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Supporting Baby Behavior Through Pediatric Offices

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ClinicalTrials.gov Identifier: NCT02438878
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Infant Behavior Feeding Behavior Breastfeeding Pediatric Obesity Behavioral: Baby Behavior Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Supporting Baby Behavior Through Pediatric Offices
Actual Study Start Date : March 2015
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

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.



Primary Outcome Measures :
  1. Weight-for-length growth trajectory [ Time Frame: Up to 6 months postpartum ]
    Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards


Secondary Outcome Measures :
  1. Infant feeding practices [ Time Frame: 1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum ]
    Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods

  2. Maternal depressive symptoms [ Time Frame: 2 weeks and 6 months postpartum ]
    Edinburgh Postnatal Depression Scale

  3. Maternal self-efficacy [ Time Frame: 1 week, 2 months, and 6 months postpartum ]
    Perceived Maternal Parenting Self-Efficacy

  4. Maternal perceived stress [ Time Frame: 1 week, 2 months, and 6 months postpartum ]
    Perceived Stress Scale Short-Form

  5. Infant sleep patterns [ Time Frame: 2 months and 6 months postpartum ]
    Brief Infant Sleep Questionnaire

  6. Infant development [ Time Frame: 2 months, 4 months, and 6 months postpartum ]
    Ages and Stages Questionnaire

  7. Infant eating behavior [ Time Frame: 4 months postpartum ]
    Baby Eating Behavior Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438878


Locations
United States, California
University of California, Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Jane Heinig, PhD University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02438878     History of Changes
Other Study ID Numbers: 687861
WIC NEI-12-TX ( Other Identifier: UC Davis )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms