A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy

NCT05673317 | Completed

• 1 other identifier: 1505563
• Study Type: interventional
• Target: 40
• 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 (primary outcome).

Conditions

Breastfeeding

Keywords

Breastfeeding; Breastfeeding Self-Efficacy; Technology

Outcome Measures

Primary Outcomes (1)

• Breastfeeding Self-Efficacy Score

  The breastfeeding self-efficacy short form is a validated, standardized form to assess participants' sense of breastfeeding self-efficacy.

  6 weeks

Secondary Outcomes (1)

• Breastfeeding rate

  6 weeks

Study Arms (2)

Experiment 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 breastfeeding application at admission to labor and delivery or in the immediate postpartum period. 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" 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" 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.

Experiment Arm

Eligibility Criteria

• Gender Eligibility Details: Must be a genotypic female who gave birth with intention to breastfeed their infant to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients intending to breastfeed receiving prenatal care at Augusta University.
• 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
• Patients unable to breastfeed secondary to contraindicated communicable disease (i.e.
• HIV)
• Patients unable to breastfeed secondary to contraindicated medications
• Patients of infants up for adoption

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group received usual breastfeeding care (counseling by provider, access to lactation consultant, etc). Interventional received usual care plus the breastfeeding application introduced at the time of delivery or within 1 week postpartum.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 6, 2023
• Study Start: May 29, 2020
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 5 years after the study
• Access Criteria: Email czahlermiller@augusta.edu

Locations

US (1)