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

NCT05771324 | Completed

• 2 other identifiers: nurten.arslan2020-19093093-02
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Early transition to solid food

  Examining the change at 12 months.

• Early transition to self feeding

  Examining the change at 12 months

• Early transition to family meals

  Examining the change at 12 months.

Study Arms (2)

Baby-Led Weaning (BLW)

EXPERIMENTAL

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)

Traditional Complementary Feeding (TCF)

EXPERIMENTAL

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)

Interventions

Baby-Led Weaning (BLW) OTHER

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

Also known as: BLW

Baby-Led Weaning (BLW)

Traditional Complementary Feeding (TCF) OTHER

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

Also known as: TCF

Traditional Complementary Feeding (TCF)

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

ZonguldakBEU

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

Location

Related Publications (17)

• Cameron SL, Taylor RW, Heath AL. Development and pilot testing of Baby-Led Introduction to SolidS--a version of Baby-Led Weaning modified to address concerns about iron deficiency, growth faltering and choking. BMC Pediatr. 2015 Aug 26;15:99. doi: 10.1186/s12887-015-0422-8.

  PMID: 26306667 BACKGROUND

• Cameron SL, Taylor RW, Heath AL. Parent-led or baby-led? Associations between complementary feeding practices and health-related behaviours in a survey of New Zealand families. BMJ Open. 2013 Dec 9;3(12):e003946. doi: 10.1136/bmjopen-2013-003946.

  PMID: 24327363 BACKGROUND

• Cameron SL, Heath AL, Taylor RW. How feasible is Baby-led Weaning as an approach to infant feeding? A review of the evidence. Nutrients. 2012 Nov 2;4(11):1575-609. doi: 10.3390/nu4111575.

  PMID: 23201835 BACKGROUND

• Daniels L, Taylor RW, Williams SM, Gibson RS, Fleming EA, Wheeler BJ, Taylor BJ, Haszard JJ, Heath AM. Impact of a modified version of baby-led weaning on iron intake and status: a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e019036. doi: 10.1136/bmjopen-2017-019036.

  PMID: 29950456 BACKGROUND

• Daniels L, Heath AL, Williams SM, Cameron SL, Fleming EA, Taylor BJ, Wheeler BJ, Gibson RS, Taylor RW. Baby-Led Introduction to SolidS (BLISS) study: a randomised controlled trial of a baby-led approach to complementary feeding. BMC Pediatr. 2015 Nov 12;15:179. doi: 10.1186/s12887-015-0491-8.

  PMID: 26563757 BACKGROUND

• Williams Erickson L, Taylor RW, Haszard JJ, Fleming EA, Daniels L, Morison BJ, Leong C, Fangupo LJ, Wheeler BJ, Taylor BJ, Te Morenga L, McLean RM, Heath AM. Impact of a Modified Version of Baby-Led Weaning on Infant Food and Nutrient Intakes: The BLISS Randomized Controlled Trial. Nutrients. 2018 Jun 7;10(6):740. doi: 10.3390/nu10060740.

  PMID: 29880769 BACKGROUND

• Morison BJ, Taylor RW, Haszard JJ, Schramm CJ, Williams Erickson L, Fangupo LJ, Fleming EA, Luciano A, Heath AL. How different are baby-led weaning and conventional complementary feeding? A cross-sectional study of infants aged 6-8 months. BMJ Open. 2016 May 6;6(5):e010665. doi: 10.1136/bmjopen-2015-010665.

  PMID: 27154478 BACKGROUND

• Robert RC, Creed-Kanashiro HM, Villasante R, Narro MR, Penny ME. Strengthening health services to deliver nutrition education to promote complementary feeding and healthy growth of infants and young children: formative research for a successful intervention in peri-urban Trujillo, Peru. Matern Child Nutr. 2017 Apr;13(2):e12264. doi: 10.1111/mcn.12264. Epub 2016 Mar 2.

  PMID: 26931182 BACKGROUND

• Taylor RW, Williams SM, Fangupo LJ, Wheeler BJ, Taylor BJ, Daniels L, Fleming EA, McArthur J, Morison B, Erickson LW, Davies RS, Bacchus S, Cameron SL, Heath AM. Effect of a Baby-Led Approach to Complementary Feeding on Infant Growth and Overweight: A Randomized Clinical Trial. JAMA Pediatr. 2017 Sep 1;171(9):838-846. doi: 10.1001/jamapediatrics.2017.1284.

  PMID: 28692728 BACKGROUND

• Brown A, Lee M. An exploration of experiences of mothers following a baby-led weaning style: developmental readiness for complementary foods. Matern Child Nutr. 2013 Apr;9(2):233-43. doi: 10.1111/j.1740-8709.2011.00360.x. Epub 2011 Nov 28.

  PMID: 22118242 BACKGROUND

• Sazawal S, Dhingra P, Dhingra U, Gupta S, Iyengar V, Menon VP, Sarkar A, Black RE. Compliance with home-based fortification strategies for delivery of iron and zinc: its effect on haematological and growth markers among 6-24 months old children in north India. J Health Popul Nutr. 2014 Jun;32(2):217-26.

  PMID: 25076659 BACKGROUND

• D'Auria E, Bergamini M, Staiano A, Banderali G, Pendezza E, Penagini F, Zuccotti GV, Peroni DG; Italian Society of Pediatrics. Baby-led weaning: what a systematic review of the literature adds on. Ital J Pediatr. 2018 May 3;44(1):49. doi: 10.1186/s13052-018-0487-8.

  PMID: 29724233 BACKGROUND

• ESPGHAN Committee on Nutrition; Agostoni C, Braegger C, Decsi T, Kolacek S, Koletzko B, Michaelsen KF, Mihatsch W, Moreno LA, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J. Breast-feeding: A commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2009 Jul;49(1):112-25. doi: 10.1097/MPG.0b013e31819f1e05.

  PMID: 19502997 RESULT

• Alvisi P, Brusa S, Alboresi S, Amarri S, Bottau P, Cavagni G, Corradini B, Landi L, Loroni L, Marani M, Osti IM, Povesi-Dascola C, Caffarelli C, Valeriani L, Agostoni C. Recommendations on complementary feeding for healthy, full-term infants. Ital J Pediatr. 2015 Apr 28;41:36. doi: 10.1186/s13052-015-0143-5.

  PMID: 25928205 RESULT

• Brown A, Jones SW, Rowan H. Baby-Led Weaning: The Evidence to Date. Curr Nutr Rep. 2017;6(2):148-156. doi: 10.1007/s13668-017-0201-2. Epub 2017 Apr 29.

  PMID: 28596930 RESULT

• Brown A. No difference in self-reported frequency of choking between infants introduced to solid foods using a baby-led weaning or traditional spoon-feeding approach. J Hum Nutr Diet. 2018 Aug;31(4):496-504. doi: 10.1111/jhn.12528. Epub 2017 Dec 5.

  PMID: 29205569 RESULT

• Arslan N, Kurtuncu M, Turhan PM. The effect of baby-led weaning and traditional complementary feeding trainings on baby development. J Pediatr Nurs. 2023 Nov-Dec;73:196-203. doi: 10.1016/j.pedn.2023.09.006. Epub 2023 Sep 13.

  PMID: 37714048 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Pediatric Obesity

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• NURTEN ARSLAN

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: March 16, 2023
• Study Start: January 18, 2021
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data can be shared immediately after summary data is published.
• Access Criteria: The data were shared with the statistician for analysis.

Locations

TU (1)