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NCT Number: NCT07494097

Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care (in control arm)

Behavioral

Standard siloed care from PCPs and WIC nutritionists

Primary outcomes

  1. Infant Weight Gain

    Time frame: From birth to age 6 months

    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.

  2. Child Body Mass Index

    Time frame: At child age 24 months (end of the study)

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

Secondary outcomes

  1. Parent Feeding Practices

    Time frame: From child age 2 to 6 months

    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.

  2. Parent Feeding Practices

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

    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.

  3. Parent Feeding Practices

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

    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.

  4. Child Diet Quality

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

    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.

Other outcomes

  1. Moderators of Intervention Effectiveness on Child BMI Z-scores

    Time frame: At child age 24 months (end of study)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amy M Moore, PhD, MS, RD

CONTACT

[email protected]

18148654954

Heather Kimble, MPS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: WEE Baby

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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