search
Back to results

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

Primary Purpose

Growth, Infant Development, Complementary Feeding

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby-Led Weaning (BLW)
Traditional Complementary Feeding (TCF)
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Growth focused on measuring Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant, solid food

Eligibility Criteria

4 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ZonguldakBEU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Baby-Led Weaning (BLW)

Traditional Complementary Feeding (TCF)

Arm Description

The group named for infants who received complementary feeding education with the BLW method and who were fed with the BLW method.

The group named for infants who received complementary nutrition education with the TCF method and who were fed with the TCF method.

Outcomes

Primary Outcome Measures

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.
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.
Effect on infant anemia and iron deficiency
Iron levels in infants were examined.
Effect on infant obesity risk
The 12-month BMI distributions of the groups were analyzed.

Secondary Outcome Measures

Early transition to solid food
Solid food intake time in infants in both groups was evaluated as months
Early transition to self feeding
Self feeding time in infants in both groups was evaluated as months
Early transition to family meals
Family meals time in infants in both groups was evaluated as months

Full Information

First Posted
February 5, 2023
Last Updated
March 4, 2023
Sponsor
Zonguldak Bulent Ecevit University
search

1. Study Identification

Unique Protocol Identification Number
NCT05771324
Brief Title
The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development
Official Title
The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
April 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baby-Led Weaning (BLW)
Arm Type
Experimental
Arm Description
The group named for infants who received complementary feeding education with the BLW method and who were fed with the BLW method.
Arm Title
Traditional Complementary Feeding (TCF)
Arm Type
Experimental
Arm Description
The group named for infants who received complementary nutrition education with the TCF method and who were fed with the TCF method.
Intervention Type
Other
Intervention Name(s)
Baby-Led Weaning (BLW)
Other Intervention Name(s)
BLW
Intervention Description
BLW trainings given to mothers for 6-12 month old babies
Intervention Type
Other
Intervention Name(s)
Traditional Complementary Feeding (TCF)
Other Intervention Name(s)
TCF
Intervention Description
TCF trainings given to mothers for 6-12 month old babies
Primary Outcome Measure Information:
Title
Effect on infant growth
Description
BMI of babies were used as growth criteria. In addition, Z-score values for BMI were examined according to WHO standards.
Time Frame
Examining the change at 12 months
Title
Effect on infant developmenter parameter
Description
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.
Time Frame
Examining the change at 12 months
Title
Effect on infant anemia and iron deficiency
Description
Iron levels in infants were examined.
Time Frame
Examining the change at 12 months.
Title
Effect on infant obesity risk
Description
The 12-month BMI distributions of the groups were analyzed.
Time Frame
Examining the change at 12 months.
Secondary Outcome Measure Information:
Title
Early transition to solid food
Description
Solid food intake time in infants in both groups was evaluated as months
Time Frame
Examining the change at 12 months.
Title
Early transition to self feeding
Description
Self feeding time in infants in both groups was evaluated as months
Time Frame
Examining the change at 12 months
Title
Early transition to family meals
Description
Family meals time in infants in both groups was evaluated as months
Time Frame
Examining the change at 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NURTEN ARSLAN
Organizational Affiliation
Zonguldak Bulent Ecevit University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZonguldakBEU
City
Zonguldak
ZIP/Postal Code
+90(544) 382 67 16
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The researcher who made the evaluation did not have information about the experimental groups and which group the individuals were assigned to.
IPD Sharing Time Frame
Data can be shared immediately after summary data is published.
IPD Sharing Access Criteria
The data were shared with the statistician for analysis.
Citations:
PubMed Identifier
26306667
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.
Results Reference
background
PubMed Identifier
24327363
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.
Results Reference
background
PubMed Identifier
23201835
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.
Results Reference
background
PubMed Identifier
29950456
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.
Results Reference
background
PubMed Identifier
26563757
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.
Results Reference
background
PubMed Identifier
29880769
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.
Results Reference
background
PubMed Identifier
27154478
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.
Results Reference
background
PubMed Identifier
26931182
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.
Results Reference
background
PubMed Identifier
28692728
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.
Results Reference
background
PubMed Identifier
22118242
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.
Results Reference
background
PubMed Identifier
25076659
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.
Results Reference
background
PubMed Identifier
29724233
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.
Results Reference
background
PubMed Identifier
19502997
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 Pediatr Gastroenterol Nutr. 2009 Jul;49(1):112-25. doi: 10.1097/MPG.0b013e31819f1e05.
Results Reference
result
PubMed Identifier
25928205
Citation
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.
Results Reference
result
PubMed Identifier
28596930
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.
Results Reference
result
PubMed Identifier
29205569
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs