NCT02438878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2017

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

May 6, 2015

Last Update Submit

September 25, 2018

Conditions

Infant BehaviorFeeding BehaviorBreastfeedingPediatric Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight-for-length growth trajectory

    Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards

    Up to 6 months postpartum

Secondary Outcomes (7)

  • Infant feeding practices

    1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum

  • Maternal depressive symptoms

    2 weeks and 6 months postpartum

  • Maternal self-efficacy

    1 week, 2 months, and 6 months postpartum

  • Maternal perceived stress

    1 week, 2 months, and 6 months postpartum

  • Infant sleep patterns

    2 months and 6 months postpartum

  • +2 more secondary outcomes

Study Arms (2)

Baby Behavior

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Baby BehaviorBEHAVIORAL
Baby Behavior

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Infant BehaviorFeeding BehaviorBreast FeedingPediatric Obesity

Condition Hierarchy (Ancestors)

Child BehaviorBehaviorBehavior, AnimalObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jane Heinig, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

March 1, 2015

Primary Completion

December 7, 2016

Study Completion

February 16, 2017

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

US(1)