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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05771324
Enrollment
62
Registered
2023-03-16
Start date
2021-01-18
Completion date
2022-04-18
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERBaby-Led Weaning (BLW)

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

OTHERTraditional Complementary Feeding (TCF)

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

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The participants who were assigned to the researcher groups that evaluated the hematological test results of the babies and followed the growth were kept confidential from the interventions. The person evaluating the outcomes was kept confidential from the participant and the interventions. Participants did not know about the other intervention group.

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.

Eligibility

Sex/Gender
ALL
Age
4 Months to 6 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect on infant growthExamining the change at 12 monthsBMI of babies were used as growth criteria. In addition, Z-score values for BMI were examined according to WHO standards.
Effect on infant developmenter parameterExamining the change at 12 monthsIn 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.
Effect on infant anemia and iron deficiencyExamining the change at 12 months.Iron levels in infants were examined.
Effect on infant obesity riskExamining the change at 12 months.The 12-month BMI distributions of the groups were analyzed.

Secondary

MeasureTime frameDescription
Early transition to self feedingExamining the change at 12 monthsSelf feeding time in infants in both groups was evaluated as months
Early transition to family mealsExamining the change at 12 months.Family meals time in infants in both groups was evaluated as months
Early transition to solid foodExamining the change at 12 months.Solid food intake time in infants in both groups was evaluated as months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026