The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development

March 4, 2023 updated by: Nurten ARSLAN, Zonguldak Bulent Ecevit University

The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development Randomized Controlled Trial

The goal of this [type of study: clinical trial] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the BLW method and TCF method given to the mothers of infants who have switched to complementary feeding. The main question[s] it aims to answer are:

  • Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the feeding and development of the babies in both groups?
  • Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the obesity risk and anemia risk of babies in both groups?

Participants will participate in each session of the complementary nutrition trainings given in accordance with their age on a monthly basis and will provide a diet suitable for the trainings.

Researchers will compare the nutritional parameters, developmental levels, and height and weight gains of infants fed with the BLW and TCF method to see the effect of complementary feeding education on the nutrition and development of infants and whether there is anemia and obesity risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Regarding the basic questions that the study aims to answer;

Micronutrient intake, hemoglobin, ferritin and vitamin B12 levels were evaluated to examine the effects of the trainings on infant nutrition.

Physical, cognitive, psychosocial, language, motor and game development levels of infants were evaluated in order to examine the effects of training on infant development.

Weight gain, WLZ, LAZ and WAZ scores of infants were evaluated to examine the effects of the education given on obesity risk.

Hemoglobin, hematocrit and ferritin levels were evaluated to examine the effects of the training given on the risk of anemia.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Zonguldak, Turkey, +90(544) 382 67 16
        • ZonguldakBEU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

for mothers;

  • The fact that the mothers came to the center where the research will be conducted for routine baby follow-up and vaccination follow-up.
  • Mothers' willingness to participate in the research
  • Absence of any communication problems
  • The mothers must be at least 19 years old.
  • Mothers have no physical or mental disability

for babies;

. Babies must be at least 4 months and maximum 6 months old when they are included in the study.

  • Complementary feeding not yet started
  • Babies being fed only with breast milk
  • Babies not born before 38 weeks of gestation
  • Absence of a congenital anomaly
  • Absence of any digestive and neurological system diseases that may affect nutrition

Exclusion Criteria:

  • Infants and mothers who did not meet the inclusion criteria were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baby-Led Weaning (BLW)
The group named for infants who received complementary feeding education with the BLW method and who were fed with the BLW method.
Other: Baby-Led Weaning (BLW)
BLW trainings given to mothers for 6-12 month old babies
Other Names:
  • BLW
Experimental: Traditional Complementary Feeding (TCF)
The group named for infants who received complementary nutrition education with the TCF method and who were fed with the TCF method.
Other: Traditional Complementary Feeding (TCF)
TCF trainings given to mothers for 6-12 month old babies
Other Names:
  • TCF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on infant growth
Time Frame: Examining the change at 12 months
BMI of babies were used as growth criteria. In addition, Z-score values for BMI were examined according to WHO standards.
Examining the change at 12 months
Effect on infant developmenter parameter
Time Frame: Examining the change at 12 months
In the evaluation of infant development, motor developmental evaluation criteria used as standard in the national infant follow-ups of the T.C. Ministry of Health were used.
Examining the change at 12 months
Effect on infant anemia and iron deficiency
Time Frame: Examining the change at 12 months.
Iron levels in infants were examined.
Examining the change at 12 months.
Effect on infant obesity risk
Time Frame: Examining the change at 12 months.
The 12-month BMI distributions of the groups were analyzed.
Examining the change at 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early transition to solid food
Time Frame: Examining the change at 12 months.
Solid food intake time in infants in both groups was evaluated as months
Examining the change at 12 months.
Early transition to self feeding
Time Frame: Examining the change at 12 months
Self feeding time in infants in both groups was evaluated as months
Examining the change at 12 months
Early transition to family meals
Time Frame: Examining the change at 12 months.
Family meals time in infants in both groups was evaluated as months
Examining the change at 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Investigators

  • Principal Investigator: NURTEN ARSLAN, Zonguldak Bülent Ecevit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Actual)

April 18, 2021

Study Completion (Actual)

April 18, 2022

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

March 4, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nurten.arslan
  • 2020-19093093-02 (Other Grant/Funding Number: Zonguldak Bulent Ecevit University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The researcher who made the evaluation did not have information about the experimental groups and which group the individuals were assigned to.

IPD Sharing Time Frame

Data can be shared immediately after summary data is published.

IPD Sharing Access Criteria

The data were shared with the statistician for analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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