Clinical trial NCT02438878: Supporting Baby Behavior Through Pediatric Offices
Official title: Supporting Baby Behavior Through Pediatric Offices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Behavior
Feeding Behavior
Breastfeeding
Pediatric Obesity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 423
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.

Detailed description: The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants. The intervention, currently used in all California WIC agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying. This project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff. It is expected that trained staff will be prepared to share Baby Behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.

Eligibility criteria: Inclusion Criteria:

* Will attend a participating pediatric clinic for her well-baby visits
* Primiparous, singleton pregnancy
* Currently enrolled in WIC
* At least 18 years of age
* Speaks and reads English or Spanish
* Has a telephone and access to the internet
* Plans to stay in the area for 6 months after birth of infant
* Abstained from smoking during pregnancy

Exclusion criteria:

* Gave birth before 37 weeks gestation
* She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
* She and/or her infant has health condition(s) or known health risks that impact infant growth and development

Primary outcomes:
measure: Weight-for-length growth trajectory
timeFrame: Up to 6 months postpartum
Secondary outcomes:
measure: Infant feeding practices
timeFrame: 1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
measure: Maternal depressive symptoms
timeFrame: 2 weeks and 6 months postpartum
measure: Maternal self-efficacy
timeFrame: 1 week, 2 months, and 6 months postpartum
measure: Maternal perceived stress
timeFrame: 1 week, 2 months, and 6 months postpartum
measure: Infant sleep patterns
timeFrame: 2 months and 6 months postpartum
measure: Infant development
timeFrame: 2 months, 4 months, and 6 months postpartum
measure: Infant eating behavior
timeFrame: 4 months postpartum
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Jane Heinig, PhD
role: PRINCIPAL_INVESTIGATOR
References: