Supporting Baby Behavior Through Pediatric Offices

Breastfeeding Clinical Trial

Official title:

Supporting Baby Behavior Through Pediatric Offices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438878
• Other study ID #: 687861
• Secondary ID: WIC NEI-12-TX
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 16, 2017

Study information

• Verified date: September 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: February 16, 2017
• Est. primary completion date: December 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Feeding Behavior
• Infant Behavior
• Pediatric Obesity

Intervention

Behavioral:
• Baby Behavior

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-for-length growth trajectory	Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards	Up to 6 months postpartum
Secondary	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
Secondary	Maternal depressive symptoms	Edinburgh Postnatal Depression Scale	2 weeks and 6 months postpartum
Secondary	Maternal self-efficacy	Perceived Maternal Parenting Self-Efficacy	1 week, 2 months, and 6 months postpartum
Secondary	Maternal perceived stress	Perceived Stress Scale Short-Form	1 week, 2 months, and 6 months postpartum
Secondary	Infant sleep patterns	Brief Infant Sleep Questionnaire	2 months and 6 months postpartum
Secondary	Infant development	Ages and Stages Questionnaire	2 months, 4 months, and 6 months postpartum
Secondary	Infant eating behavior	Baby Eating Behavior Questionnaire	4 months postpartum