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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Data integration around responsive parenting
BehavioralThe 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)
BehavioralStandard siloed care from PCPs and WIC nutritionists
Treatment groups
Trial outcomes
Primary outcomes
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.
Child Body Mass Index
Body mass index z-scores at child age 24 months, calculated using WHO Child Growth Standards.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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).
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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