Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Breastfeeding, Exclusive; Mother-Infant Interaction
• Intervention / Treatment: Behavioral: Babywearing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92105
      • Project Concern International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention
EXPERIMENTAL: Physical Contact; Baby carrier (and education) provided to mother to increase physical contact with baby	Behavioral: Babywearing; Increase mother-infant physical contact through babywearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of infant feeds coming from breastmilk versus formula	Self-report feeding log	Postpartum Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Edinburgh Postnatal Depression Scale (EPDS)	Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased depressive symptoms	Postpartum Week 6
Score on the Mother-Infant Bonding Questionnaire	Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased problems with bonding	Postpartum Week 24
Score on the Proximal Care Beliefs Questionnaire	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	Postpartum Week 12

Collaborators and Investigators

• Sponsor: Nurturely
• Collaborators: Project Concern International
• Investigators: Principal Investigator: Emily E Little, PhD, Nurturely

Publications and helpful links

General Publications

• Little EE, Cioffi CC, Bain L, Legare CH, Hahn-Holbrook J. An Infant Carrier Intervention and Breastfeeding Duration: A Randomized Controlled Trial. Pediatrics. 2021 Jul;148(1):e2020049717. doi: 10.1542/peds.2020-049717. Epub 2021 Jun 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2018
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No