Supporting Baby Behavior Through Pediatric Offices

NCT ID: NCT02438878

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-02-16

Brief Summary

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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

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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.

Conditions

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Infant Behavior Feeding Behavior Breastfeeding Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Baby Behavior

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Baby Behavior

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Heinig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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WIC NEI-12-TX

Identifier Type: OTHER

Identifier Source: secondary_id

687861

Identifier Type: -

Identifier Source: org_study_id

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