Skip to main content
OpenTrials
Completed

NCT Number: NCT04816383

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

Primary outcomes

  1. Breastfeeding duration

    Time frame: 12 months postpartum

    We will assess total breastfeeding duration

Secondary outcomes

  1. Breastfeeding Self-Efficacy Rates

    Time frame: 12 months postpartum

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

Other outcomes

  1. Breastfeeding Rates

    Time frame: 6 months postpartum

    We will assess the exclusive breastfeeding rates at 6 months postpartum

  2. Breastfeeding Rates

    Time frame: 12 months postpartum

    We will assess the exclusive breastfeeding rates at 12 months postpartum

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2021
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.