Clinical trial NCT03482908: Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists
Official title: Evaluating Coordination of Care Between Pediatricians and Women Infants & Children (WIC) Nutritionists: Early Obesity Prevention for WIC Mothers and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Responsive parenting
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Geisinger Clinic
name: Pennsylvania Bureau of Women, Infants & Children (WIC)
First posted: 2018-03-29
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A multi-site, randomized controlled trial (RCT) to test that hypothesis that an individually tailored responsive parenting obesity prevention intervention that coordinates care provided by WIC nutritionists and primary care providers will be effective to ultimately reduce/prevent obesity in infants.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Growth Measures
timeFrame: At birth, and approximately at 2, 5 and 7 months after birth
measure: Infant rapid weight gain
timeFrame: From birth to 6 months
Secondary outcomes:
measure: Changes in attitudes, beliefs, knowledge, and parenting self-efficacy
timeFrame: At approximately 2, 5 and 7 months postpartum
measure: Maternal knowledge/awareness of coordinated care
timeFrame: 7 months postpartum
measure: Care coordination between WIC and Geisinger settings
timeFrame: At approximately 2, 5 and 7 months postpartum
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health Systems
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Jennifer S Savage, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Health Systems
name: Lisa Bailey-Davis, DEd
role: STUDY_DIRECTOR
References:
citation: Savage JS, Moore AM, Kling SMR, Marini M, Hernandez E, Franceschelli Hosterman J, Hassink S, Paul IM, Bailey-Davis L. Coordination Between Primary Care and Women, Infants, and Children to Prevent Obesity for Infants from Low-Income Families: A Pragmatic Randomized Clinical Trial. Child Obes. 2023 Dec;19(8):515-524. doi: 10.1089/chi.2022.0137. Epub 2022 Nov 11.
citation: Kling SM, Harris HA, Marini M, Cook A, Hess LB, Lutcher S, Mowery J, Bell S, Hassink S, Hayward SB, Johnson G, Franceschelli Hosterman J, Paul IM, Seiler C, Sword S, Savage JS, Bailey-Davis L. Advanced Health Information Technologies to Engage Parents, Clinicians, and Community Nutritionists in Coordinating Responsive Parenting Care: Descriptive Case Series of the Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care Randomized Controlled Trial. JMIR Pediatr Parent. 2020 Nov 24;3(2):e22121. doi: 10.2196/22121.
citation: Savage JS, Kling SMR, Cook A, Hess L, Lutcher S, Marini M, Mowery J, Hayward S, Hassink S, Hosterman JF, Paul IM, Seiler C, Bailey-Davis L. A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol. BMC Pediatr. 2018 Sep 4;18(1):293. doi: 10.1186/s12887-018-1263-z.