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Clinical Trials/NCT04376021
NCT04376021
Completed
N/A

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

Nurturely1 site in 1 country101 target enrollmentFebruary 6, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding, Exclusive
Sponsor
Nurturely
Enrollment
101
Locations
1
Primary Endpoint
Proportion of infant feeds coming from breastmilk versus formula
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 6, 2018
End Date
June 26, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Nurturely
Responsible Party
Principal Investigator
Principal Investigator

Emily Little

Founder & Director

Nurturely

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.

Outcomes

Primary Outcomes

Proportion of infant feeds coming from breastmilk versus formula

Time Frame: Postpartum Week 24

Self-report feeding log

Secondary Outcomes

  • Score on the Proximal Care Beliefs Questionnaire(Postpartum Week 12)
  • Score on Edinburgh Postnatal Depression Scale (EPDS)(Postpartum Week 6)
  • Score on the Mother-Infant Bonding Questionnaire(Postpartum Week 24)

Study Sites (1)

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