Supporting Baby Behavior Through Pediatric Offices

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Feeding Behavior; Infant Behavior; Breastfeeding
• Intervention / Treatment: Behavioral: Baby Behavior

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 Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Baby Behavior
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-for-length growth trajectory	Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards	Up to 6 months postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Jane Heinig, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 7, 2016
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 687861; WIC NEI-12-TX (Other Identifier: UC Davis)