NCT03482908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

March 23, 2018

Last Update Submit

March 12, 2019

Conditions

Childhood Obesity

Keywords

Responsive parenting

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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.

Behavioral: Early healthy lifestylesBehavioral: Responsive parenting curriculumBehavioral: Data sharing/coordination

Standard Care Control

NO INTERVENTION

Standard of pediatric and WIC care

Interventions

Early healthy lifestylesBEHAVIORAL

Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future

Also known as: EHL
Responsive parenting treatment
Responsive parenting curriculumBEHAVIORAL

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

Responsive parenting treatment
Data sharing/coordinationBEHAVIORAL

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.

Responsive parenting treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health Systems

Danville, Pennsylvania, 17822, United States

Location

Related Publications (3)

  • 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.

    PMID: 36367983DERIVED

  • 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.

    PMID: 33231559DERIVED

  • 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.

    PMID: 30180831DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer S Savage, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Lisa Bailey-Davis, DEd

    Geisinger Health Systems

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nutritional Sciences

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 29, 2018

Study Start

July 6, 2016

Primary Completion

December 15, 2018

Study Completion

January 31, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)