Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity
Primary Purpose
Breastfeeding, Exclusive, Mother-Infant Interaction, Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Babywearing
Sponsored by
About this trial
This is an interventional basic science trial for Breastfeeding, Exclusive
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.
Sites / Locations
- Project Concern International
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical Contact
Control
Arm Description
Baby carrier (and education) provided to mother to increase physical contact with baby
No intervention
Outcomes
Primary Outcome Measures
Proportion of infant feeds coming from breastmilk versus formula
Self-report feeding log
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT04376021
First Posted
March 4, 2018
Last Updated
May 9, 2020
Sponsor
Nurturely
Collaborators
Project Concern International
1. Study Identification
Unique Protocol Identification Number
NCT04376021
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nurturely
Collaborators
Project Concern International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Exclusive, Mother-Infant Interaction, Postpartum Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Contact
Arm Type
Experimental
Arm Description
Baby carrier (and education) provided to mother to increase physical contact with baby
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Babywearing
Intervention Description
Increase mother-infant physical contact through babywearing
Primary Outcome Measure Information:
Title
Proportion of infant feeds coming from breastmilk versus formula
Description
Self-report feeding log
Time Frame
Postpartum Week 24
Secondary Outcome Measure Information:
Title
Score on Edinburgh Postnatal Depression Scale (EPDS)
Description
Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased depressive symptoms
Time Frame
Postpartum Week 6
Title
Score on the Mother-Infant Bonding Questionnaire
Description
Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased problems with bonding
Time Frame
Postpartum Week 24
Title
Score on the Proximal Care Beliefs Questionnaire
Description
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
Time Frame
Postpartum Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily E Little, PhD
Organizational Affiliation
Nurturely
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Concern International
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34193622
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.
Results Reference
derived
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Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity
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