Clinical trial NCT05673317: A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy
Official title: A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Breastfeeding Self-Efficacy
Technology
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Breastfeeding Self-Efficacy Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Breastfeeding rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References: