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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07494097

Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
380 (estimated)
Sponsor
Penn State University · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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. 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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALData integration around responsive parentingThe 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.
BEHAVIORALStandard Care (in control arm)Standard siloed care from PCPs and WIC nutritionists

Timeline

Start date
2026-08-01
Primary completion
2029-12-01
Completion
2029-12-01
First posted
2026-03-27
Last updated
2026-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07494097. Inclusion in this directory is not an endorsement.