Skip to main content
Clinical Trials/NCT04816383
NCT04816383
Completed
Not Applicable

A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy: A Randomized Controlled Clinical Trial

Augusta University1 site in 1 country93 target enrollmentJuly 1, 2021
ConditionsBreastfeeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Augusta University
Enrollment
93
Locations
1
Primary Endpoint
Breastfeeding duration
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.

Detailed Description

The benefits of breastfeeding for both mother and neonate have been well documented and extensively researched. Breastfeeding rates remain suboptimal despite known advantages including reduced lifetime risk of maternal ovarian cancer, more rapid return to pre-gestational weight, improvement in maternal/neonatal bonding, reduction in neonatal allergic/immunologic conditions. Both non-modifiable and modifiable factors affecting a mother's decision regarding breastfeeding have been identified. Modifiable factors include breastfeeding knowledge, self-efficacy, and confidence. Breastfeeding self-efficacy has been positively correlated with breastfeeding duration. There is a lack of local data on breastfeeding rates, duration, and self-efficacy in the Augusta University women's health population as well as a lack of documented improvement of these factors following educational programs. Our study aims to create a program that is easily accessible and available to our patient population in the form of a free application available on Apple devices capable of accessing the internet (e.g., i-phone, i-pad, etc.). This study will be a randomized control trial. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve long-term breastfeeding rates, duration, and self-efficacy if offered to patients at 32 through 36 weeks gestation. This will be assessed by comparing initial self-efficacy survey results with survey results at 12 months postpartum for the intervention versus control groups. We will also measure breastfeeding duration during the first 12 months postpartum and exclusive breastfeeding rates at 6 months postpartum.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolyn Zahler-Miller

Assistant Professor

Augusta University

Eligibility Criteria

Inclusion Criteria

  • Primiparous and multiparous females receiving prenatal care at Augusta University Obstetrics and Gynecology clinic at 32 through 36 weeks gestation.
  • No documented anatomic differences in mother's chest anatomy.
  • Access to the internet via an Apple® device (such as i-phone or i-pad).
  • Delivery at Augusta University Medical Center

Exclusion Criteria

  • Significant maternal intrapartum or postpartum complications (i.e., postpartum hemorrhage \> 2000 mL, uterine inversion, retained products, ICU admission, postpartum psychosis).
  • Infants admitted to neonatal intensive care unit \>48 hours
  • Pre-term deliveries prior to 37 weeks gestation
  • Infants with cleft palate, or other palate/facial defects
  • Patients without email access or internet access
  • Patients without an Apple® device (i-phone, i-pad)
  • Non-English speaker
  • Mothers unable to breastfeed secondary to contraindicated communicable disease (i.e.
  • Mothers unable to breastfeed secondary to contraindicated medications
  • Mothers of infants up for adoption

Outcomes

Primary Outcomes

Breastfeeding duration

Time Frame: 12 months postpartum

We will assess total breastfeeding duration

Secondary Outcomes

  • Breastfeeding Self-Efficacy Rates(12 months postpartum)

Study Sites (1)

Loading locations...

Similar Trials