Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists (WEE)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early healthy lifestyles
Responsive parenting curriculum
Data sharing/coordination
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Responsive parenting
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
Sites / Locations
- Geisinger Health Systems
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Responsive parenting treatment
Standard Care Control
Arm Description
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.
Standard of pediatric and WIC care
Outcomes
Primary Outcome Measures
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
Infant rapid weight gain
Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths
Secondary Outcome Measures
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
Maternal knowledge/awareness of coordinated care
Assessed through Perceived Involvement in Care survey
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.
Full Information
NCT ID
NCT03482908
First Posted
March 23, 2018
Last Updated
March 12, 2019
Sponsor
Penn State University
Collaborators
Health Resources and Services Administration (HRSA), Geisinger Clinic, Pennsylvania Bureau of Women, Infants & Children (WIC)
1. Study Identification
Unique Protocol Identification Number
NCT03482908
Brief Title
Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists
Acronym
WEE
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
Health Resources and Services Administration (HRSA), Geisinger Clinic, Pennsylvania Bureau of Women, Infants & Children (WIC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Responsive parenting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Responsive parenting treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Standard of pediatric and WIC care
Intervention Type
Behavioral
Intervention Name(s)
Early healthy lifestyles
Other Intervention Name(s)
EHL
Intervention Description
Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future
Intervention Type
Behavioral
Intervention Name(s)
Responsive parenting curriculum
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Data sharing/coordination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infant Growth Measures
Description
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
Time Frame
At birth, and approximately at 2, 5 and 7 months after birth
Title
Infant rapid weight gain
Description
Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths
Time Frame
From birth to 6 months
Secondary Outcome Measure Information:
Title
Changes in attitudes, beliefs, knowledge, and parenting self-efficacy
Description
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
Time Frame
At approximately 2, 5 and 7 months postpartum
Title
Maternal knowledge/awareness of coordinated care
Description
Assessed through Perceived Involvement in Care survey
Time Frame
7 months postpartum
Title
Care coordination between WIC and Geisinger settings
Description
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.
Time Frame
At approximately 2, 5 and 7 months postpartum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer S Savage, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Bailey-Davis, DEd
Organizational Affiliation
Geisinger Health Systems
Official's Role
Study Director
Facility Information:
Facility Name
Geisinger Health Systems
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36367983
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. 2022 Nov 11. doi: 10.1089/chi.2022.0137. Online ahead of print.
Results Reference
derived
PubMed Identifier
33231559
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.
Results Reference
derived
PubMed Identifier
30180831
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.
Results Reference
derived
Learn more about this trial
Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists
We'll reach out to this number within 24 hrs