NCT04705675

Brief Summary

H1a: The breastfeeding education has an effect the behaviors of mothers toward breastfeeding. H1b: The breastfeeding education has an effect on the use of traditional breastfeeding practices. H0a: The breastfeeding education has not an effect the behaviors of mothers toward breastfeeding. H0b: The breastfeeding education has not an effect on the use of traditional breastfeeding practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 4, 2021

Last Update Submit

January 8, 2021

Conditions

BreastfeedingBreasfeeding Traditional PracticesPost Procedural Discharge

Keywords

BreastfeedingEducationBehaviorTraditional practices

Outcome Measures

Primary Outcomes (2)

  • Pre-Education Mothers' traditional breastfeeding practices

    The Breastfeeding Behaviors Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The questionnaire for Breastfeeding Behaviors included the following questions: Education about mother's milk and breastfeeding, When did you first breastfeed your baby after birth? Have you given your baby the first milk from your breast? Has your baby been given any food other than breast milk after birth? Why are you giving other food to your baby? Have you continued to feed your baby any other food? Do you give your baby water after breastfeeding? Breastfeeding Length (Daily)-Frequency (Daily)-Position-Latching, Having Problems with Breastfeeding, b. How long do you intend to breastfeed your baby?

    20 minute after the admittance to the family health centers

  • Pre-Education Breastfeeding behavior

    Traditional Practices Assessment Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The Mother's Traditional Breastfeeding Practices Assessment Form included the following questions: Are there any traditional practices you use for breastfeeding? Do you think the traditional Practices you use for breastfeeding are useful? Who suggested traditional practices regarding breastfeeding? Do you voluntarily use traditional breastfeeding practices? Are There Foods You Consume to Increase Breast Milk? Who recommended the foods you consume to increase breast milk? Do you think the Food You Consume to Increase Breast Milk is beneficial? Do you voluntarily consume the foods you consume to increase breast milk?

    20 minute after the admittance to the family health centers

Secondary Outcomes (2)

  • Post-Education

    1 month following the breastfeeding education.

  • Post-Education

    1 month following the breasfeeding education.

Study Arms (2)

Experimental Group

EXPERIMENTAL

The mothers in the experimental group (152) were administered.

Behavioral: Breastfeeding Education

Control Group

NO INTERVENTION

The mothers in the control group (152) were administered.

Interventions

Breastfeeding EducationBEHAVIORAL

The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To receive breasfeeding education
  • To have singleton birth or one infant
  • Not have complications postpartum period
  • Not have chronic diseases or mental disorders
  • Older than 18 years
  • To voluntary to participate
  • To know how to read, write and speak in Turkish
  • To stay within this study until the end
  • To have a newborn with no complications
  • To have a 0-6 months healthy infants

You may not qualify if:

  • Not receive breasfeeding education
  • Having multiple birth or more than a baby
  • Having complications postpartum period
  • Having chronic diseases or mental disorders
  • Younger than 18 years
  • To refuse to participate
  • Not knowing how to read, write and speak Turkish
  • To leave early this study
  • Having a newborn with complications
  • Having a baby in need of medical care
  • To have a older than 0-6 months infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

Related Publications (8)

  • Zielinska MA, Sobczak A, Hamulka J. Breastfeeding knowledge and exclusive breastfeeding of infants in first six months of life. Rocz Panstw Zakl Hig. 2017;68(1):51-59.

    PMID: 28303701BACKGROUND

  • Bellu R, Condo M. Breastfeeding promotion: evidence and problems. Pediatr Med Chir. 2017 Jun 28;39(2):156. doi: 10.4081/pmc.2017.156.

    PMID: 28673077BACKGROUND

  • Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.

    PMID: 31764775BACKGROUND

  • Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.

    PMID: 27917213BACKGROUND

  • Sandoval Jurado L, Jimenez Baez MV, Olivares Juarez S, de la Cruz Olvera T. [Breastfeeding, complementary feeding and risk of childhood obesity]. Aten Primaria. 2016 Nov;48(9):572-578. doi: 10.1016/j.aprim.2015.10.004. Epub 2016 Feb 12. Spanish.

    PMID: 26880166BACKGROUND

  • McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.

    PMID: 28244064BACKGROUND

  • Hay G, Baerug AB. The benefits of exclusive breastfeeding up to six months. Tidsskr Nor Laegeforen. 2019 May 3;139(9). doi: 10.4045/tidsskr.19.0105. Print 2019 May 28. No abstract available. English, Norwegian.

    PMID: 31140258BACKGROUND

  • Del Ciampo LA, Del Ciampo IRL. Breastfeeding and the Benefits of Lactation for Women's Health. Rev Bras Ginecol Obstet. 2018 Jun;40(6):354-359. doi: 10.1055/s-0038-1657766. Epub 2018 Jul 6.

    PMID: 29980160BACKGROUND

MeSH Terms

Conditions

Breast FeedingBehavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know which group they were allocated. The participants will be blind when they attend breastfeeding education.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was designed to be parallel group, randomized controlled study (1:1). Power was calculated using the GPower 3.1 program. In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.A total of 304 mothers were evenly and homogeneously assigned to both groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 12, 2021

Study Start

February 1, 2018

Primary Completion

June 4, 2018

Study Completion

October 31, 2018

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Starting 6 months after publication
Access Criteria
If study' IPD are used, my article should be cited.

Locations

TU(1)