PROF.

GONCA YILMAZ (Orcid ID : 0000-0003-2242-5416)

Accepted Article
DR. NILGUN CAYLAN (Orcid ID : 0000-0003-4239-3423)

Article type : Original Articles

Original article

Baby-led complementary feeding: a randomized

controlled study

Erkan Dogan1, Gonca Yilmaz2, Nilgun Caylan3, Mahmut Turgut4,

Gulbin Gokcay 5, Melahat Melek Oguz6
1
: Associate of Professor of Pediatrics, Karabuk University of Medicine, Pediatrics
Department, Karabuk, Turkey.

2
: Professor of Pediatrics, Social Pediatrics Department, Karabuk University of Medicine,
Pediatrics Department, Karabuk, Turkey

3
: Pediatric specialist, Public Health Agency of Turkey, Child and Adolescent Health
Department, Ankara, Turkey.

4
: Pediatric specialist, Karabuk University of Medicine, Pediatrics Department, Karabuk,
Turkey.

5
: Professor of Pediatrics, Istanbul University Institute of Child Health Department of
Social Pediatrics, İstanbul, Turkey.

This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/ped.13671
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 6
: Pediatric specialist, Dr. Sami Ulus Children Training Hospital, Ankara, Turkey.

Disclosure
Accepted Article
The authors declare no conflict of interest.

Correspondence address: Gonca Yilmaz, MD, PhD

Karabuk University Faculty of Medicine

Department of Pediatrics, 06100 Karabuk, Turkey

Phone: 90-5353040322

E-mail: goncay31@gmail.com

15 text pages, 3838 words, 5 reference pages, 4 tables, 1 figure and legend to figure.

Baby-led complementary feeding: a randomized controlled study

Abstract

Background: Baby-led weaning (BLW) is an approach to introducing solid foods to infants which

gives control of the feeding process to the infant. Anecdotal evidence suggests that BLW is becoming

popular with parents, but scientific research is limited to a few publications. This study assessed

growth, hematological parameters and iron intakes among 6-12 month-old infants who were fed by

traditional or baby-led complementary feeding.

Methods: We recruited 280 healthy 5-6 month old infants allocated to control (traditional spoon

feeding) (TSF) group or intervention of Baby-Led Weaning (BLW) group in a randomized controlled

trial. İnfants’ growth, hematologic parameters and iron intakes were evaluated at age 12 months.

Results: Infants in the TSF were significantly currently heavier than those in the BLW group. Mean

weight in kilogram of infants in the BLW group was 10.4 ± 0.9 compared with 11.1 ± 0.5 in the TSF

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 group. There was no statistically significant difference in the iron intakes from complementary foods

by the BLW (7.97 ± 1.37 mg/day) and TSF group (7.90 ± 1.68 mg/day) participants who completed
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the diet records. Hematologic parameters were similar at 12 months. The incidence of choking

reported in the weekly interviews was not different between the groups.

Conclusions: To the best of our knowledge, this is the first randomized-controlled study to have

examined the impact of weaning method on iron intakes, hematological parameters and growth in

breastfed infants. BLW can be an alternative complementary feeding type without increasing the risk

of iron deficiency, choking and growth faltering.

Key words: Baby-led feeding, complementary feeding, infant weight, iron intake, choking.

INTRODUCTION

Introduction of complementary feeding is an important period in the growth and

development of a child, both for the family and the infant itself, and it can play a major role in a

child’s future health. According to World Health Organization (WHO) recommendations on infant

and young child feeding, current advice is to introduce complementary foods from 6 months of

age1,2 In a recent complementary feeding approach, baby-led weaning (BLW), foods in their whole

form are presented to the baby, who self-selects, grasps, brings to the mouth and consumes of its

own volition. 2-4 One of most important characteristic of BLW is that maternal control overfeeding is

minimal such that the infant decides which food item is selected, how much of it is consumed and

the speed of consumption throughout an eating episode.3 Obesity among Turkish people and

children is an emerging issue. BLW may be important feeding method for preventing obesity rates in

our country.5

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 Although a number of potential advantages of BLW have been proposed, including: a lower

risk of obesity, as a result of better energy self-regulation; better diet quality; favorable effects on
Accepted Article
parental feeding practices; and more highly developed motor skills, several concerns have also been

raised about this alternative approach to complementary feeding could increase the risk of iron

deficiency, choking and growth faltering in infants.6-9 However, the impact of baby-led weaning on

health-related outcomes was not studied adequately.

The aim of our study is to determine whether BLW can be an alternative complementary

feeding type without increasing the risk of iron deficiency, choking and growth faltering. The primary

objective of this study is to determine how BLW group weight, length and head circumference

change from traditional (control) group anthropometric measures at 12 months of age. We also

assessed iron intakes and iron blood status of two groups at 12 months.

PATIENTS AND METHODS

Study design

Families with a child aged five to six months were recruited from our well-child clinic for a

randomized prospective trial. Accordingly, eligible mothers were randomly assigned to control

(traditional spoon feeding) (TSF) or intervention (Baby led-feeding) (BLW) groups with random

length blocks. Research staff defined by opening the next consecutive opaque, pre-sealed envelope

in the stratum to which the participant belongs and informed the participant which group they have

been assigned to.

All outcome data were collected by research staff blinded to group allocation. The study

consisted of a 6-month intervention phase with the main outcomes at 12 months of age.

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 The study was approved by Karabuk University Ethic Committee and written inform consent

was obtained from a parent or parents of eligible infants before enrollment.

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Participants

Two hundred eighty infants (138 boys and 142 girls) between 5-6 months of age from

Karabük University Well Child Clinic were enrolled and completed study between January 2014 and

April 2016. One thousand five hundred twenty-two families who had a child aged 5 months and who

were intending to introduce complementary foods to their infant were examined for eligibility in our

well child clinic between February 2014- November 2015. 1220 families were excluded from the

study before consent was obtained. 302 participants gave consent and randomized and allocated to

two groups (n=146 TSF, n=156 BLW) for 6-month follow-up. During study, 14 participants from BLW

group, 8 participants from TSF group lost follow-up. The final number of participants who assessed

for study were 280 (BLW n=142, TSF N=138) (Figure 1).

Exclusion criteria

To be eligible for inclusion in the study, the following criteria had to be met: (1) infants had

to have a gestational age between 38 and 42 weeks; (ii) the birthweight had to be >2500 g; (2) it had

to have been a singleton pregnancy; (3) no illness in the preceding 1 month before enrollment into

the study; (4) head circumference, height and weight within ± 2SD of mean values for chronological

age according to World Health Organization (WHO) growth charts 10; (5) no congenital anomalies or

chronic conditions that would affect feeding, growth and developmental potential (6) no history of

iron supplementation or therapy; (8) Infants with hemoglobin (Hb) >11 g/dL, serum ferritin levels

higher than 10 µg/L and transferrin saturation (TS=serum iron`100/iron-binding capacity) >10% and

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 (7) if mothers had not current or planned formula use (if mothers could show an intent or history of

exclusive breastfeeding (no formula use) through 1 year.

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Study groups

All families received free well-child care visits at birth, 2 weeks, 2, 4, 6, 9, 12 months. All

mothers were recommended to continue breastfeeding and give complementary foods according to

the WHO Guidelines.1 Exclusive breastfeeding indicated that the infant did not take any

supplementary food, not even water. We also educated all parents on food choices for their children

with iron rich and iron fortified foods.

BLW (Intervention) group

Participants in the BLW group received 4 additional group contact and 6 home visits for

supporting and education of this type of complementary feeding. when the infant was 5.5, 6,5, 7, 8,

9 and 11 months of age. Trained research staff supervised by a multidisciplinary team (dietitian,

pediatrician, lactation consultant, pediatric nurse) gave a range of recipe books and food lists to

Baby-led participants explaining how to follow Baby-led approach and provided information about

the study, age-appropriate family recipes, food lists and safety information . 6,7

We used a modified form of BLW to address the primary concerns (choking, increased risk of

low iron status, increased risk of growth faltering) of health care professsionals and parents (BLISS,

Baby Led introduction to solids). 6,7

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 Foods thought to pose a choking risk were identified using lists from the literature and any

foods that were deemed to present a high risk of choking were excluded.
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The high-iron recipes included red meat, liver, iron fortified infant cereal, or legumes, and

contained an average of 2.3 mg of iron per 100 g. BLW mothers were allowed to feed their infants

less than 10 % spoon-feeding and 10 % purees.

BLW parents were encouraged to offer a variety of foods, including at least one high-energy

food at each meal and were provided with food ideas and recipes that were high in energy and could

be easily self-fed by the infant. 1,6,7

Control (traditional) feeding group

Participants in TSF (control) group were not given any feeding protocol to follow and

received standard well child care from the providers of their choice.

Data Collection

Demographic variables collected at baseline included infant sex, birth weights, gestational

age, maternal age, maternal education, maternal pre-pregnancy body mass index (BMI), parity,

working status, maternal leave period (week), family income, when complementary foods were

introduced (week).

All participants were asked to complete a structured 30 min telephone interview weekly

(‘weekly interview’) from 6 to 12 months of age. The data collected during the weekly interviews

were used to determine: a) adherence to a baby-led approach to complementary feeding; b) the

number of different (i.e., variety) of iron containing foods, high-energy foods, and high-choking-risk

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 foods that had been offered; c) whether gagging or choking had occurred and which foods were

responsible.
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Data on the iron content of the complementary foods offered were collected in two ways: all

participants completed the weekly interview and parents whose child was aged 12 months agreed to

complete a 24-h iron questionnaire on three non-consecutive days (‘3-day iron questionnaire’).

Measurements

Anthropometric measurements

Infants’ anthropometric measurements included three indices: weight, length, and head

circumference.

Infants were weighed at 6 and 12 months at the same time using a Seca 727 digital scale.

(Seca, Hamburg, Germany). All infant participants wore a standard nappy of known weight which is

provided to the parent and a singlet top. The weight of both items of clothing will be subtracted

from the reported body weight before analysis. Body weight will be measured and recorded to the

nearest 0.1 kg using digital scales. Birth weights were recorded from hospital data.

Infants were measured for crown-heel length at 6 and 12 months by Seca 416 infantometer

to the nearest 0.1 cm (Seca, Hamburg, Germany). İnfants head circumference were measured at 6

and12 months.

Body weight and length measurements were taken in duplicate and if the second

measurement differs by more than 0.1 kg for weight and 0.7 cm for length, a third measure will be

taken. An average of the measures was recorded (where there are three measurements taken, the

two closest will be averaged; where the three measures are equidistant the median value were

used).

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 We calculated: weight for length percentiles at 12 months of age, using the WHO child

growth standards. 11
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Iron intake and hematological measurements

Daily iron intake of infants by their diet was calculated as its ratio to the recommended daily

allowance (11mg /day) for 12 months of age. The amount of breast milk ingested by the infant was

roughly measured according to ALSPAC references.12 According to these references breast milk

amount taken for each minute of breastfeeding was calculated as 10ml. A feed lasting 10min or

longer was assumed to be 100ml in volume. Diet lists were evaluated with the Nutrition Information

System (BeBis) Program (Epispro for Windows, Stuttgart, Germany: Turkish version BeBis, Version 8,

Data bases. Bundeslebensmittelschlüssel, 11.3, USDA_ sr19 and other sources). The Turkish

Database updated in 2006 was used. After the diet records had been entered in program, a

registered dietitian blinded to the BLW or TSF status of the infant checked each diet record, and

made corrections when required.

Hb, hematocrit, mean corpuscular volume (MCV) and red cell distribution width (RDW) were

determined by a Coulter Counter-S model (Coulter®; STKS, Coulter Corp., Hialeah, FL, USA), serum

iron and iron-binding capacity were determined by colorimetric methods (Boehringer Mannheim/

Hitachi 704/911 1553704; Meylan, France) at 6 and 12 months of age. Serum ferritin was

determined by a modular analytic E 170 device, using the electro-chemiluminescence immunoassay

method at 6 and 12 months. The coefficient of variation (CV) of the measurements was always

below 5%. The control samples were within the manufacturer’s reference ranges.

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 Statistical analysis

SPSS 16.0 was utilized for statistical analysis. The significance was taken as p<0.05. Student’s
Accepted Article
t-test for independent samples was used to compare the means of continuous variables. Chi-square

test was used to compare the frequencies of interrupted variables. Linear regression was used to

determine independent factors influencing weight at 12 months of age; forward was chosen as a

method.

Results

The mean (SD) age of the participants was 30.2 (2.7) years. 16.4 % of the mothers had a

university degree, 48.9 % were primiparous mothers, and 51.4 % were in paid employment. Mean

income of the families was 4100 TL (4100/3.7=1108 USD).

There were no significant differences between the groups for these demographic variables

(maternal age p=0.961; maternal education p=0.90; parity p=0.98, maternal employment status

p=0.75; maternal leave period p=0.91, family income p=0.50 and maternal pre-pregnancy BMI (Body

Mass Index) p=0.50. (Table 1)

There was significant difference in exclusive breastfeeding duration between the two

weaning groups (BLW 24.4 ±1.3 weeks and TSF 23.6 ±1.0 weeks, P< 0.001). Women from the BLW

group exclusively breast fed their infants and introduced solid foods for ∼1 weeks later than women

following TSF (p< 0.001). (Table 1)

At enrollment, there were no significant differences in birthweight, anthropometric

measurements between the control and intervention groups (Table 1). Current child weight was

examined and compared for the two weaning groups at 12 months of age. Mean weight in kilogram

of infants in the BLW group was 10.4 ± 0.9 compared with 11.1 ± 0.5 in the TSF group. Infants in the

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 traditional group were significantly currently heavier than those in the BLW group (t = 8.45, P =

<0.001) (Table 2).

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Linear regression with the weight at 12 months of age as a dependent variable revealed

complementary feeding type as statistically significant independent factor (B=0.745, t=9.53, p<0.001,

95 % confidence interval for B=0.592-0.899). Birth weight and exclusive breastfeeding duration were

not statistically significant independent factors (p>0.05).

According to weight for length z scores: BLW group, 98 % were normal weight, 2 % were

underweight according to WHO child growth standards (WHO have suggested a set of cut-offs based

on single SD spacing. Thinness: less than -2SD, overweight: between +1SD and less than +2SD, obese:

more than +2SD).11 In comparison, 83 % of those in the TSF group were normal weight and 17% were

overweight. A greater percentage of those infants who were overweight followed TSF approach

(Table 4).

No significant differences were observed in Hb, Hematocrit, MCV, RDW, TS, and ferritin

levels between the intervention and control groups at study entry and after 6 months of

intervention (Table 3). According to diet records, iron intake by diet at 12 months of age was similar

in the BLW group and TSF group. Iron intakes from complementary foods by the BLW were (7.97 ±

1.37 mg/day) and TSF group (7.90 ± 1.68 mg/day) participants who completed the diet records

(Table 3).

The incidence of choking reported in the weekly interviews was not different between the

groups: BLW n=2, traditional feeding group n=3. The foods that had caused the incident were raw

apple (n = 2) and raw carrot (n = 3). All choking incidents were dealt with at home and did not

require medical intervention.

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 Discussion

Baby-Led Weaning (BLW) is an alternative method for introducing complementary

Accepted Article
foods to infants. By 6– 7 months of age, most infants are able to chew, sit unsupported and bring

foods to their mouth, suggesting that a gradual transition from purees to finger foods may now not

be necessary. 6,13,14

In our study, BLW group mothers were more likely to breastfeed their infants exclusively to 6

months, and waited until 6 months to introduce solids. In fact, following a Baby-Led approach to

weaning has also been identified as the strongest predictor of weaning (introduction of

complementary foods) at the recommended age.15-17

Our randomized controlled trial showed BLW itself was responsible for differences in body

weight, or energy self-regulation. According to our results, although there were no significant

differences in anthropometric measurements between the control and intervention groups at

enrollment, traditional feeding group gained more weight than intervention group at 12 months of

age. A greater percentage of those infants who were overweight followed TSF approach (17%).

When complementary foods are introduced using the TSF approach, the parent has much more

control and is likely to encourage the child to eat until they have consumed an amount of food that
18
the parent, rather than the child, considers is “enough” . A study showed that infants who had

followed BLW were reported by their parent to be significantly more satiety-responsive (able to

regulate intake of food in relation to satiety) and significantly less food-responsive (eating in

response to food stimuli regardless of hunger), than their traditionally-fed peers.19 Both

breastfeeding and BLW place the infant in control of intake and may support the responsiveness to

internal hunger and satiety cues, leading to better energy self-regulation. There is increasing

evidence that better energy self-regulation is associated with a lower risk of obesity.20

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 Randomized–controlled selection method is important because parents who follow BLW

have been shown to differ from parents following traditional methods of complementary feeding in
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demographic, psychological and parenting characteristics known to also be associated with body

weight.3,21 Two cross-sectional studies have investigated rates of obesity in infants following

BLW.17,19 Brown and Lee reported that toddlers who had followed BLW had significantly lower mean

body weight (by 1.07 kg), than those who had followed a traditional ‘parent-led’ spoon feeding

approach. But their sample was self-selecting both in terms of participation and decision to follow a

certain approach to weaning and relied on self-report of child weight.19 Townsend and Pitchford

found significantly lower Body Mass Index (BMI) and incidence of obesity in children at 20–78

months who had followed BLW compared to those who had been spoon-fed and increased

incidence of underweight in baby-led infants.17 They used different methods to recruit the BLW and

spoon-fed participants and standardized procedures for measuring body weight were only used in

the TSF group, making their results difficult to interpret. It is not possible to conclude from these

cross-sectional studies if there would be a relation between BLW and body weight. However, a

recent study using modified BLW showed baby-led approach to complementary feeding did not

result in more appropriate BMI than TSF. They mentioned that further research should determine

whether these findings apply to individuals using unmodified baby-led weaning. 22

There is a concern about a 6-month-old infant following BLW could eat enough to keep pace

with growth when self-feeding, based on the assumption that not all infants will have the motor

skills, or motivation, to feed themselves the amount of food they require, and that many of the first

foods offered will be low in energy.13 Although we did not assess the energy density of the foods

offered, only 2% of infants from BLW group was underweight (considering the physique of these

infants at baseline.) according to WHO growth charts.10,11 Furthermore, Morrison and Taylor, in their

small sample study, reported energy intakes were similar for the both BLW and traditional feeding

styles.16 In contrast to low energy purees which are frequently made of fruits or vegetables; finger

foods, if carefully chosen, can be very nutrient dense, so an infant who appears to be eating little

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 when self-feeding may potentially be closer to meeting their nutrient requirements. In our study,

mothers’ education about high energy complementary foods might have prevented growth faltering
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of their infants.4,5

In our study, we examined iron intake or iron status of children following a baby-led or

traditional approach to complementary feeding. There was no statistically significant difference

between the iron intakes from complementary foods by the BLW (7.97 ± 1.37 mg/day) and TSF

group (7.90 ± 1.68 mg/day) participants who completed the diet records. It was interesting that

none of our infants for whom diet record data were available were achieving the WHO

recommendation for iron intake from complementary foods of 10.8 mg/day (assuming medium

bioavailability and average breast milk intake).2 However, iron and hematologic parameters were

similar in both groups at 12 months of age and there wasn’t any anemic infant in either group. We

recommended all parents to offer developmentally appropriate iron-rich foods from the start of the

complementary feeding period, particularly if this occurs at the recommended 6 months of age.23-
25,26
One previous study showed infants following BLW had lower intakes of iron. But It is important

to note when interpreting their dietary data that their study was small, cross-sectional and not from

a random sample of families. And also in this study, majority of infants following traditional feeding

were consuming formula.16 As a result, pediatricians should emphasize the importance of including

iron-rich food sources in infants’ diets in the complementary feeding period because of the well-

accepted challenges of achieving adequate iron intake at this age, whether BLW or TSF is being

followed.27-30

According to parental reports there was no difference between two groups for choking (BLW

n=2, traditional feeding group n=3). The foods that had caused the incident were raw apple (n = 2)

and raw carrot (n = 3). Although we specifically advised against these foods in our study, families

offered these foods posing choking risk. 31

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 In Cameron’s study, mothers considered BLW to be a healthier, more convenient and less

stressful way to introduce complementary foods to their infant and did not report being concerned
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about choking. However, 30% of mothers reported at least one choking episode, most commonly

with raw apple.9 In another study, which included specific advice to minimize the risk of food-related

choking, BLW did not appear to result in more choking events in the first year of life than were

observed in the TSF group .32

The strengths of this study were as follows:

1) the study was a randomized controlled trial in contrast to most research available for the

complementary feeding period; prospective nature, and the weekly follow-up, which reduced the

risk of recall bias and increased adherence.

2) Sample size is large if we compare with other randomized controlled studies.

3) We measured iron status, iron intakes and growth, which are the ultimate indicators of the

adequacy of iron and energy intakes.

One limitation of our study was the infants’ actual nutrient and energy intakes were not

determined. Although mothers reported that a wide range of family foods were offered to the

infants, their energy intake could not be assessed. In addition, because only breastfed infants were

studied, it was not clear whether formula-fed infants would have followed a different growth

pattern when exposed to the same complementary feeding regimens.

To the best of our knowledge, this is the first study to have examined the impact of weaning

method on health outcomes in early childhood. BLW can be an alternative complementary feeding

type without increasing the risk of iron deficiency, choking and growth faltering. Future research

should determine whether our findings hold for more specific populations, such as babies born

prematurely with specific health difficulties. In addition, findings from this study require additional

confirmation for formula fed infants.

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 Disclosure

The authors declare no conflict of interest.

Accepted Article
Author contributions

E. D. and G. Y. designed the study; M. T., M. O. and G. Y. carried out patient management and

organized and reported data; N. C., E. D. and G.G. analyzed and interpreted the results; and G.Y.

wrote the manuscript. All authors read and approved the final manuscript.

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 Table 1: Comparison of various parameters of traditional-fed and baby-led groups at 6 months of
age

(Chi-square test and Student’s t-test for independent samples).

Accepted Article
Parameter Baby-led Traditional-fed Statistics P-value

n=138 n=142

Mean ± SD or n (%) Mean ± SD or n

(%)

Sex

Female 70 (51) 72 (51) Χ2= 0.000 0.997

Male 68 (49) 70 (49)

Gestational age (week) 38.81 ± 0.60 38.71 ± 0.59 t=0.83 0.41

Birth weight (kg) 3.3± 0.1 3.3 ± 0.1 t=1.53 0.13

Maternal age

<20 5 (4) 6 (4) Χ2=0.079 0.961

20-34 74 (54) 70 (49)

≥35 59 (42) 66 (47)

Maternal education

Primary 38 (27,5) 36 (25) Χ2= 0.21 0.90

High school 44 (32) 48 (34)

University 56 (40.5) 58 (41)

Parity

Primiparous 68 (49) 69 (49) Χ2=0.022 0.98

Multiparous 70 (51) 73 (51)

Parent Body mass index 24.42  2.1 23.9  2.4 t=0.68 0.50

Employment

Unemployed 68 (49) 69 (49) Χ2=0.57 0.75

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 Employed 70 (51) 73 (51)
Accepted Article
Maternal Leave Period (weeks) 11.42 ± 5.15 10.33 ± 4.11 t=0.11 0.91

Income (TL)

 2000 26 (19) 22 (15) Χ2=1.38 0.50

2000-4000 50 (36) 48 (34)

>4000 62 (45) 72 (51)

Infant’s length at 6 months 68.4 ± 2 67.7 ± 1.9 t=0.68 0.50

Infant’s head circumference 43.3 ± 0.6 43.9 ± 0.8 t=0.12 0.91

Infant’s weight at 6 months (kg) 7.9 ± 0.4 7.8± 0.4 t=0.84 0.40

Exclusive breastfeeding (weeks) 24.4± 1.3 23.6 ± 1.0 t=6.1 P <0.001

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 Table 2: Comparison of length, weight and head circumference of 12-month-old infants according to
feding method (Student’s t-test for independent samples).
Accepted Article
Parameter Baby-led Traditional- Statistics P- value
fed

n=142
n=138
Mean ± SD
Mean ± SD

Length increment between 6 to 12 months of age 9.8 ± 1.9 9.7 ± 1.7 t=0.30 0.73

Head circumference increment between 6 to 12 3 ± 0.7 3.1 ± 0.5 t=0.68 0.50

months of age

Weight increment between 6 to 12 months of age 2.6 ± 0.7 3.3 ± 0.5 t=3.15 0.001

Length at 12 months of age 77.5 ± 3.1 78.1 ± 3.1 t=0.26 0.80

Head circumference at 12 months of age 46.9 ± 0.5 46.3 ± 0.5 t=0.15 0.88

Weight at 12 months of age 10.4 ± 0.9 11.1 ± 0.5 t=8.45 <0.001

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 Table 3: Hematologic parameters of infants (Student’s t-test for independent samples).

Parameter Baby-led Traditional-fed Statistics P-value

Accepted Article
n=138 n=142

Mean ± SD Mean ± SD

Iron intake at 12 months of age 7.97 ± 1.37 7.90 ± 1.68 t=0.30 0.76

Hb† (g/dL) at 6 months of age 11.78 ± 0.58 11.74 ± 0.56 t=0.70 0.48

Hb (g/dL) at 12 months of age 12.28 ± 0.48 12.24 ± 0.41 t=0.64 0.52

Hematocrit (%) at 6 months of age 33.12  0.92 33.01  0.98 t=0.68 0.50

Hematocrit (%) at 12 months of age 36.75  0.85 36.23  0.81 t=0.70 0.48

MCV‡ (fL) at 6 months of age 74.3 ± 3.1 77,6 ± 3.7 t=1.65 0.10

MCV (fL) at 12 months of age 75.7± 2.2 75.9± 4.3 t=0.68 0.50

RDW§ (%) at 6 months of age 12.7±1.0 12.3±1.2 t=1.04 0.30

RDW (%) at 12 months of age 13.3± 0.7 13.6±1.3 t=0.84 0.42

TS¶ (%) at 6 months of age 17.46 ± 1.25 17.43 ± 1.18 t=0.16 0.87

TS (%) at 12 months of age 18.53 ± 0.65 18.49 ± 0.50 t=0.12 0.90

Ferritin (μg/L) at 6 months of age 18.33 ± 0.74 18.46 ± 0.63 t=0.11 0.91

Ferritin (μg/L) at 12 months of age 19.77 ± 0.88 19.24 ± 0.64 t=0.05 0.96

†
Hb: Hemoglobin,
‡
MCV: Mean corpuscular volume,
§
RDW: Red cell distribution width,
¶
TS: Transferrin saturation

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 Table 4: Weight for Lenght by WHO scores by complementary feeding group

(WHO have suggested a set of cut-offs based on single SD spacing. Thinness: less than -2SD,
overweight: between +1SD and less than +2SD, obese: more than +2SD.)
Accepted Article
WHO z score Baby-led Traditional-fed

group group

n (%) n (%)

-3 (-3.5 z <-2.5) 0 (0) 0 (0)

-2 (-2.5 z <-1.5) 3 (2) 0 (0)

-1 (-1.5 z <-0.5) 0 (0) 0 (0)

0 (-0.5 z <0.5) 119 (86) 96 (68)

1 (0.5 z <1.5) 16 (12) 22 (15)

2 (1.5 z <2.5) 0 (0) 16 (11)

3 (2.5 z <3.5) 0 (0) 8 (6)

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 Figure 1. Participant flow through the study
Accepted Article
Enrollment Assessed for eligibility (n=1522 )

Excluded (n=1220)
Not meeting inclusion criteria (n= 658)
5
Declined to participate (n=(426 )
Lived out of town (n=136 )
1
2
Randomized (n=302) 6

Allocation
Allocated to BLW group (n=156)
Received allocated intervention (n=151 )
Allocated to TSF group (n=146)
Did not receive allocated intervention (for health
reasons) (n= 5)

Follow-Up
Lost to follow-up (moved out of town) (n=6 ) Lost to follow-up (moved out of town) (n=6 )
Discontinued intervention (Urinary tract infection,
Discontinued ifrom study (Pneumonia) (n= 2 )
upper respiratory infection) (n=3 )

Analysis
Analysed (n=142) Analysed (n= 138 )
Weight,
) length, head circumference; serum Weight, length, head circumference; serum Hb, Hct,
Hb, Hct, Ferritin, Transferrin saturation; Iron
intake Ferritin, Transferrin saturation; Iron intake

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