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Completed

NCT Number: NCT02438878

Supporting Baby Behavior Through Pediatric Offices

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.

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Key information

Conditions

Infant Behavior Behavior Behavior, Animal Body Weight Breast Feeding Breastfeeding Child Behavior Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby Behavior

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 8, 2015
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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