Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists (WEE Baby)

Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists for Early Obesity Prevention Among WIC Mothers and Children

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. 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. 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?

The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.

Study Overview

• Status: Not yet recruiting
• Conditions: BMI; Diet Quality; Implementation; Responsive Parenting; Weight Gain Trajectory
• Intervention / Treatment: Behavioral: Data integration around responsive parenting; Behavioral: Standard Care (in control arm)

Detailed Description

The first two years of a child's life lay the foundation for developing healthy eating, sleep, activity, and emotion regulation habits. These habits can help lower the risk of obesity later in childhood. However, young children in low-income rural communities are more likely to experience poverty and have limited access to nutritious and affordable foods, contributing to a higher risk of obesity and cardiometabolic diseases. To reduce health disparities among young children living in rural low-income communities, there is a critical need for effective and scalable evidence-based interventions to support parents of young children starting early in life. Leveraging existing settings such as health care (standard well-child visits) and social care (Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) visits) for evidence-based intervention delivery is an effective way to reach the parents of young children living in low-income contexts, who have multiple visits with providers in these settings across the first 24 months of life. A series of reports from professional organizations have called for solution-oriented approaches, moving away from siloed health care (primary care providers (PCPs)) and social care (WIC nutritionists) towards integrated care between these settings using health information technologies (secure digital systems to share information) to enhance obesity prevention efforts and reduce health disparities. The goal of this research is to leverage existing care settings and use health information technologies to digitally integrate care and deliver an evidence-based, responsive parenting intervention to mother-infant dyads living in rural, low-income communities that experience health disparities. This research will include a two-arm randomized controlled trial to test the effectiveness of an integrated, patient-centered responsive parenting intervention on rapid infant weight gain and child BMI z-score at age 24 months (Aim 1), the effectiveness of the intervention on responsive parenting practices and child diet quality (Aim 2), an evaluation of whether the intervention is more or less effective in certain groups (Aim 3), and an evaluation of factors influencing effective implementation across health care, social care, and home settings (Aim 4). The investigators hypothesize that compared to standard care (siloed PCP and WIC nutritionist care), children in the integrated PCP-WIC nutritionist care will gain weight less rapidly from birth to 6 months and have a lower BMI z-score at age 24 months. Integrating care between trusted providers creates an opportunity to increase the time spent discussing child health in these often time-constrained settings, deliver consistent, integrated care on responsive parenting, and inform scalable efforts to promote healthy child growth from the start and reduce health disparities among children living in rural, low-income communities.

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy M Moore, PhD, MS, RD; Phone Number: 18148654954; Email: amm9107@psu.edu
• Study Contact Backup: Name: Heather Kimble, MPS; Email: hmo106@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• People who are a) pregnant and >34 weeks' gestation or b) who have an infant <2 months old
• 18-40 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated PCP-WIC Nutritionist Care; Integrated care between PCPs and WIC nutritionists using health information technologies to promote responsive parenting and healthy growth	Behavioral: Data integration around responsive parenting; 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.
Active Comparator: Standard Care; 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); Standard siloed care from PCPs and WIC nutritionists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Feeding Practices	Differences in parent feeding practice scores between intervention and control conditions will be measured using the 12-item Baby's Basic Needs Questionnaire, which assesses context-based (e.g., before bed) and emotion-based (e.g., food to soothe) feeding during infancy. Items are scored on a 5-point scale with responses from Never (1) to Always (5). Items are averaged to create a score for each subscale, and all items are averaged to create a total score, with higher scores indicating greater use of context-based, emotion-based, and total food to soothe.	From child age 2 to 6 months
Parent Feeding Practices	Differences in parent feeding practice scores between intervention and control conditions will be measured using the Structure and Control in Parent Feeding questionnaire, which assesses responsive, structure-based feeding practices (i.e., limit-setting, consistent routines) and non-responsive, control-based feeding practices (i.e., restriction, pressure to eat) during toddlerhood. Items are scored on a 5-point Likert scale (0 = never to 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.	From child age 9 to 24 months (end of study)
Parent Feeding Practices	Differences in parent feeding practice scores between intervention and control conditions will be assessed using the Feeding to Manage Child Behavior questionnaire, a 9-item measure that assesses parents' use of food to soothe and food as reward. Items are scored on a 5-point Likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in food to soothe or as a reward.	From child age 9 to 24 months (end of study)
Child Diet Quality	Differences in child diet quality scores between the intervention and control conditions will be measured using the Mediterranean Eating Pattern for Americans-Child version. This is a 6-item parent-report measure of a child's diet quality, tailored to the child's developmental age, that captures recommended foods (e.g., fruits, vegetables, human milk) and non-recommended foods (e.g., sweets, SSBs, fast foods). The total score could range from 0 to 6. Scores will be converted to points on a 100-point scale using the 6-item measure's quantiles. For example, scores of 0 (0 points), 3 (55 points), and 6 (100 points), with higher scores meaning better diet quality.	From child age 2 to 24 months (end of study)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderators of Intervention Effectiveness on Child BMI Z-scores	Moderators of intervention effectiveness on child BMI z-scores will include child characteristics (e.g., sex, temperament, appetitive traits), maternal psychosocial factors (e.g., perceived stress, social support), and social determinants of health (e.g., income, food and nutrition security, access to reliable transportation).	At child age 24 months (end of study)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Responsive Parenting; Child Weight; Health Information Technologies
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body-Weight Trajectory; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 1R01MD020718-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No