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

NCT04816383 | Completed

• 1 other identifier: 1699671
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

smartphone application; breastfeeding; breastfeeding self-efficacy

Outcome Measures

Primary Outcomes (1)

• Breastfeeding duration

  We will assess total breastfeeding duration

  12 months postpartum

Secondary Outcomes (1)

• Breastfeeding Self-Efficacy Rates

  12 months postpartum

Other Outcomes (2)

• Breastfeeding Rates

  6 months postpartum

• Breastfeeding Rates

  12 months postpartum

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

"Breastfeeding at AU" Apple-Based Smartphone Application OTHER

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.

Experimental Arm

Eligibility Criteria

• Gender Eligibility Details: This project is aimed at postpartum women and the application's effect on breastfeeding rates.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• de Mello Sa SR, Wang Z, Sapkalova V, Sullivan M, Saucedo Baza A, Delgado P, Looney S, Zahler-Miller C. A smartphone-based application to improve breastfeeding duration and self-efficacy: a randomized controlled clinical trial. Women Health. 2025 Feb;65(2):154-166. doi: 10.1080/03630242.2024.2448519. Epub 2025 Jan 3.

  PMID: 39748676 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant cannot be blinded as they will be using the application. The investigator cannot be blinded as they have to provide the application to the patient, teach them how to use it, and perform their surveys about the application use. The outcomes assessor and care provider will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control group will usual breastfeeding care (counseling by provider, access to lactation consultant, etc) Interventional group will receive usual care plus the breastfeeding application introduced between 32 to 36 weeks estimated gestational age.

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 25, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)