Clinical Trials Directory

Trials / Completed

CompletedNCT04376021

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Nurturely · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBabywearingIncrease mother-infant physical contact through babywearing

Timeline

Start date
2018-02-06
Primary completion
2019-06-26
Completion
2019-06-26
First posted
2020-05-06
Last updated
2020-05-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04376021. Inclusion in this directory is not an endorsement.