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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant

Intervention / Treatment
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* Other: Baby-Led Weaning (BLW)
* Other: Traditional Complementary Feeding (TCF)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baby-Led Weaning (BLW)<br>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)<br>* BLW trainings given to mothers for 6-12 month old babies<br>* Other names: BLW;|
| Experimental: Traditional Complementary Feeding (TCF)<br>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)<br>* TCF trainings given to mothers for 6-12 month old babies<br>* Other names: TCF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on infant growth | 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 | 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 | Iron levels in infants were examined. | Examining the change at 12 months. | 
| Effect on infant obesity risk | 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 | Solid food intake time in infants in both groups was evaluated as months | Examining the change at 12 months. | 
| Early transition to self feeding | Self feeding time in infants in both groups was evaluated as months | Examining the change at 12 months | 
| Early transition to family meals | Family meals time in infants in both groups was evaluated as months | Examining the change at 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant, solid food