Clinical trial NCT05771324: The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development
Official title: The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Infant Development
Complementary Feeding
Nutrition, Healthy
Anemia, Iron Deficiency
Obesity, Infant
Keywords: Growth
Infant Development
Complementary Feeding
Nutrition, Healthy
Anemia, Iron Deficiency
Obesity, Infant
solid food
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size of the study consisted of 62 people according to the power analysis. Block and stratified randomization methods were used in the selection of the experimental groups. When the literature is examined, there are studies showing the effect of mothers' education level and previous complementary food experiences on the transition to solid food. Accordingly, stratification was made according to the education level of the mothers and the number of children. Thus, two people were assigned homogeneously in each block according to the education level of the mothers and the number of children. Randomization was done by the Outcome Evaluator independently of the investigators. The research was carried out according to the Consort 2010 Flow Chart and the study was concluded with 56 people.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect on infant growth
timeFrame: Examining the change at 12 months
measure: Effect on infant developmenter parameter
timeFrame: Examining the change at 12 months
measure: Effect on infant anemia and iron deficiency
timeFrame: Examining the change at 12 months.
measure: Effect on infant obesity risk
timeFrame: Examining the change at 12 months.
Secondary outcomes:
measure: Early transition to solid food
timeFrame: Examining the change at 12 months.
measure: Early transition to self feeding
timeFrame: Examining the change at 12 months
measure: Early transition to family meals
timeFrame: Examining the change at 12 months.
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: ZonguldakBEU
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: NURTEN ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
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