Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

NCT ID: NCT04376021

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2019-06-26

Brief Summary

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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

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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

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Breastfeeding, Exclusive Mother-Infant Interaction Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Physical Contact

Baby carrier (and education) provided to mother to increase physical contact with baby

Group Type EXPERIMENTAL

Babywearing

Intervention Type BEHAVIORAL

Increase mother-infant physical contact through babywearing

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Babywearing

Increase mother-infant physical contact through babywearing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Project Concern International

OTHER

Sponsor Role collaborator

Nurturely

OTHER

Sponsor Role lead

Responsible Party

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Emily Little

Founder & Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily E Little, PhD

Role: PRINCIPAL_INVESTIGATOR

Nurturely

Locations

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Project Concern International

San Diego, California, United States

Site Status

Countries

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United States

References

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Little EE, Bain L, Hahn-Holbrook J. Randomized controlled trial to prevent postpartum depressive symptomatology: An infant carrier intervention. J Affect Disord. 2023 Nov 1;340:871-876. doi: 10.1016/j.jad.2023.08.044. Epub 2023 Aug 15.

Reference Type DERIVED
PMID: 37586649 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34193622 (View on PubMed)

Other Identifiers

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28

Identifier Type: -

Identifier Source: org_study_id

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