A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy

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

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: "Breastfeeding at AU" Apple-Based Smartphone Application

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

HIV)

• Mothers unable to breastfeed secondary to contraindicated medications
• Mothers of infants up for adoption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; The participant will receive usual breastfeeding care such as counseling by her physician, access to lactation consults, nursing assistance in the hospital, access to our online resources.
Experimental: Experimental Arm; The participant will receive usual breastfeeding care such as counseling by her physician, access to lactation consults, nursing assistance in the hospital, access to our online resources. The participant will also receive the Apple breastfeeding application in the office once enrolled in the study between 32 to 36 weeks gestation. The participant will be taught how to use the application, and will have access to the study to continue use throughout the duration of follow-up.	Other: "Breastfeeding at AU" Apple-Based Smartphone Application; This is a free Apple-Based Smartphone Application the participant can download. In the application, there is information and tips for breastfeeding success and continuation, as well as information on additional resources both online and in the community as a whole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	We will assess total breastfeeding duration	12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Self-Efficacy Rates	The breastfeeding self-efficacy short form is a validated, standardized form to assess participants' sense of breastfeeding self-efficacy.	12 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Rates	We will assess the exclusive breastfeeding rates at 6 months postpartum	6 months postpartum
Breastfeeding Rates	We will assess the exclusive breastfeeding rates at 12 months postpartum	12 months postpartum

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 20, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: breastfeeding; smartphone application; breastfeeding self-efficacy
• Other Study ID Numbers: 1699671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No