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:
- 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?
- 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
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
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
|
Standard siloed care from PCPs and WIC nutritionists
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From birth to age 6 months
|
|
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.
|
At child age 24 months (end of the study)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From child age 2 to 6 months
|
|
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.
|
From child age 9 to 24 months (end of study)
|
|
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.
|
From child age 9 to 24 months (end of study)
|
|
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.
|
From child age 2 to 24 months (end of study)
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At child age 24 months (end of study)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
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
Studies a U.S. FDA-regulated device product
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