Effect of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration

NCT06585111 | Completed DMC

• 1 other identifier: EGEU-SBF-CK-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. Women in the intervention group received breastfeeding education using motivational interviewing techniques, while women in the control group received routine clinical education and no intervention. Hypotheses of the study: H1: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding self-efficacy than the control group. H2: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding intentions than the control group. H3: Postnatal breastfeeding self-efficacy of women who received individual intervention based on SESY model is higher than the control group. H4: Breastfeeding motivation of women who received individual intervention based on the SESY model is higher than the control group. H5: Women who received individual intervention based on the SESY model had higher rates of exclusive breastfeeding than the control group. The women in the intervention group were given breastfeeding education with motivational interviewing techniques at 28-38 weeks of pregnancy in the prenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. The women in the control group did not receive any training by the researcher.

Conditions

Breast Feeding

Keywords

Breas Feeding; Twins; Motivational Interviewing; Self Efficacy

Outcome Measures

Primary Outcomes (1)

• Breastfeeding duration of twin babies until the sixth month postpartum after counseling

  The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.

  Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months

Secondary Outcomes (5)

• Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth

  postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months

• Breastfeeding Intention Level

  In the prenatal period between 28-38 weeks of gestation

• Prenatal Breastfeeding Self Efficacy Level

  In the Prenatal period between 28-38 weeks of gestation

• Postnatal Breastfeeding Self Efficacy Scale Level

  Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.

• Breastfeeding Motivation Level in Mothers of Twin Babies

  1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum

Study Arms (2)

Breastfeeding Education

EXPERIMENTAL

Women in the intervention group received breastfeeding education through six motivational interviews based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month).

Other: Intervention

Control

NO INTERVENTION

The women in the control group received six follow-ups based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month).

Interventions

Intervention OTHER

In the first motivational interview, the "HAPA Model Prenatal Motivation Interview Questionnaire", the first part of the "Personal Information Form", the "Prenatal Breastfeeding Self-Efficacy Scale", and the "Breastfeeding Intention Scale for Pregnant Women Expecting Twins" were applied. A brochure on breastfeeding twin babies prepared by the researcher was distributed to women. In the second interview, the "HAPA Model Postpartum Motivation Interview Scale", the second part of which was the "Personal Information Form", "Breastfeeding Follow-up Form", "Breastfeeding Motivation Scale" and "Postpartum Breastfeeding Self-Efficacy Scale" were applied. In the third meeting, the "Breastfeeding Follow-up Form" was applied. "Breastfeeding Motivation Scale", "Postpartum Breastfeeding Self-Efficacy Scale" and "Breastfeeding Follow-up Form" were applied in the fourth and fifth interviews, and "Breastfeeding Follow-up Form" was applied in the sixth interview.

Breastfeeding Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who agreed to participate in the study,
• years of age or older,
• Can speak and understand Turkish,
• Can read and write,
• Mothers whose breasts are suitable for breastfeeding
• Weeks between (28+0)-(37+6) of pregnancy

You may not qualify if:

• The baby has an anomaly in the mouth area
• The woman has language and communication problems
• The breasts are not suitable for breastfeeding (history of mastectomy surgery on both breasts)
• The mother or the baby is taking medication that prevents breastfeeding
• The woman has a previously diagnosed psychiatric disorder
• The mother does not plan to breastfeed her babies

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Oya Kavlak, Prof. Dr.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Model Details: The participants were divided into two groups: intervention and control groups. Interventions and follow-ups were carried out in six determined time periods.

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: September 5, 2024
• Study Start: September 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Participant data will be shared with other researchers after the study is published (after 6 months).
• Access Criteria: The national thesis center will make the thesis available to other researchers six months after approval.

Locations

TU (1)