NCT04906122

Brief Summary

Adequate nutrition during infancy and early childhood are fundamental to the development of a child. It is well recognized that the period from birth to two years of age is a "critical window" for the promotion of optimal growth, health, and behavioral development. The World Health Organization, the American Academy of Pediatrics, and the National Association of Pediatric Nursing Practitioners, UNICEF and CDC acknowledge that breastfeeding is the ideal diet for babies and recommend exclusive breastfeeding for the first 6 months of life, and continuing breastfeeding until the age of 2. postpartum breastfeeding is widespread in Turkey. According to the 2018 Turkey Demographic and Health Survey (2018 TDHS) data, 98% of the last-born children in the two years before the study were breastfed. However, 41% of children younger than six months are only fed with breast milk. In many studies, it is stated that the education of both the mother, her relatives and the healthcare personnel plays a key role in breastfeeding success. Postpartum social support is important for the protection of both mother and baby health. Culturally, in Turkish society, the postpartum period, which mothers and grandmothers spend more often together, and the positive support of the mother are very important for both the short and long term maternal and infant health. In the literature, it is emphasized that the most important factors in starting additional food and formula in the early period are the influence of the immediate environment and family and that grandmothers are vital in baby care and feeding In addition, inadequate or misguided grandmothers due to lack of knowledge and traditional attitudes during this period can have a negative effect on the continuation of breastfeeding. Although there are studies in the literature on breastfeeding training given to mothers and healthcare personnel, there are very few studies on inclusive breastfeeding counseling for grandmothers who have a primary support role. However, there is RCT study regarding the application of breastfeeding counseling involving grandmothers who have been followed up in a clinical setting, and no project has been found in our country on this subject. With this planned project, this effect will be investigated for the first time. For this reason, it is thought that the results of this project will have positive effects on the strengthening of breastfeeding and mother-baby health and will have extremely important outputs for its applicability in clinical and public health centers. In this direction, this research aims to increase only breast milk intake in the first 6 months in the short term and to have longer breastfeeding periods in the long term. It was planned for breastfeeding counseling to empower grandmothers who support postnatal mother and baby care, increase their knowledge about breastfeeding, and support mothers by developing a positive attitude. The research was planned as a randomized controlled study. Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group. The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling. In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined. As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

March 20, 2021

Last Update Submit

May 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Iowa Infant Feeding Attitude Scale

    The Iowa Infant Feeding Attitude Scale which is used to assess mother?s attitudes and behaviours towards breastfeeding, distinguishes between those mothers who intended to breast-feed and those who intended to artificially feed.The IIFAS was \[34\] designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding. Total IIFAS scores can be further categorized into groups: 1) positive to breastfeeding (IIFAS score 70-85), 2) neutral (IIFAS score 49-69), and 3) positive to formula feeding (IIFAS score 17-48).

    First 6 months

Secondary Outcomes (3)

  • LATCH: a breastfeeding charting system and documentation tool

    First 6 months

  • Breast-feeding Self-efficacy Scale

    First 3 months

  • Information Assessment Form of Grandmothers for Breastfeeding (Pre-Test Post-Test Evaluation)

    First 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling. In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined. As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.

Other: The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling.

Control Group

NO INTERVENTION

Control Group: No additional attempt or routine call will be made to grandmother and mothers in the control group. The questionnaires will be given to the mothers at the same time for filling the surveys after birth, one month, 3 and 6 months follow up will be done with grandmothers and mothers.

Interventions

The research was planned as a randomized controlled study. Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group. The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling. In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined. As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Being a newly born primipara mother
  • No complications developed in mother and baby after birth
  • Having the grandmother for caring the baby
  • The grandmother's role in baby care with the family after discharge
  • At least primary school graduate for mother and grandmother
  • Speak Turkish
  • Volunteering to participate in further follow-up or research

You may not qualify if:

  • Not willing to participate in the study
  • Not actively participate in all training
  • Not willing to fill in the questionnaire
  • Having mental and psychological diseases
  • Illiterate mothers and grandmothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Nursing Faculty

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Özlem Demirel Bozkurt, Ass.Prof

    Ege University Nursing Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruşen Öztürk, Dr.

CONTACT

Mehmet Yekta ÖNCEL

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, randomised, parallel trial design Masking: Single (Participant) Primary Purpose: Supportive Care
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was planned as a randomized controlled study. Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MSN, PhD (Principal Investigator)

Study Record Dates

First Submitted

March 20, 2021

First Posted

May 28, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

September 1, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

We don't want to share until published.

Locations