Supporting Baby Behavior Through Pediatric Offices

Not Applicable

Completed

• Conditions: Infant Behavior; Breastfeeding; Pediatric Obesity; Feeding Behavior
• Interventions: Behavioral: Baby Behavior

• Registration Number: NCT02438878
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Primary Completion: 2016-12-07
• Study Completion: 2017-02-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 423

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baby Behavior	Baby Behavior	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.

Primary Outcome Measures

Name	Time	Method
Weight-for-length growth trajectory	Up to 6 months postpartum	Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards

Secondary Outcome Measures

Name	Time	Method
Maternal perceived stress	1 week, 2 months, and 6 months postpartum	Perceived Stress Scale Short-Form
Infant feeding practices	1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum	Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
Infant eating behavior	4 months postpartum	Baby Eating Behavior Questionnaire
Maternal self-efficacy	1 week, 2 months, and 6 months postpartum	Perceived Maternal Parenting Self-Efficacy
Infant sleep patterns	2 months and 6 months postpartum	Brief Infant Sleep Questionnaire
Maternal depressive symptoms	2 weeks and 6 months postpartum	Edinburgh Postnatal Depression Scale
Infant development	2 months, 4 months, and 6 months postpartum	Ages and Stages Questionnaire

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States