Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists (WEE)
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|ClinicalTrials.gov Identifier: NCT03482908|
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Early healthy lifestyles Behavioral: Responsive parenting curriculum Behavioral: Data sharing/coordination||Not Applicable|
This multi-site, randomized, controlled trial (RCT) will test the hypothesis that an individually tailored responsive parenting obesity prevention intervention that coordinates care provided by WIC nutritionists and primary care providers (PCPs) will be more effective than usual care at 1) delivering consistent messages and 2) changing maternal and infant behavior to 3) reduce/prevent rapid infant growth from birth to 6 months.
Geisinger research staff will recruit mother/infants dyads primarily from newborn nurseries from Geisinger Health Systems hospitals in Central Pennsylvania (PA). Mother-infant dydas may also be recruited directly from newborn well-child visits, prenatal WIC visits, and using social media platforms such as Facebook. Key eligibility criteria include that infants participate in the Special Supplemental Women, Infants and Children (WIC) program and receive clinical care from a participating Geisinger Health Systems pediatrician. Upon eligibility and receiving consent, mother/infant dyads will be randomized to 1 of 2 groups: intervention (coordination of care) or control (Geisinger standard of pediatric care), stratified on infant birth weight, race, and parity. In this study, coordination of care is defined at two levels: (1) PCPs and WIC will deliver the same, consistent messages and (2) providers will communicate with each other on preventive care plans regarding responsive parenting and nutrition education.
The intervention will consist of 3 components: 1) a parent self-assessment and screening survey called Early Healthy Living/Lifestyles (EHL) tool to assess the child's future obesity risk and tailor education; 2) parenting and nutrition education using the Healthy Active Living for Families curriculum (HALF) developed by the American Academy of Pediatrics, supplemented by evidence-based materials that teach mothers alternatives to using feeding to manage infant behavior, and establishing good sleep hygiene; and 3) coordination of care between PCPs and WIC nutritionists utilizing HIT. Components 1 and 2 focus on teaching mothers to recognize hunger and fullness signs in their infants, use alternative soothing strategies to feeding, develop good sleep hygiene routines, and engage in active social play.
Once consented and enrolled, all parents receive a welcome packet with brief parenting tips tailored to the group assignment. Intervention participants will also be mailed the responsive parenting curriculum after enrolling that addresses the domains of infant sleep, feeding, soothing and play. Pediatricians who have patients enrolled and randomized to the intervention group will have access to the EHL data in the patient's electronic health record which they then use to record notes about each well child visit. After each well-child visit, these notes including the EHL data will be electronically sent to the child's WIC nutritionist, to be read prior to a WIC nutrition appointment with that client.
Information from the WIC nutritionist appointments, including nutrition counseling codes from each appointment in addition to collected health information will then be sent to the child's pediatrician, to be included as part of the child's electronic health record.
Child's growth measures will be taken from the well baby visits, along with any unique information from the WIC nutritionist visits. In addition, data collection surveys will be distributed to all study participants at 2, 5 and 7 months after birth, either electronically or by paper packet.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||289 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A multi-site, randomized controlled trial (RCT) to test that hypothesis that an individually tailored responsive parenting obesity prevention intervention that coordinates care provided by WIC nutritionists and primary care providers will be effective to ultimately reduce/prevent obesity in infants.|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Coordination of Care Between Pediatricians and Women Infants & Children (WIC) Nutritionists: Early Obesity Prevention for WIC Mothers and Children|
|Actual Study Start Date :||July 6, 2016|
|Actual Primary Completion Date :||December 15, 2018|
|Actual Study Completion Date :||January 31, 2019|
Experimental: Responsive parenting treatment
Early Healthy Lifestyles (EHL) screening tool reported by participants to identify potentially obesogenic parenting practices and child behaviors; data sharing/coordination into electronic health records to inform counseling by trained providers; responsive parenting curriculum delivered by trained WIC nutritionists.
Behavioral: Early healthy lifestyles
Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future
Other Name: EHL
Behavioral: Responsive parenting curriculum
Information from the American Academy of Pediatrics Healthy Active Living for Families (HALF) program supplemented with messages from the INSIGHT study, that were written at the 5th grade reading level, with messages focused on 4 categories: 1) feeding the baby 2) soothing the baby 3) sleep health and 4) playing with the baby
Behavioral: Data sharing/coordination
Data integration into child's electronic health record that is shared between settings (WIC and GHS PCPs) with display and documentation features that informs counseling.
No Intervention: Standard Care Control
Standard of pediatric and WIC care
- Infant Growth Measures [ Time Frame: At birth, and approximately at 2, 5 and 7 months after birth ]Weight, length and age of child at each well-child visit, to calculate sex-specific weight-for-age z-scores and percent overweight based on World Health Organization (WHO) standards
- Infant rapid weight gain [ Time Frame: From birth to 6 months ]Change in sex-specific weight-for-age z-scores from birth to 6 months as described by LJ Griffiths
- Changes in attitudes, beliefs, knowledge, and parenting self-efficacy [ Time Frame: At approximately 2, 5 and 7 months postpartum ]Through behavioral surveys, the investigators will assess changes in attitudes, knowledge, and beliefs about parenting, and additionally parenting self-efficacy, and consistency of messages will also be assessed
- Maternal knowledge/awareness of coordinated care [ Time Frame: 7 months postpartum ]Assessed through Perceived Involvement in Care survey
- Care coordination between WIC and Geisinger settings [ Time Frame: At approximately 2, 5 and 7 months postpartum ]Care coordination between settings will be evaluated by monitoring the secure flow of participant-level data between Geisinger and WIC for data sharing, care coordination opportunities and documented care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482908
|United States, Pennsylvania|
|Geisinger Health Systems|
|Danville, Pennsylvania, United States, 17822|
|Principal Investigator:||Jennifer S Savage, PhD||Penn State University|
|Study Director:||Lisa Bailey-Davis, DEd||Geisinger Health Systems|