Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

Postpartum Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376021
• Other study ID #: 28
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: June 26, 2019

Study information

• Verified date: May 2020
• Source: Nurturely
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding, Exclusive
• Depression, Postpartum
• Mother-Infant Interaction
• Postpartum Depression

Intervention

Behavioral:
• Babywearing
Increase mother-infant physical contact through babywearing

Locations

Country	Name	City	State
United States	Project Concern International	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Nurturely	Project Concern International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of infant feeds coming from breastmilk versus formula	Self-report feeding log	Postpartum Week 24
Secondary	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
Secondary	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
Secondary	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