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OpenTrials
Completed

NCT Number: NCT04376021

Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

To test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Project Concern International

San Diego, California, 92105, United States

About this study

One hundred mothers participating in the California Border Healthy Start (CBHS) program will be randomly assigned to the physical contact group or the control group. Mothers in the physical contact group will be provided with an infant carrier to use from birth to facilitate increased mother-infant physical contact. In the control group, mothers will be provided with an infant carrier, but will not receive the carrier until postpartum week 24, once study measures have been collected. This type of multiple-baseline design will allow the investigators to objectively assess the effect of physical contact during the first six months, but will also ensure that mothers in both groups have the opportunity to benefit from the potentially positive intervention of a high quality infant carrier to promote increased mother-infant physical contact. The two groups will be compared on: 1) likelihood of exclusive breastfeeding, 2) extent of breastfeeding exclusivity (proportion of feeds that are breastmilk versus formula or other), 3) likelihood of initiating feeding in response to hunger cues versus crying (i.e., maternal responsiveness during feeding), 4) maternal score on the Edinburgh Postnatal Depression Scale (EPDS), 5) prevalence of breastfeeding difficulties, 6) score on the Mother-Infant Bonding Scale, and 7) beliefs about breastfeeding and infant care.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

To be eligible to participate in this study, participants:

  • Must be a current participant in the CBHS program
  • Must be 18 years of age or older
  • Must be currently pregnant
  • Must be fluent in either Spanish or English
  • Must have consistent access to a smartphone with internet access (to fill out surveys and feeding logs)
  • Must have a functioning email address Must be willing to share certain personal information with the researchers

Exclusion criteria

  • Having a birth that does not result in a live, healthy, singleton infant.

Treatment and study plan

Babywearing

Behavioral

Increase mother-infant physical contact through babywearing

Primary outcomes

  1. Proportion of infant feeds coming from breastmilk versus formula

    Time frame: Postpartum Week 24

    Self-report feeding log

Secondary outcomes

  1. Score on Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Postpartum Week 6

    Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased depressive symptoms

  2. Score on the Mother-Infant Bonding Questionnaire

    Time frame: Postpartum Week 24

    Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased problems with bonding

  3. Score on the Proximal Care Beliefs Questionnaire

    Time frame: Postpartum Week 12

    Standardized self-report questionnaire with a possible score from 6-30, with a higher score indicating increased alignment with the caretaking practices of proximal care culture

Sponsors and collaborators

Lead sponsor

Nurturely

Other

Collaborators

  • Project Concern International

Registry information

Official study title

The Effect of Physical Contact on Maternal Responsiveness and Breastfeeding Outcomes Among Low Income Mothers Participating in the California Border Healthy Start Program

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 12, 2020

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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