A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy

NCT ID: NCT05673317

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2020-09-24

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).

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 controlled pilot study. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve breastfeeding rates, duration, and self-efficacy if offered to at the time of delivery or within the first week postpartum. This will be assessed by comparing initial self-efficacy survey results (within 1 week postpartum) with survey results at 4 to 6 weeks postpartum.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experiment 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 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.

Group Type: EXPERIMENTAL

"Breastfeeding at AU" Smartphone Application

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"Breastfeeding at AU" 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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
• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Augusta University

Augusta, Georgia, United States

Countries

United States

Other Identifiers

1505563

Identifier Type: -

Identifier Source: org_study_id