Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

Study Overview
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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.

Official Title
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The Effect of Physical Contact on Maternal Responsiveness and Breastfeeding Outcomes Among Low Income Mothers Participating in the California Border Healthy Start Program

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

Intervention / Treatment
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* Behavioral: Babywearing


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Contact<br>Baby carrier (and education) provided to mother to increase physical contact with baby | Behavioral: Babywearing<br>* Increase mother-infant physical contact through babywearing<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infant feeds coming from breastmilk versus formula | Self-report feeding log | Postpartum Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |