Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

Sponsor
Nurturely (Other)
Overall Status
Completed
CT.gov ID
NCT04376021
Collaborator
Project Concern International (Other)
101
1
2
16.6
6.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Babywearing
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Feb 6, 2018
Actual Primary Completion Date :
Jun 26, 2019
Actual Study Completion Date :
Jun 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical Contact

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

Behavioral: Babywearing
Increase mother-infant physical contact through babywearing

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

  1. Proportion of infant feeds coming from breastmilk versus formula [Postpartum Week 24]

    Self-report feeding log

Secondary Outcome Measures

  1. Score on Edinburgh Postnatal Depression Scale (EPDS) [Postpartum Week 6]

    Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased depressive symptoms

  2. Score on the Mother-Infant Bonding Questionnaire [Postpartum Week 24]

    Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased problems with bonding

  3. Score on the Proximal Care Beliefs Questionnaire [Postpartum Week 12]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Project Concern International San Diego California United States 92105

Sponsors and Collaborators

  • Nurturely
  • Project Concern International

Investigators

  • Principal Investigator: Emily E Little, PhD, Nurturely

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Little, Founder & Director, Nurturely
ClinicalTrials.gov Identifier:
NCT04376021
Other Study ID Numbers:
  • 28
First Posted:
May 6, 2020
Last Update Posted:
May 12, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2020