NCT06569017

Brief Summary

Breastfeeding is the gold standard in infant nutrition in the first 12 months of life (1). Breastfeeding self-efficacy perception is one of the most important factors affecting mothers\' breastfeeding duration and success in the postpartum period (2,3).Although AI has traditionally been the domain of powerful mainframes and data centers, new approaches have the capacity to put the power of AI directly into the hands of patients (4).Therefore, considering the importance of breastfeeding education and counseling, this study will determine the effect of training and use of a mobile application-supported artificial intelligence tool and nurse-led online breastfeeding counseling on mothers; breastfeeding self-efficacy perception, breastfeeding success, infant feeding attitude and postpartum depression levels. Thus, the effectiveness of the artificial intelligence tool and nurse-led breastfeeding counseling will be compared.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 19, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

artificial intelligencenurse ledbreastfeeding

Outcome Measures

Primary Outcomes (1)

  • mothers' breastfeeding self-efficacy perception

    Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured.

    Measurements will be completed by 12 months

Secondary Outcomes (1)

  • mothers' breastfeeding success

    Measurements will be completed by 12 months

Other Outcomes (1)

  • mothers' depression level

    Measurements will be completed by 12 months

Study Arms (3)

1) Artificial intelligence supported working group

EXPERIMENTAL

Pregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones.

Other: 1) Artificial intelligence supported working group

3) Observation group

NO INTERVENTION

32-37 in the observation group. A breastfeeding education booklet will be given to primiparous pregnant women at the gestational age.

2)Nurse-led online breastfeeding counseling group

EXPERIMENTAL

32-37. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session.

Other: Online breastfeeding counseling group led by a nurse

Interventions

Pregnant women will be a personal information form, breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa infant nutrition attitude scale and Edinburgh postpartum depression scale. Pregnant women in the artificial intelligence-supported study group were aged 32-37. Starting from the first week of pregnancy, a mobile breastfeeding consultancy application supported by IOS and Android will be installed on smart phones. Pregnant women will be expected to use this application actively until birth and submit their questions about breastfeeding to this artificial intelligence-supported mobile application and receive instant answers. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month.

1) Artificial intelligence supported working group

The forms that will be applied to pregnant women in all three groups at the first meeting will also be applied to this group. 32-37 in the nurse-led online breastfeeding counseling group. Primiparous pregnant women at the gestational age will be offered 1.5 hours of breastfeeding counseling by one of the researchers, between the 32nd and 37th weeks of pregnancy, with the participation of small groups of five pregnant women in each interactive session. Pregnant women in this group will receive only one session of breastfeeding training. These trainings, which will be given by the nurse, will be carried out online via video call via WhatsApp application. After these applications, the breastfeeding diagnosis and evaluation scale, postnatal breastfeeding self-efficacy scale, Lowa baby nutrition attitude scale and Edinburgh postpartum depression scale will be applied again to pregnant women on the first postpartum day, sixth day, third week and third month.

2)Nurse-led online breastfeeding counseling group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsıt must be a woman to participate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The pregnant woman is willing to participate in the research,
  • The pregnant woman must have an informed written voluntary consent form,
  • The pregnant woman is over 18 years of age,
  • The pregnant woman speaks and understands Turkish,
  • Having the pregnant woman\'s first baby (primiparous),
  • The pregnant woman is planning to give birth in the hospital where she came for pregnancy check-up,
  • The pregnant woman must have received breastfeeding training at the family health center to which she is affiliated.
  • The baby does not have a disease that would prevent sucking (cleft palate, cleft lip, etc.),
  • The baby is born older than the 37th week of pregnancy,
  • The baby\'s birth weight is 2500 g and above, and the APGAR score is 7 and above at the 5th minute.

You may not qualify if:

  • The pregnant woman has mental retardation that affects her ability to understand and comprehend,
  • Multiple pregnancy,
  • The pregnant woman has gestational disorders such as preeclampsia, eclampsia and a history of gestational diabetes,
  • The pregnant woman has a diagnosed psychiatric disorder,
  • The pregnant woman receives support from a private breastfeeding consultant,
  • Taking the baby to the neonatal intensive care unit after birth,
  • The baby is born before the 37th week of pregnancy,
  • Loss of communication with pregnant women who were contacted before birth, after birth,
  • Pregnant women who do not use smartphones,
  • Pregnant women who have an application installed on their phones but have never used the application until the birth,
  • Pregnant women who were given an educational booklet but did not look at the booklet until the birth,
  • Pregnant women who do not attend the 1.5-hour training or who have to leave the training halfway will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor dr.

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 23, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share