Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

NCT07494097 | Not Yet Recruiting

• 1 other identifier: 1R01MD020718-01
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are:

1. 1.Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting to support healthy growth from birth to 24 months?
2. 2.Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting, improve responsive parenting practices and child diet quality?

Conditions

Weight Gain Trajectory; BMI; Responsive Parenting; Diet Quality; Implementation

Keywords

Child Weight; Responsive Parenting; Health Information Technologies

Outcome Measures

Primary Outcomes (2)

• Infant Weight Gain

  Change in weight-for-age z-score (WAZ) from birth to 6 months, with positive conditional weight gain scores indicating rapid or faster than average infant weight gain and negative scores indicating slower than average infant weight gain.

  From birth to age 6 months

• Child Body Mass Index

  Body mass index z-scores at child age 24 months, calculated using WHO Child Growth Standards.

  At child age 24 months (end of the study)

Secondary Outcomes (4)

• Parent Feeding Practices

  From child age 2 to 6 months

• Parent Feeding Practices

  From child age 9 to 24 months (end of study)

• Parent Feeding Practices

  From child age 9 to 24 months (end of study)

• Child Diet Quality

  From child age 2 to 24 months (end of study)

Other Outcomes (1)

• Moderators of Intervention Effectiveness on Child BMI Z-scores

  At child age 24 months (end of study)

Study Arms (2)

Integrated PCP-WIC Nutritionist Care

EXPERIMENTAL

Integrated care between PCPs and WIC nutritionists using health information technologies to promote responsive parenting and healthy growth

Behavioral: Data integration around responsive parenting

Standard Care

ACTIVE COMPARATOR

Standard siloed care from PCPs and WIC nutritionists without using health information technologies to promote responsive parenting and healthy growth

Behavioral: Standard Care (in control arm)

Interventions

Data integration around responsive parenting BEHAVIORAL

The integrated PCP-WIC nutritionist care intervention group will receive 1) behavioral risk screening using a patient-reported outcome measure that is completed in the child's electronic health record; 2) an evidence-based responsive parenting curriculum ; 3) electronic integration and coordination between care settings to document and inform patient-centered messaging; and 4) telehealth coaching sessions and online educational modules to reinforce responsive parenting messaging at home.

Integrated PCP-WIC Nutritionist Care

Standard Care (in control arm) BEHAVIORAL

Standard siloed care from PCPs and WIC nutritionists

Standard Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• People who are a) pregnant and \>34 weeks' gestation or b) who have an infant \<2 months old
• years old
• English and/or Spanish speaking and reading
• Access to a smartphone or internet-connected device
• Not planning to move out of Pennsylvania within 2 years
• Not planning to change health care providers outside of Geisinger within 2 years
• Custody of and lives with (or will live with) the child enrolled in the study
• Child must have a Geisinger PCP and be a WIC participant or eligible for WIC at enrollment

You may not qualify if:

• Mother is not interested (or willing) to enroll in WIC
• Child has a genetic or developmental disorder (e.g., cleft palate) that impacts weight or feeding
• Child has a terminal condition

Sponsors & Collaborators

• Penn State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Body-Weight Trajectory

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Amy M Moore, PhD, MS, RD

CONTACT

18148654954; amm9107@psu.edu

Heather Kimble, MPS

CONTACT

hmo106@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)