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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816383
• Other study ID #: 1699671
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breastfeeding Rates	We will assess the exclusive breastfeeding rates at 6 months postpartum	6 months postpartum
Other	Breastfeeding Rates	We will assess the exclusive breastfeeding rates at 12 months postpartum	12 months postpartum
Primary	Breastfeeding duration	We will assess total breastfeeding duration	12 months postpartum
Secondary	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