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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771324
• Other study ID #: nurten.arslan
• Secondary ID: 2020-19093093-02
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: March 2023
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Complementary Feeding
• Growth
• Infant Development
• Obesity, Infant
• Pediatric Obesity

Intervention

Other:
• Baby-Led Weaning (BLW)
BLW trainings given to mothers for 6-12 month old babies
• Traditional Complementary Feeding (TCF)
TCF trainings given to mothers for 6-12 month old babies

Locations

Country	Name	City	State
Turkey	ZonguldakBEU	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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 Pedia — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Effect on infant anemia and iron deficiency	Iron levels in infants were examined.	Examining the change at 12 months.
Primary	Effect on infant obesity risk	The 12-month BMI distributions of the groups were analyzed.	Examining the change at 12 months.
Secondary	Early transition to solid food	Solid food intake time in infants in both groups was evaluated as months	Examining the change at 12 months.
Secondary	Early transition to self feeding	Self feeding time in infants in both groups was evaluated as months	Examining the change at 12 months
Secondary	Early transition to family meals	Family meals time in infants in both groups was evaluated as months	Examining the change at 12 months.