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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04376021
Enrollment
101
Registered
2020-05-06
Start date
2018-02-06
Completion date
2019-06-26
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Exclusive, Mother-Infant Interaction, Postpartum Depression

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.

Interventions

BEHAVIORALBabywearing

Increase mother-infant physical contact through babywearing

Sponsors

Project Concern International
CollaboratorOTHER
Nurturely
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of infant feeds coming from breastmilk versus formulaPostpartum Week 24Self-report feeding log

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026