BreastfeedingNCT04816383
A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy
A study testing "Breastfeeding at AU" Apple-Based Smartphone Application in people with Breastfeeding, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- "Breastfeeding at AU" Apple-Based Smartphone Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy: A Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- "Breastfeeding at AU" Apple-Based Smartphone Application
- Keywords
- smartphone application, breastfeeding, breastfeeding self-efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Breastfeeding at AU" Apple-Based Smartphone ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 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 Apple breastfeeding application in the office once enrolled in the study between 32 to 36 weeks gestation. 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. Receives: Other: "Breastfeeding at AU" Apple-Based Smartphone Application |
| Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration
We will assess total breastfeeding duration
Measured: 12 months postpartum
Secondary outcomes (1)
Breastfeeding Self-Efficacy Rates
The breastfeeding self-efficacy short form is a validated, standardized form to assess participants' sense of breastfeeding self-efficacy.
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jul 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Zahler-Miller, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816383
- Sponsor's protocol ID
- 1699671
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Mello Sa SR, Wang Z, Sapkalova V, Sullivan M, Saucedo Baza A, Delgado P, Looney S, Zahler-Miller C. A smartphone-based application to improve breastfeeding duration and self-efficacy: a randomized controlled clinical trial. Women Health. 2025 Feb;65(2):154-166. doi: 10.1080/03630242.2024.2448519. Epub 2025 Jan 3.
PubMed 39748676
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04816383
- Acronym / sponsor ID
- 1699671
- Conditions
- Breastfeeding
- Keywords
- smartphone application, breastfeeding, breastfeeding self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: "Breastfeeding at AU" Apple-Based Smartphone ApplicationThe 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 Apple breastfeeding application in the office once enrolled in the study between 32 to 36 weeks gestation. 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. |
| Control Arm | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Breastfeeding at AU" Apple-Based Smartphone ApplicationThis 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. | Other | Experimental Arm |
Primary outcome
Breastfeeding duration
Time frame: 12 months postpartum
We will assess total breastfeeding duration
1 secondary outcome
Breastfeeding Self-Efficacy Rates
Time frame: 12 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 39748676de Mello Sa SR, Wang Z, Sapkalova V, Sullivan M, Saucedo Baza A, Delgado P, Looney S, Zahler-Miller C. A smartphone-based application to improve breastfeeding duration and self-efficacy: a randomized controlled clinical trial. Women Health. 2025 Feb;65(2):154-166. doi: 10.1080/03630242.2024.2448519. Epub 2025 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Breastfeeding at AU" Apple-Based Smartphone Application in people with Breastfeeding, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding duration (time frame: 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.