Information from the American Academy of Pediatrics Healthy Active Living for Families (HALF) program supplemented with messages from the INSIGHT study, that were written at the 5th grade reading level, with messages focused on 4 categories: 1) feeding the baby 2) soothing the baby 3) sleep health and 4) playing with the baby
Data integration into child's electronic health record that is shared between settings (WIC and GHS PCPs) with display and documentation features that informs counseling.
Sin intervención: Standard Care Control
Standard of pediatric and WIC care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Infant Growth Measures
Periodo de tiempo: 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
At birth, and approximately at 2, 5 and 7 months after birth
Infant rapid weight gain
Periodo de tiempo: From birth to 6 months
Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths
From birth to 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in attitudes, beliefs, knowledge, and parenting self-efficacy
Periodo de tiempo: At approximately 2, 5 and 7 months postpartum
Through behavioral surveys, the investigators will assess changes in attitudes, knowledge, and beliefs about parenting, and additionally parenting self-efficacy, and consistency of messages will also be assessed
At approximately 2, 5 and 7 months postpartum
Maternal knowledge/awareness of coordinated care
Periodo de tiempo: 7 months postpartum
Assessed through Perceived Involvement in Care survey
7 months postpartum
Care coordination between WIC and Geisinger settings
Periodo de tiempo: At approximately 2, 5 and 7 months postpartum
Care coordination between settings will be evaluated by monitoring the secure flow of participant-level data between Geisinger and WIC for data sharing, care coordination opportunities and documented care.
At approximately 2, 5 and 7 months postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jennifer S Savage, PhD, Penn State University
  • Director de estudio: Lisa Bailey-Davis, DEd, Geisinger Health Systems

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de julio de 2016

Finalización primaria (Actual)

15 de diciembre de 2018

Finalización del estudio (Actual)

31 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

23 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

23 de marzo de 2018

Publicado por primera vez (Actual)

29 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de marzo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 1 R40MC283170100

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Early healthy lifestyles

3
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