Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists

Childhood Obesity Clinical Trial

— WEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482908
• Other study ID #: 1 R40MC283170100
• Status: Completed
• Phase: N/A
• Start date: July 6, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: January 31, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Early healthy lifestyles
Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future
• Responsive parenting curriculum
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 sharing/coordination
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.

Locations

Country	Name	City	State
United States	Geisinger Health Systems	Danville	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	Geisinger Clinic, Health Resources and Services Administration (HRSA), Pennsylvania Bureau of Women, Infants & Children (WIC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Growth Measures	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
Primary	Infant rapid weight gain	Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths	From birth to 6 months
Secondary	Changes in attitudes, beliefs, knowledge, and parenting self-efficacy	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
Secondary	Maternal knowledge/awareness of coordinated care	Assessed through Perceived Involvement in Care survey	7 months postpartum
Secondary	Care coordination between WIC and Geisinger settings	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