Clinical trial NCT04376021: Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity
Official title: The Effect of Physical Contact on Maternal Responsiveness and Breastfeeding Outcomes Among Low Income Mothers Participating in the California Border Healthy Start Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Mother-Infant Interaction
Postpartum Depression
Lead sponsor: Nurturely
Sponsor class: OTHER
Collaborators: name: Project Concern International
First posted: 2020-05-06
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of infant feeds coming from breastmilk versus formula
timeFrame: Postpartum Week 24
Secondary outcomes:
measure: Score on Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Postpartum Week 6
measure: Score on the Mother-Infant Bonding Questionnaire
timeFrame: Postpartum Week 24
measure: Score on the Proximal Care Beliefs Questionnaire
timeFrame: Postpartum Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Project Concern International
state: California
Study officials:
affiliation: Nurturely
name: Emily E Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.