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NCT Number: NCT05771324

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

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.

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Key information

Conditions

Growth Anemia Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Body Weight Complementary Feeding Hematologic Diseases Hemic and Lymphatic Diseases Infant Development Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutrition, Healthy Nutritional and Metabolic Diseases Obesity Obesity, Infant Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

4 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZonguldakBEU

Zonguldak, +90(544) 382 67 16, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baby-Led Weaning (BLW)

Other

BLW trainings given to mothers for 6-12 month old babies

Other names: BLW

Traditional Complementary Feeding (TCF)

Other

TCF trainings given to mothers for 6-12 month old babies

Other names: TCF

Primary outcomes

  1. 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.

  2. 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.

  3. Effect on infant anemia and iron deficiency

    Time frame: Examining the change at 12 months.

    Iron levels in infants were examined.

  4. Effect on infant obesity risk

    Time frame: Examining the change at 12 months.

    The 12-month BMI distributions of the groups were analyzed.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 16, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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