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Clinical Trials/NCT02438878
NCT02438878CompletedNot Applicable

Supporting Baby Behavior Through Pediatric Offices

University of California, Davis1 site in 1 country423 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
423
Locations
1
Primary Endpoint
Weight-for-length growth trajectory

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Baby Behavior

Experimental

The intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition.

After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors.

Intervention: Baby Behavior (Behavioral)

Control

No Intervention

The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits.

Outcomes

Primary Outcomes

Weight-for-length growth trajectory

Time Frame: Up to 6 months postpartum

Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards

Secondary Outcomes

  • Maternal perceived stress(1 week, 2 months, and 6 months postpartum)
  • Infant feeding practices(1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum)
  • Infant eating behavior(4 months postpartum)
  • Maternal self-efficacy(1 week, 2 months, and 6 months postpartum)
  • Infant sleep patterns(2 months and 6 months postpartum)
  • Maternal depressive symptoms(2 weeks and 6 months postpartum)
  • Infant development(2 months, 4 months, and 6 months postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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