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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04816383
Enrollment
93
Registered
2021-03-25
Start date
2021-07-01
Completion date
2023-06-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

smartphone application, breastfeeding, breastfeeding self-efficacy

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.

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 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.

Interventions

OTHERBreastfeeding 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.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

Control group will usual breastfeeding care (counseling by provider, access to lactation consultant, etc) Interventional group will receive usual care plus the breastfeeding application introduced between 32 to 36 weeks estimated gestational age.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding duration12 months postpartumWe will assess total breastfeeding duration

Secondary

MeasureTime frameDescription
Breastfeeding Self-Efficacy Rates12 months postpartumThe breastfeeding self-efficacy short form is a validated, standardized form to assess participants' sense of breastfeeding self-efficacy.

Other

MeasureTime frameDescription
Breastfeeding Rates6 months postpartumWe will assess the exclusive breastfeeding rates at 6 months postpartum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026