Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Integrated PCP-WIC Nutritionist CareExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From birth to age 6 months
2

Child Body Mass Index

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

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

Secondary outcomes

1

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.

Time frame
From child age 2 to 6 months
2

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.

Time frame
From child age 9 to 24 months (end of study)
3

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.

Time frame
From child age 9 to 24 months (end of study)
4

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.

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

Other outcomes

1

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).

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

Sponsors and contacts

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Penn State University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

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