Back to resultsSupporting Baby Behavior Through Pediatric Offices
Primary Purpose
Infant Behavior, Feeding Behavior, Breastfeeding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baby Behavior
Sponsored by
About this trial
This is an interventional prevention trial for Infant Behavior
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
Sites / Locations
- University of California, Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Baby Behavior
Control
Arm Description
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.
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 Outcome Measures
Weight-for-length growth trajectory
Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
Secondary Outcome Measures
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
Maternal depressive symptoms
Edinburgh Postnatal Depression Scale
Maternal self-efficacy
Perceived Maternal Parenting Self-Efficacy
Maternal perceived stress
Perceived Stress Scale Short-Form
Infant sleep patterns
Brief Infant Sleep Questionnaire
Infant development
Ages and Stages Questionnaire
Infant eating behavior
Baby Eating Behavior Questionnaire
Full Information
NCT ID
NCT02438878
First Posted
May 6, 2015
Last Updated
September 25, 2018
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02438878
Brief Title
Supporting Baby Behavior Through Pediatric Offices
Official Title
Supporting Baby Behavior Through Pediatric Offices
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 7, 2016 (Actual)
Study Completion Date
February 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Behavior, Feeding Behavior, Breastfeeding, Pediatric Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
423 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baby Behavior
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baby Behavior
Primary Outcome Measure Information:
Title
Weight-for-length growth trajectory
Description
Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
Time Frame
Up to 6 months postpartum
Secondary Outcome Measure Information:
Title
Infant feeding practices
Description
Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
Time Frame
1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
Title
Maternal depressive symptoms
Description
Edinburgh Postnatal Depression Scale
Time Frame
2 weeks and 6 months postpartum
Title
Maternal self-efficacy
Description
Perceived Maternal Parenting Self-Efficacy
Time Frame
1 week, 2 months, and 6 months postpartum
Title
Maternal perceived stress
Description
Perceived Stress Scale Short-Form
Time Frame
1 week, 2 months, and 6 months postpartum
Title
Infant sleep patterns
Description
Brief Infant Sleep Questionnaire
Time Frame
2 months and 6 months postpartum
Title
Infant development
Description
Ages and Stages Questionnaire
Time Frame
2 months, 4 months, and 6 months postpartum
Title
Infant eating behavior
Description
Baby Eating Behavior Questionnaire
Time Frame
4 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Heinig, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Supporting Baby Behavior Through Pediatric Offices
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