CHAPTER - 3 Material and Methods -...

CHAPTER - 3

Material and Methods

3.1. Background information of the study area 113

3.1.1. Udupi District 113

3.1.2. Udupi taluk 114

3.2. Development of health education module 117

3.2.1. Intervention development 117

3.2.2. Formative Research 119

3.2.3. Pilot study 130

3.2.4. Health education approach 131

3.3 Main Study 132

3.3.1. Study design 132

3.3.2. Determination of sample size 136

3.3.3. Sampling procedure 137

3.3.4. Ethical committee approval 141

3.3.5. Registration 141

3.3.6. Recruitment of subjects 142

3.3.7. Screening for inclusion 142

3.3.8. Intervention Procedures 143

3.3.9 Channels of delivery of intervention 145

3.3.10. Follow up 146

3.3.11. Ascertainment of outcomes 147

3.3.12 Data collection 148

3.3.13. Assessment and monitoring 149

3.3.14. Participation rate 149

3.3.15. Intention to treat 150

3.3.16. Data analysis 150

3.3.17. Instruments used in the study 151

3.3.18. Procedures followed before administering the instruments 155

3.3.19. Procurement of tools 156

3.3.20. Training to conduct diet survey 157

3.3.21. Infant and Young Child Feeding practices (IYCF) Training 157

Materials and Methods Chapter-3

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3.1. Background information of the study area

3.1.1. Udupi District

Udupi is one of the twenty–seven districts in Karnataka state; a southern state in India

located about 381 km from Bangalore the state head quarters. It was formed on 24th

August,

1997, carved out of the erstwhile Dakshina kannada district with three taluks (Udupi, Karkala

and Kundapur) commonly known as “Tulu Nadu”. Udupi city is the district head quarters.

The district has 248 villages, 1 city municipality, two town municipalities and one town

Panchayath. As per the 2001 census165

, the total population of Udupi district was 11.12 lakh,

of which 5.22 lakh are males and 5.90 lakh are females and 82% of total population live in

rural areas. Male female ratio of 1000:1130 is one of the highest in the state. Udupi district

has recorded lowest population growth of 7.14% in Karnataka between 1991 and 2001 in the

state. As per the 2001census data, Udupi district has a literacy rate of 81.25% (male 88.23%

and female 75.19%) ranks third in the state. Educational infrastructure in the district is the

cynosure of many. There are 920 primary schools, 201 high schools, 73 Pre-university

(junior) colleges, 28 colleges and 9 professional colleges in the district. Transport network

within and outside the district is one of the best in the country. Well-connected

telecommunication facilities are available in all the villages. Hindus constitute 84% of

population followed by Muslims (11%) and Christians (4%). Agriculture, dairy farming and

fishing are the main occupations in the district. District has 13 large and medium scale

industrial units employing about 45,612 people.

The Human Development Index (HDI) in Udupi district (0.714) was 10 percent higher

than the State average (0.650) and 15 percent higher than all India average (0.621). It was

almost comparable with China. Udupi district ranks 3rd

among all districts in Karnataka in


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HDI. The health indicators clearly demonstrate that Udupi district is on the top rank in health

status in the State. The infant mortality rate (IMR), crude birth rate (CBR), Crude death rate

(CDR) and maternal mortality rate (MMR) was found to be 6.86/1000 live births, 12.9/1000

population, 5.35/1000population and 0.34/1000 live births respectively. In Udupi district

96.22% children get fully immunized, 98.81% pregnant women had safe delivery and 96.74%

pregnant women received full antenatal care. Proportion of low birth weight babies was found

to be 3.02%. Institutional deliveries constitute 97% of all deliveries. The child sex ratio in the

age group of 0 to 6 years was 991 females for 1000 males166

.

3.1.2. Udupi taluk

The study was conducted in Udupi taluk of Udupi District which covers a population

of 5.29 lakh, spread out in 115 villages. Udupi taluk has high literacy rate (85.14%) compared

to other taluks in the district. Udupi taluk is on the top rank in health status among the three

taluks of Udupi district. The infant mortality rate (IMR), crude birth rate (CBR), crude death

rate (CDR) and maternal mortality rate (MMR) was found to be 4.07 per 1000 live births,

12.01 per 1000 population, 5.55 per 1000 population and 0.21 per live births respectively.

Institutional deliveries constitute 97.74% of all deliveries. In Udupi taluk 96.57% children get

fully immunized, 98.78% pregnant women had safe delivery, and 96.11% pregnant women

received full antenatal care. Proportion of low birth weight babies was found to be 3.48 %166

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3.2. Development of health education module

3.2.1. Intervention development

A comprehensive educational Intervention package was developed during the first six

months of the study period. A formative research was conducted to seek information on

community characteristics, nutritional knowledge among mothers, and feeding practices. A

first draft module was developed using resource material on feeding practices with the help of

WHO, UNICEF167

and LINKAGES168

publications. The formative research findings and local

food habits, information and pictures from other local health education materials were used in

the module. The suggestions from specialists in community medicine and pediatrician were

incorporated and module was finalized.

1) The objectives of educational intervention

a. To bring about awareness and behavioral change among mothers to practice

proper breast feeding practices

b. To develop awareness and behavioral change among mothers to enable her to

adopt proper complementary feeding practices.

c. To educate the mother to provide adequate dietary intake to the child in terms

of calories, proteins and other nutrients

d. To improve awareness required to change behavior among mothers to follow

proper hygienic practices, immunization of children and also prevent and

manage common infections like Acute Respiratory Infection (ARI) and Acute

Diarrhoeal Disease (ADD).


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2) The contents of Health Education Module

1) Facts and problems of child malnutrition

2) Significance of initiation of breast feeding, exclusive breast feeding, feeding

colostrum

3) Common breast feeding difficulties and prevention

4) Breast feeding in three special situations

5) Immunization of children

6) Significance of growth monitoring and use of road to health card

7) Vitamin A prophylaxis

8) Feeding practices during illness

9) Initiation of complementary feeding

10) Nutritional value of local available foods and the dietary requirement (in terms

of quantity and quality)

11) Optimal feeding practices (FADUA)

12) Introduction of family foods

13) Negotiating behavior change to enable proper breast feeding and

complementary feeding practices

14) Prevention of common illnesses like ADD and ARI etc.

15) Home management of ADD

16) Standard case management of ARI

17) Proper hygienic practices


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3) Channels of delivery of educational intervention:

1) One to one discussion at home, Individual counseling, Road to health card

2) Negotiate with the husband and mother-in-law (or other influential family

members) to support the mother.

3.2.2. Formative Research

1. Introduction:

Formative research is research that occurs before a program is designed and

implemented to help ‘form’ or modifies a program. Formative research should be an integral

part of developing a program or adopting a program, and should be used to help refine and

improve program activities. Formative research is conducted in the early stages of designing a

health communication program to understand the current practices, motivators and barriers

related to ideal behaviors. It also defines the acceptability and feasibility of adopting a new

behavior, target audiences, convincing messages for each audience, the channels and the ideal

frequency for exposure to the messages. Formative research helps program planners and

implementers identify specific behaviors to promote; identify the knowledge, motivators, and

barriers to desired behaviors that messages need to either overcome or strengthen; and

identify central themes and messages comprising for interventions. Trials of improved

practices (TIPS) help to test recommendations and determine which ideal behaviors are

possible in certain contexts, which need to be modified and which are not feasible at all in the

area. A comprehensive health education strategy can be developed based on the findings of

formative research169

. (Appendix 2)


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2. Objective

1. To develop a module of health education for mothers regarding culturally

sensitive, appropriate and locally acceptable infant and young child feeding

practices to improve the nutritional status of children.

3. Methodology:

This study was taken up to design a health education module to educate mothers to

improve feeding practices. The formative research included existing data review, in-depth

interviews, household observations, trials of improved practices (TIPS), diet survey (24-hour

recall method) and focus group discussion (FGD). The purpose of the study was to narrow

down the range of feasible and acceptable feeding practices for mothers to improve the

growth pattern and feeding practices. This study was conducted in the field practice area, in

two Rural Maternity and Child Welfare Homes (RMCWH) of Kasturba Medical College,

Manipal Karnataka. The study population was mothers of children less than 2 years of age,

pregnant women and elderly and influential women from the community.

3.1. Study area: The study was conducted in the field practice area of Kasturba Medical

College Manipal. A convenience sample was selected from two Rural Maternity and Child

Welfare Home (RMCW Homes) area.

3.2. Sample selection: There are six RMCW Homes in field practice area. Out of this, two

RMCW homes were selected by a simple random sampling method. In the RMCW homes one

field ANM working in the field keeps a family record. Four groups were identified for the

study. Pregnant women, mothers of children aged birth to 6 months, 7 to12 months, 13 to 24

months. Four groups were listed separately from the available records and five families were


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selected in each group in both centers for the study adopting a simple random sampling

procedure.

Sl.No. Study group Age group Sample

1 Pregnant women 36 to 38 weeks of gestation 5

2 Mothers of children 0 to 6 months 5



a) In-depth interview: A semi structured questionnaire was used to interview the mothers at

their homes. Five mothers in each group; pregnant women and mothers of children aged 0

to 6 months, 7 to 12 months; 13 to 24 months were included in the study. The mothers were

interviewed to gather the information on knowledge, attitudes and practices regarding

breastfeeding, complementary feeding, and care of sick children and to identify the barriers

for optimal breast feeding and complementary feeding practices. The in-depth interview was

30 to 45 minute. (Appendix 3)

b) Trials of improved practices (TIPS): Trials of improved practices have been used to test

the recommendations on feeding practices. After the in-depth interview the mothers,

caregivers and family members were involved in a discussion to try one or more

recommended practices. Mothers were advised on frequency of breastfeeding, adding oil/ghee

etc. in food, giving fruits and vegetables, frequency, quantity and consistency of feeding

complementary foods, adding varieties of foods etc. were the important topics included in

discussion. During the follow up visit mother were enquired about their experiences,

observations were made about the feeding practices, and improvements were noted down.

When trials are conducted with women and caregivers, the recommendations are tailored to


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their needs and situations, so that respondents can actually test the new practices and talk

about their experiences. TIPS observation took about 30 to 40 minutes (Appendix 3)

c) Diet Survey (24-hour diet recall method): A diet survey was conducted using a 24-hour

diet recall method to know actual quantity, types of food, frequency of feeding etc. The diet

survey in the selected five families in three groups was conducted using the standardized

proforma developed in National Institute for Nutrition (NIN). Information was collected from

mother on previous day in 24 hours what all she fed to child including breastfeeding

frequency. The food was measured by the standard cup from NIN. Food quantity and types of

foods and frequency of foods were assessed. On the basis of these findings healthy feeding

practices were recommended to the mothers and care-givers. The report was prepared and

findings were used in health education module.

d) Focus group discussion (FGD): Two RMCW homes were randomly selected from the

field practice area of Kasturba Medical College Manipal. Two focus group discussions were

conducted consisting of mothers of children less than 2 years of age, pregnant women and

influential women from the community. We selected the similar group of mothers and others

to find out their experiences and those who are influencing the mothers in deciding the

feeding practices. They were selected from the field practice area of two Rural Maternity

Homes. The study details and purpose was explained and oral consent was obtained. One

trained female moderator assisted by researcher led both group discussions. Focus group

discussions were conducted using a semi-structured moderator’s guide and the whole process

was audio taped with the participant’s permission. Focus groups were involved in two-hour

long discussion. The questions for discussion included breastfeeding problems, exclusive


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breastfeeding, complementary foods, family diet, care of sick child, hygienic practices etc.

(Appendix 4)

e) Summary of findings of focus group discussion: The observations, experiences,

practices, attitudes, beliefs of the mothers, which formed the conceptual framework to

formulate educational approaches, are given below. These are in response to the questions we

have asked during the focus group discussion.

Q.1. Child malnutrition is one of the important health problems we face in our area. Nearly

35% of our children are below the age of 2 years are malnourished – Do you agree?

We agree what you are saying but we cannot see such children or we cannot make out.

Q.2. Breast milk is the natural food available to a child from her mother, but how this is fed

to a child?

a) Initiation of breastfeeding – Soon after the birth it is possible and child has to

be given breast milk within 10 minutes of delivery.

b) Prelacteal feeds – Some are giving lactogen milk, glucose water, sugar water,

honey, hot water before giving breast milk. We are not giving any thing other

than breast milk.

c) Feeding colostrum – Earlier some mothers are squeeze and through it. Now

everybody gives. It is good nutritious food and child is protected by sickness.

d) Exclusive breastfeeding – Only breast milk is enough for 3 to 4 months of age,

some semi solids to be started at 4 months of age and fed two times per day.

e) Breastfeeding in night – Night 2 times breast milk has to be given, if child

sleeping long has to woke up and fed, night and day breast milk has no

difference.


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f) Duration of breastfeeding – breastfeeding has to be continued till 18 months,

after one year child starts bite the breast so some stop, to stop later at 2 years

we get pain so we stop early. Child should be breastfed 2 years or 3 years (few

mothers).

g) Positioning – Breastfeeding should be in sitting position not sleeping position

because child vomits, breast has to be cleaned before feeding, child

attachment, love and mother is to be calm during feeding. Mother has to take

milk, hot water and green leafy vegetables. Child take 5 to 10 minutes for

breastfeeding, if loner time and more frequent feeding will make the mother

week and anemic.

About nipple feeding no answer

h) Breastfeeding problems – Problems like swelling, hardness, crack nipple.

One side should be fed first and then the other side.

Q.3. Breast milk alone is enough only to a certain age, what has to be fed afterwards?

In addition, how these foods are fed?

1. Introducing complementary foods – At 4 months semi solid foods should be started

(biscuits, bakery butter, apple, other fruits, carrot boiled etc.) After 6 months –ragi,

wheat, beaten rice, rava, biscuits, fruits, butter (bakery), cereleac, etc. After 8 months

kanji and dal will be started, egg and cow’s milk also can be given. Breast milk is

not enough after 4 months additional milk has to be started. During other foods are

introduced child is getting problems because change in foods. Child does not have

energy to digest new foods.


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2. Frequency of feeding – At 4 months 2 times, after some time 4 times, at 6 months 3

times, and slowly increase at 9 months, and at 9 months, biscuits and other foods can

be added.

3. Types of foods – Feed should be watery when introduced, and it can be little thick not

very thick, idly, banana, beaten rice with milk, porridge, mashed potatoes, kanji will

be given. After 9 months thick and hard food can be given.

4. Introducing family foods – After 9 months, family foods are given what the elders eat

at home. Start giving all food items what family eats in small quantity; serve in

separate plate, at one year. Only at 18 months child is able to eat family foods.

5. Continuing family foods – breast milk is given until 18 months of age, some children

are very much for breast milk and do not eat other foods. Breast milk can be stopped

when child is not eating well other foods. After 18 months, breast milk is not required.

Q.4. Is there any way that we can prevent few sicknesses? What are they and how?

Immunization – through immunization BCG, Jaundice, MMR, Malaria, DPT, OPV.

However, majority do not know correct dose and time. Doctor tells that time we take

the child and children are immunized.

Q.5. If child is sick usually, what do you do? Is there any way to prevent or reduce the

severances of these sicknesses?

a) Home management of ARI – We try with home medicines like ginger, tulsi

etc. for one two days if not severe otherwise take the child to doctor. We keep

ice water, wet cloth during fever on forehead.

b) Home management of Diarrhoea – usually during teething, we give ORS,

sugar and salt water, ararroate boiled water, if more than one day taking the


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child for doctor. Child feeds should be clean, hot foods and left out should not

be given; hand should be washed before feeding the child with soap and water

also after using toilet.

c) Hygienic practices – Washing the hands and plates before feeding the child,

keeping the surrounding clean, using boiled water for drinking.

Q.6. Usually we learn many things from others, child feeding practices are concerned who

is the motivator for you and which are the motivating factors?

Doctors, ANM’s, Anganawadi workers, and elders at home – Doctors tell do not give

diluted milk, banana etc. but elder at say don’t give, child will get cold and cough milk

has to be diluted. ANM’ and anganawadi workers also give suggestions but children

do not eat the way they tell. At home, elders say do not give milk for 5 years child will

get cold and cough. We have listened to elders at home; sometimes we take our own

decisions. Some have chubby children we ask the mother how they feed their child.

We have listen child’s father, mother–in-law, mother and sometimes neighbors.

However, we cannot follow everything. We follow our own ideas some times.

Sometimes financial constraints, not confident, child will not eat etc.

Q.7. Many a time health professional’s advice a lot of ideal feeding practices, but it may

not be possible to practice them in a day today life? What are the barriers in

practicing these ideal practices?

a) Growth monitoring – When we go doctor or anganawadi they weigh the child

tells weight is correct or not. Child should be weighed every month, but we

know the growth and activities


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b) Feeding gripe water – It is given to children, advised by doctors, twice to be

given, good for digestion, sleep, and stomachache. Doctor advice to give good

for digestion, during discharge after delivery doctor advices. It should not be

given, not good for health (two mothers).

c) Giving multi vitamins – Doctor advices to give 8 drops per day up to 6

months/sometimes till one year.

d) Herbal medicines – Ayurvedic medicines grinded paste ones a week. It

improves speech (clear speech), children start talking fast, for irritating

children good. Elders at home advice to give. Oil massage is good, child sleeps

well. Doctor advises not to give oil massage.

e) Anganwadi food – Child does not eat this food, children could not tolerate it is

good can be given.

Q.8. If a health professional visits to your house to discuss about feeding practices, in such

a occasion do you like your mother-in-law, husband or any other family members to

be present in the discussion? In your opinion what is the suitable time for such visits?

No problem, it is good if mother-in-law husband is there. They also will come to

know the problems and good for us. If all are there also good, in some times mother-

in-law is there good but for some it is not good irritating. (One mother)

Q.9. Whom do you call as healthy child?

Active child, playing, not irritating, having good sleep, passing motion regularly,

according to age weight is increasing, eating properly, activities are according to age.

f) The diet chart: The diet chart was prepared based on the results of diet survey, in-depth

interview, and focus group discussion. Frequency of feeding, local food items, required


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quantity variety of foods was included in the diet chart. These diet charts were field-tested

while field testing the module by the researcher and supervised by the Guide.

4. Health Education Module:

A draft module was developed using resource material on infant feeding practices of

WHO, UNICEF etc. The formative research findings and local food habits, information and

pictures from other local health education materials were used in developing the module.

Pediatrician, Communication specialist, Nursing specialist, and Community Medicine

specialists were consulted and their advice was taken in finalizing the module. The module

was prepared in English and the same was translated into Kannada (local language). One wall

poster was prepared using the important aspects from the module. The module was converted

into a flip chart to use it as an educational tool to talk to the mothers while imparting the

health education intervention. (Appendix 5, 6, 7, 8)

5. Following topics were addressed in the module:

1. New born care: Breast feeding, care of low birth weight baby, feeding pre-

lacteal feeds, proper positioning, optimal breast feeding practices, bottle

feeding, danger signs of illness, immunization schedule, growth monitoring,

hygienic practices, home management of illness like diarrhea, ARI and fever

and nutritional advice for mothers.

2. Infant care (0 to 6 months): Exclusive breast feeding, proper positioning,

optimal breast feeding, bottle feeding, danger signs of illness, immunization,

growth monitoring, hygienic practices, milestones of development, and home

management of illness.


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3. Infant care (7 to 12 months): Breast feeding, complementary foods, dietary

advice with diet chart, optimal feeding practices, immunization, growth

monitoring, hygienic practices, milestones of development, and home


4. Child care (13 to 24 months): Continue breastfeeding, introduce family foods,

dietary advice with diet chart, optimal feeding practices, immunization, growth

monitoring, hygienic practices, milestones of development, and home


5. Diet chart: Locally acceptable and nutritionally appropriate diet chart was

prepared and field-tested and incorporated in the module.

6. Breast feeding management in special situations: In this section, breastfeeding

in special situations was discussed. This included feeding the sick child,

feeding the child when mother is sick, how to feed a malnourished child,

feeding by working mother and during pregnancy etc.

7. Common breast feeding difficulties: The common breastfeeding difficulties are

discussed in this section. The breastfeeding problems like engorgement, sore or

cracked nipples, not enough breast milk or insufficient breast milk, plugged

ducts, mastitis etc.

8. Child feeding problems and few solutions: Some of the common feeding

problems are listed and discussed in this section. How to counsel the mother

and what are the suggestions and how to counsel the mother to improve the

situation was highlighted in this section. (Appendix 9)


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6. Content validity: To determine content validity of the module the draft module along with

the criteria checklist was submitted to five experts. Among the five experts, two were from

Department of Community Medicine, one each from Department of Pediatrics, Nursing

College and Institute of communications. (Appendix10) There was 100% agreement on the

content presentation and language used. There were few suggestions on the pictures and

colors by the experts. The suggestions were well taken care and necessary changes were done

in the final draft.

7. Development of the criteria checklist: The criteria checklist was developed by the

investigator. The criteria checklist consisted of different topics included in the module, under

the headings selection of content, organization of content, presentation and language. The

checklist had three responses columns i.e. Agree, Disagree and Remarks columns for any

suggestions of the experts.

8. Translation of the module: After the validation, the module was translated into Kannada

by language expert. Another language expert then retranslated the Kannada version of the

module to English. The researcher verified both. There was no difference in sentence

construction. One pictorial wall poster was prepared using the important aspects from the

module. The Kannada version of the module was converted into a flip chart to use as an

educational tool to talk to the mothers while imparting the health education intervention.

(Appendix-8, 9, 10)

3.2.3. Pilot study: A pilot study was conducted in two villages. The specific purpose of the

pilot study was to determine the feasibility of the design and to develop and test the feasibility

of intervention. The subjects included were similar characteristics as the study population.


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The Kannada version of the module was tested on five mothers in each group (pregnant

women, mothers having children below 6 months, mothers having children 7 to 12 months,

and mothers having children 1 to 2 years). Oral consent was obtained by the subjects after

explaining the purpose of the study. The study was aimed to determine the clarity of

messages, presence of ambiguous items, time taken to complete the session, difficulty in

understanding the scientific terms, feasibility and acceptability by the mothers. All the items

were clear and understandable. The total time taken to complete the each session was 30

minutes to 45 minutes. The response from the mothers was very encouraging and receptive.

The study design and the educational intervention at family level adopting the one to one

counseling approach was found to be feasible.

3.2.4. Health education approach: Breastfeeding Promotion Network of India (BPNI) 7

has

suggested that model of one to one individual counseling has the potential to increase

exclusive breastfeeding substantially at one to 6 months significantly. In addition, it has

suggested that complementary feeding can be enhanced by individual and group counseling.

In addition, study done in Peri-urban Mexico19

suggested that model of home based peer

counseling was effective in promoting breastfeeding. We have conducted formative research

to develop the conceptual frame work that guided our choice of channel of communication

and educational approaches. In India, based on our review no studies have been done on the

role of family members and their influence on mothers regarding infant feeding practices. In

our formative research we found that mothers value the advice from mother-in- law, mother

and husband regarding infant feeding practices. So we have involved them. The formative

research findings shows that mothers felt one to one individual counseling was acceptable

and likely to be more effective. So we have chosen this approach. (Appendix11)


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3.3 Main Study

3.3.1. Study design:

a) A community based two-arm cluster randomized controlled trial

Udupi taluk has 20 circles as per the administrative structure of the ICDS project.

Circle means a specific geographical area consisting of a group of anganwadi centers on an

average 25 anganwadi centers. (Flow Chart, Fig. 3.2)

Fig No. 3.2


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Fig no. 3.3: Flow chart

Udupi Taluk- 20 Circles (ICDS - Project)

Six circles

7anaganwadies (Clusters) Registered all pregnant

mothers- (37)

7anganwadies (Clusters) Registered all pregnant

mothers (40)

Total -40 children

Lost for follow up - 5

(2 Infant deaths, 3 left the place)

35 children

Assessment of outcome

35 children

Total 37 children Lost for follow up - 3

(1 Home delivery, 2 left the place) 34 children

Assessment of outcome

34 children

Exclusion – 1 4 circles in field practice area of Kasturba Medical College

Exclusion – 2

10 circles beyond 10 km. away from Manipal

Intervention group (Kolalgiri)

(24 Anganwadies)

Control group(Pernakila)

(16 Anganwadies)

Two circles

Simple random

sampling procedure

Randomization

Follow – up (24 months)

Simple random sampling procedure

Simple random

sampling procedure


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In this study an attempt was made to evaluate the effectiveness of an educational

intervention to mothers on growth of the children, the improvement in consumption of dietary

energy, proteins, energy density and different type of foods, feeding practices, hygienic

practices and infections. In such kind of educational intervention studies, individual

randomization is not advisable because of the interaction of family members in the

community between the two groups will lead to contamination170

. (Appendix1) Although

anganawadi was considered as cluster in our study, randomization was done at the level of

circle to avoid contamination between the clusters (anganawdies) of the intervention and

control group.

In each circle, seven anganawadies were selected by simple random sampling

procedure. Anganawadi was considered as a cluster in the study171

.

Out of the 20 circles, four circles which come in the field practice area in Kasturba

Medical College, Manipal were excluded. This was done as domiciliary maternal and child

health care services were provided by field health workers (ANM’s) of Kasturba Medical

College, Manipal in this area and including these circles will lead to selection bias. (For

details see sampling procedure)

For the intervention, the researcher has to visit each family eight times during the

study. For registration and assessment of outcome measures researcher has to visit each

family in intervention and control area ten times (for details see in this chapter 3.37 and 3.38).

Considering the logistic reasons in terms of number of follow-up visits in intervention group

(18 visits /family) and in control group (10 visits/family), duration and distance it was decided

to take up only one circle for each group (intervention and control) within the radius of 10


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km. around Manipal. Those circles (10 circles) beyond the distance of 10 Km. away from

Manipal were excluded. Out of six circles remaining two circles were selected for the study

by simple random sampling procedure. (For details, see sampling procedure)

b). Randomization:

The two circles selected were subjected to randomization procedure by which one

circle formed the intervention group and other circle formed the control group.

The minimum sample size determined for our study was 33 children in intervention

group and 33 in control group (see section 3.3.2 for details). Expecting five to six deliveries in

6-month time in one anganawadi center it was assumed that seven anganawadi centers in each

group will provide the required number of subjects for our study. A list of anganawadi centers

was obtained from the ICDS office for both circles and by simple random sampling method;

seven anganawadies were selected in each circle by the Statistician. (For details, see sampling

procedure) All the pregnant women in the third trimester were registered for the study in the

respective anganawadi centers till the required number of subjects as per the minimum sample

size for the study was met (33 subjects in intervention and control group).

All the pregnant women in the third trimester in the respective anganwadi centers were

registered during a period of nine months (November 2006 to July 2007). The registered

women were 40 in intervention group and 37 in control group. Out of 40 new born children in

the intervention group 5 children were lost for follow up. Likewise, out of 37 newborn

children in control group 3 children were lost for follow up. The children were lost for follow

up due to home delivery, infant death, and migration. Finally, 35 children in intervention


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group and 34 children in control group, which meets our minimum sample size, were included

and assessed in our study.

3.3.2. Determination of sample size:

To achieve the equivalent power of a patient randomized trial, standard sample size

calculation was inflated using appropriate sampling method referred as the “design effect”. In

this study, only one group was allocated for intervention and the intra cluster correlation was

taken into consideration for the sample size calculation172

.

The ICMR study conducted in 1984173

showed the mean weight of Indian children at 2

years of age to be 10.1 kg. The WHO3 recommendation of the cut off point for normal birth

weight 2.5 kg and birth weight of Indian children 2.5 kg (-2sd) was taken in to consideration.

The sample size was calculated assuming the children in the intervention group will

gain 10% more weight than the control group children at the end of 2 years. Children with a

normal birth weight of 2.5 kg would gain 7.6 kg at 24 months of age in control group. The

sample size for the number of individuals for the study was calculated for 80% of power and

95% confidence interval (CI) for the primary outcome. The sample size was calculated using

the following statistical formula.

Further it was anticipated that there shall be 15 % loss to follow up during each time

point of the anthropometric measurements. The sample size was calculated for seven repeated

measurements (4, 6, 9, 12, 15, 18, and 24 months) with an intra cluster correlation coefficient

2 (z + z !)2 ("

2/k (1+ (k – 1)) P)

#2

= 33


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of 0.3 (P)42

and standard deviation (SD) of 1.09Kg (Pilot study conducted in this area). To

account for the cluster design we took design effect of 1.5, the sample size was fixed for 33

children in each group (intervention and control group).

3.3.3. Sampling procedure: (Fig.no.3.4 & 3.5)

As per the administrative structure of the ICDS project in Udupi taluk it has 20 circles

which are given below.

1. Saibarakatte 2. Pathri 3. Kokkarne 4. Brahmavara

5. Kota 6. Kemmannu 7. Saligrama 8. Barkoor

9. Avarse 10. Kukkehalli 11. Kolalgiri 12. Padubidri

13. Moodabettu 14. Kaup 15. Shirva 16. Manipura

17. Pernakila 18. Herebettu 19. Hiriyadka 20. Malpe

The following four circles were excluded from sampling frame which are included in

the field practice area of the Department of Community Medicine, Kasturba Medical College

Manipal.

1. Moodabettu, 2. Kaup, 3. Manipura, 4. Malpe.

For the logistic reasons the following 10 circles were excluded from the sampling frame work

which are beyond 10 Km. away from Manipal.

1. Saibarakatte 2. Pathri 3. Kokkarne 4. Brahmavara 5. Kota

6. Saligrama 7. Barkoor 8. Avarse 9. Padubidri 10. Shirva

The six circles included for the study are -

1. Kemmannu 2. Kukkehalli 3. Kolalgiri

4. Pernakila 5. Herebettu 6. Hiriyadka


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Fig no. 3.4


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Out of the above six circles two circles were selected by a simple random sampling

procedure.

The two circles identified which were subjected for randomization are -

1. Kolalgeri circle 2. Pernakila circle

In the second stage all the anganwadies in both circles were listed alphabetically and

in each circle seven Anganwadies were selected by draw following simple random sampling

procedure. An additional two anganwadies were selected in case of any dropouts.

All the procedures were done under the guidance and presence of a Statistician who is not

involved in the study.

Intervention group Control group

Kolalgiri Circle Pernakila circle

Selected anganwadi centers Selected anganwadi centers

1. Golikatte 1. Nellikatte

2. Kelinje 2. Kappanthakaria

3. Herebettu 3. Moodabettu

4. Padunittur 4. kudi (82)

5. Dompada Kumeri 5. Bhiranje

6. L.V.P.1. 6. Devaragudde

7. Muggeri 7. Kattangeri

Additional anganwadies in case of non response

1. Uggelbettu 1. Onthibettu

2. L.V.P. -2. 2. Pernakila


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Fig. no. 3.5: Sampling procedure used for selection of circles and anganawadies

Udupi taluk - 20 circles

Excluded 4 circles – Field

practice area 1. Moodabettu 2. Kapu

3. Manipura 4. Malpe

Excluded 10 circles – Beyond

10 Km. distance 1. Saibarakatte 2. Pathri

3. Kokkarne 4. Brahmavara

5. Kota 6. Saligrama

7. Barkoor 8. Avarse

9. Padubidri 10. Shirva

Included in the Study – 6 circles1. Kemmannu 2. Kukkehalli

3. Kolalgeri 4. Pernakila

5. Herebettu 6. Hiriyadka


Two circles

Kolalgeri and Pernakila

Selected Anganwadies (7) 1. Golikatte 2. Kelinje

3. Herebettu 4. Padu-Nittur

5. Dompada Kumeri 6. L.V.P.1.

7. Muggeri

Selected Anganwadies (7) 1. Nellikatte 2. Kappandakaria

3. Moodabettu 4. Kudi – 82

5. Bhairanje 6. Devaragudde

7. Kattingeri

Control group

Pernakila

16 Anganwadies


Intervention group

Kolalgiri

24 Anganwadies

Randomization


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3.3.4. Ethical committee approval: The study proposal was submitted to the Institutional

Review Board (IRB). The 14 member review board reviewed the proposal and the researcher

was questioned for the clarifications. The Study proposal was approved by the IRB (Kasturba

Hospital Ethics Committee) on 10th

April 2006 (proposal No. 79/2005). (Annexure 12)

3.3.5. Registration: The Child Development Project Officer (CDPO) was contacted and his

co-operation was requested. All the anganwadi workers of the selected two circles were

contacted separately and explained about the study. A list of all the pregnant mothers enrolled

with them was obtained. In the selected anganwadi centers of both groups (seven

anganwadies in intervention and seven anganwadies in control) the pregnant mothers who

were in last trimester of pregnancy and permanent residents of that area were registered.

(Appendix 13&14) All the pregnant mothers whose gestational age was 36 to 38 weeks and

who are residing permanently in that area were visited by the researcher. The mother

/caregiver were explained about the purpose of research, the potential risks and benefits of the

study and a copy of informed consent was provided to the participants. A child is legally

unable to provide informed consent. Therefore, proxy consent was obtained from the child’s

mother / caregiver174

.

a) Consent: The mother /caregiver were explained about the purpose of research, the

potential risks and benefits of the study and a copy of informed consent was provided to the

participants. A child is legally unable to provide informed consent. Therefore, proxy consent

was obtained from the child’s mother (Appendix 15)

b) Inclusion criteria: All the newborn babies born to mothers’ permanently residing in the

area were included for the study.


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c) Exclusion criteria: Any child with congenital malformation; pre-term babies; mothers who

had home delivery; and when birth weight of the child was not available, the families were

excluded from the study.

3.3.6. Recruitment of subjects: In the selected anganawadi centers of both groups

(intervention and control) the pregnant mothers who were in last trimester of pregnancy and

permanent residents of that area were registered. All the pregnant mothers whose gestational

age was 36 to 38 weeks and who are residing permanently in that area were visited by the

researcher. The purpose and details of the study was explained and a written consent was

obtained. A base line knowledge assessment was done using a pre-tested questionnaire.

Within the 2nd

week of the delivery, the child was recruited for the study if the child was

fulfilled all inclusion criteria. Recruitment was continued till the required sample size was

met. All the existing health services and programs were continued as routine activities. A pre-

tested schedule was used to collect the information on birth weight, other anthropometric

measurements, feeding practices and socio-demographic data. Revised Udai - Parikh scale175

was used to collect the information on socio-economic status of family. The dietary practices,

hygiene, frequency of infections were recorded interviewing the mother.

3.3.7. Screening for inclusion: A brief questionnaire was developed to assess the eligibility.

All the children were contacted within 15 days of birth at either home or hospital to assess the

eligibility and to recruit for the study. Those children contacted at home were assessed for

eligibility by the investigator by referring the discharge summary to identify any

abnormalities as per the questionnaire. Children contacted in the hospital the eligibility

criteria of the children born in the hospital were assessed by investigator based on


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consultation of the treating doctor. Each child was assessed according to the screening criteria

and recruited for the study. (Appendix16)

3.3.8. Intervention Procedures: The intervention procedure was started immediately after

the pregnant women were registered for the study. Researcher himself did the intervention. In

the intervention group the intervention was carried out as follows. In the selected seven

Anganawadi centers allotted for intervention a list of all the pregnant women were prepared.

During the third trimester researcher visited the pregnant women’s house along with the

anganawadi worker. Anganawadi worker introduced the researcher and told the purpose of the

visit. Researcher introduced himself and distributed the information sheet. Those women who

can read Kannada were given the information sheet and made them to read and any doubts

were cleared. In case of illiterate mothers the other family members were read for them. A

written informed consent was obtained from pregnant women. Initially baseline knowledge,

socio demographic characteristics, socio-economic status of the family was assessed.

Following this researcher stated the counseling session. Researcher initiated the discussion

asking few open ended questions to find out pregnant women’s feelings and perceptions.

Thereafter the flipchart was introduced and explained.

1. During the first visit (3rd

trimester of pregnancy) the discussion was focused on mother’s

nutrition, place of birth, and feeding practices. More stress was focused on initiation of

breastfeeding, prelacteal feeds, feeding colostrum holding the child in correct position

(pictures were shown) and common breastfeeding problems.

2. Second visit (2 months of age for the child) the focus was on continuing breastfeeding

assessing the breastfeeding position, immunization schedule, exclusive breastfeeding.

Common breast feeding difficulties and prevention, breast feeding in special situations,


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significance of growth monitoring, use of road to health card, proper hygienic practices,

prevention of common ailments, time of introducing complementary foods, taboos, food fads,

local cultural practices, problems of bottle feeding etc.

3. Third visit (5 months of age for the child) the researcher was talking to the mother on the

exclusive breast feeding, initiation of complementary foods, continue breast feeding, balanced

diet chart, optimal feeding practices (FADUA), common breast feeding difficulties and

prevention, immunization of the child, proper hygienic practices (mother and child),

prevention of common ailments, taboos, food fads, local cultural practices, problems of bottle

feeding and any other problems mother facing about feeding the child.

4. Fourth visit (8 months of age for the child) the topics covered were continuing breast

feeding, starting family foods, balanced diet chart and variety of foods, optimal feeding

practices (FADUA) and making the child feed himself, immunization of the child, proper

hygienic practices (mother and child) and prevention of common ailments.

5. Fifth visit (11 moth of age for the child) the following topics were discussed. Continuing

breast feeding, starting family foods, balanced diet chart and variety of foods, optimal feeding

practices (FADUA), proper hygienic practices (mother and child), prevention of common

ailments and any other problems.

6. Sixth visit (14 months of age for the child) the researcher was talking on the topics such as

continuing breast feeding, balanced diet chart and variety of foods, optimal feeding practices

(FADUA), immunization of the child, proper hygienic practices (mother and child),

prevention of common ailments and any other problems faced y the child.

7. Seventh visit (16 months of age for the child) the topics focused were continue breast

feeding, balanced diet chart and variety of foods, optimal feeding practices (FADUA), proper


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hygienic practices (mother and child), prevention of common ailments and any other

problems.

8. Eighth visit (20 months of age for the child) the researcher focused the following topics

continue breast feeding, balanced diet chart and variety foods, optimal feeding practices

(FADUA), common breast feeding difficulties, proper hygienic practices (mother and child),

prevention of common ailments and any other problems.

The intervention counseling was in the locally accepted language. The pictorial

calendar with adequate and easily acceptable messages of recommended practices was

distributed to all mothers in the intervention group.

3.3.9. Channels of delivery of intervention: Looking into the different approaches adopted

by different study groups we considered contacting the mother directly at home and

counseling will be more effective. Therefore, we adopted a family level counseling to deliver

the intervention. The researcher was told to conduct the intervention himself. Few studies also

suggested that individual as well as group counseling will be an effective way improving

feeding practices among mothers7, 19

. The pregnant women were contacted at home

introduced by ICDS worker. Pregnant women and the family members (others who ever

available at home) were clearly explained about the study and consent was taken. Later the

intervention counseling was started. Initially few open ended questions were asked and the

mother and other family members were allowed to respond on child feeding practices and

child care. Listening to them, reflecting back what they think empathize them accept what

they do right, recognize and praise for good practices. At the end give very few specific

suggestions and appropriate information to the mother and family members. Try to find out


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the feasibility and acceptability of adopting the new suggestions. During the next visit follow

up the previous problems and suggestions given to them. If not followed try to find out what

was the problem and try to solve them176

.

Negotiation: While counseling involving the mother and other family members at home

(whoever is available) listen what they say, their experiences, feelings and practices. Try to

identify which are good practices followed and encourage them and try to find out which are

the wrong ones. When they are practicing a wrong practice discuss and try to make them

understand why it is not a healthy practice. Here we have to give an option for them to change

their practice and see the results so that they will change their behavior.

3.3.10. Follow up:

a) Intervention group - During the registration the contact address and telephone number

was obtained to find information about delivery. Anganwadi workers were contacted to find

out the place and time of delivery. Within two weeks of delivery the mother was contacted

either in hospital or at home. All the infants were recruited for the study. Newborn particulars,

information on feeding practices were collected from the mother using a pretested

questionnaire. The anthropometric measurements were noted down from the discharge

summary or hospital inpatient record. All the children in intervention group were visited at 4

months, 6 months, 9 months, 12 months, 15 months, 18 months and 24 months of age of

infant. Information on feeding practices, hygienic practices, and dietary assessment through a

24-hour recall diet survey was collected. The anthropometric measurements were taken as per

the standard procedure and recorded each time separately. Each child was followed up till

completion of 24 months of age. Exclusively the researcher did the data collection.


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b) Control Group: In all the selected seven-anganwadi areas all the pregnant mothers during

the third trimester were contacted through the anganwadi worker. Registration procedure was

followed in control area similar to intervention area. All the infants were recruited and

newborn information was collected. Data collection was done following the same procedure

as done for intervention group and all the children were followed up till they completed 24

months of age. All the children in control group were visited at 4 months, 6 months, 9

months, 12 months, 15 months, 18 months and 24 months of age of infant. Information on

feeding practices, hygienic practices, and dietary assessment through a 24-hour recall diet

survey was collected. Mothers have not received any kind of intervention from the

investigator. Any kind of health activity was considered as routine activity. Exclusively the

researcher did the data collection.

3.3.11. Ascertainment of outcomes:

1) Out comes were assessed comparing the intervention group with control group.

a). Anthropometric measurements weight, height, head circumference, chest circumference

and mid arm circumference at birth and at completion of 4, 6, 9, 12, 15, 18, 21, and 24 months

of child’s age.

b). Dietary intake of foods in terms of quantity, quality and type foods at completion of 6, 9,

12, 18 and 24 months of a child’s age.

c). Feeding practices among the mothers included breastfeeding, complementary foods,

introduction of family foods, feeding any other foods etc.

d). Hygienic practices followed by mothers and proportion of children who suffered ARI and

ADD.


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2) Independent variables: Baseline characteristics form the independent variables to

compare intervention group and control group included

Child: Gender of the child

Mother: age, education, occupation, parity, mode of delivery, age at marriage, Gestational

age, number of antenatal visits, duration hospital stay and base line knowledge

Father: age, education, occupation

Family: Socioeconomic status, religion

3.3.12. Data collection

A pre-tested questionnaire was used to collect information from mothers on the following.

o Socio demographic details during 3rd

trimester

o Assessment of Socio- economic status during 3rd

trimester

o Baseline Knowledge assessment during 1st visit at 3

rd trimester

o New born details within 15 days of delivery

o Feeding practices at birth, and later at completion of 4, 6, 9, 12, 15, 18, and 24 months

of child’s age

o Diet survey using 24–hour recall method at completion of 6, 9, 12, 18 and 24 months

of child’s age.

o Anthropometric measurements at birth, and later completion of 4, 6, 9, 12, 15, 18, 21,

24 months of child’s age.

o Hygienic practices and common infections at completion of 4, 6, 9, 12, 15, 18, and 24

months of age.

Data collection was completed according to the work plan. Children were visited either at

parent’s house or at grandmothers house wherever they were available on due date.


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3.3.13. Assessment and monitoring

a) Assessment: The research Guide visited frequently few families to monitor the visits of

researcher for intervention and follow up.

b) Independent Observer – There may be a scope for selection bias during the process of

assessment of anthropometric outcomes as the investigator himself did the intervention and

ascertained the outcomes. Therefore, to address this issue an independent observer (not

connected with the study) has ascertained the outcomes measurements (anthropometry)

independently. Research guide randomly selected the subjects and assigned the job to collect

the measurements on the following day after the researcher collect the data. The

anthropometric measurements ascertained by the investigator and those ascertained by

independent observer were compared. It was found that there was strong agreement which

was statistically significant between the anthropometric measurements ascertained by

investigator and independent observer. (Appendix17)

3.3.14. Participation rate:

a) Intervention: Five mothers during 2nd

month, two mothers during 5th

month, one mother

during 11th

and one during 20th

month were not available for the educational intervention. A

total of 9 (3.2 %) visits were missed for intervention out of 280 visits for intervention.

b) Data collection: At different time points a total of 6 children (2 in intervention and 4 in

control) and their mother/caregivers were not available for data collection (6/690, 0.86 %).

All the children registered for the study were followed until they complete 2 years of age.

The missing data was not very significant amount so the missing data analysis was not done.


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3.3.15. Intention to treat: “Intention to treat” is a strategy for the analysis of randomized

controlled trials that compares patients in the groups to which they were originally randomly

assigned. This is generally interpreted as including all patients, regardless of whether they

actually satisfied the entry criteria, the treatment actually received, and subsequent withdrawal

or deviation from the protocol. We could not do the intention to treat analysis due to the

children who have lost for follow up have not been ascertained about outcome for the baseline

data. Therefore, we could not do the intention to treat analysis in our study177

.

3.3.16. Data analysis: The data analysis was done with the use of SPSS version 16.0. The

baseline characteristics, socio-demographic characteristics of the family were summarized

and presented in the form of percentages.

Anthropometric data and 24-hour recall diet consumption data at different time points

were summarized in the form of mean values and Standard Deviation (SD). The data were

analyzed with the Linear Mixed Model procedure to see the effect of intervention on weight,

length, chest circumference, head circumference and mid arm circumference compared with

control group children.

The dietary data was analyzed at National Institute of Nutrition –Hyderabad178

analyzed at NIN Statistics Lab. Researcher took the data to NIN and the analysis was done

with the help of the Statistician using the soft ware available in the institution.

The dietary energy, proteins, fat, cereals, pulses, milk and milk products from

complementary foods in intervention group compared with control group using repeated

measures for ANOVA.


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Feeding practices, hygienic practices, illness were presented in the form of

percentages and chi-square-test was performed to assess the statistical significance.

3.3.17. Instruments used in the study:

1) Health education module: A comprehensive health education module was developed to

educate the mothers on infant and young child feeding practices. The module was a guide to

conduct the counseling session. The module was converted as flipchart and used as tool to

educate the mothers. The pictorial flipchart was an effective instrument for delivering the

messages effectively. The pictorial calendar hanging on the wall in the house was

encouraging and an effective tool continuously. (Appendix 7, 8, 9, 10)

2) Proforma for socio – demographic characteristics: This instrument was developed to

obtain the background information of the subjects which include name, religion, caste, family

particulars, literacy status, occupation, type of family, income, environment and mode of

disposal of domestic waste. (Appendix 18)

3) Proforma to assess socio – economic status (Modified Udai–Pareek scale)175

: Socio-

economic Status of the family was assessed using the modified Udai Pareek scale. This scale

attempts to examine the socio-economic status for the rural or mixed population. The

Modified Udai Pareek scale consists of 10 items type of house, ownership of house, land

holding, vehicles owning, household belongings, possessing any livestock, social

participation of the family members, occupation, literacy status and any family member

working outside the country. The total score interpreted in terms of class was a maximum of

132 points. The rationale for selecting this tool is that the instrument can be used to assess the

family status especially in rural area. The socio – economic status was categorized into Low


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social class (0 to 39 points) Middle social class (40 to 69points) and High social class (more

than 70 points) based on composite score. (Appendix 19)

4) Proforma to assess baseline knowledge of mothers: This tool consisted of 15 items.

These items were meant to assess the baseline knowledge of mothers regarding the feeding

practices. The tool consisted of items on the basic feeding practices when to initiate

breastfeed, feeding colostrum, giving pre-lacteal feeds, positioning the baby to the breast,

exclusive breastfeeding, duration of breast feeding, feeding water, ideal age to start

complementary feeds, extra diet for lactating mother, knowledge about vaccines and family

diet168

. (Appendix 20)

5) New born proforma: The proforma was used to collect information on history of

consanguineous marriage, date of birth, sex of the child, birth order, number of antenatal

visits by mother, gestational age, place of delivery, mode of delivery, status of rooming in,

any education regarding breastfeeding in the hospital, any morbidity, immunization status,

and anthropometric measurements etc. (Appendix 21)

6) Proforma to assess feeding practices: This proforma was used to collect information on

current breastfeeding status, initiation of breastfeeding, positioning, feeding prelacteal feeds,

feeding colostrum, exclusive breastfeeding and duration of breastfeeding, time of initiation of

complementary foods, types of complementary foods, feeding during illness, hygienic

practices followed by mothers, developmental history, knowledge regarding the danger signs

morbidity conditions during the last 3 months, immunization history and anthropometric

measurements. Separate proforma was used at different time points to assess the feeding

practices of mothers at completion of 4, 6, 9, 12, 15, 18 and 24 months of age for the child.

Proper suckling will help the child to receive optimum benefit of breast feeding. Total 10


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signs were assessed through collecting the information from mothers and few observations

during breastfeeding the child. All the 10 signs were given equal weight age and assessed on a

10 point scale. Breastfeeding positioning was considered good when score was 7 or more.

(Appendix 22)

7. Proforma to assess hygienic practices: The hygienic practices were assessed interviewing

the mother/caregiver and observing the surrounding and home environment. Personal hygiene

includes practices such as mother washing hands before preparing hands, washing child’s

hands before eating food and after using toilet. The environmental sanitation includes items

such as clean and appropriate place for the child, kitchen floor is clean, and living room is

clean, no animal faces around the house. The hygienic practices followed by mothers were

assessed using a 15 item questionnaire. This was assessed on information collected from

mother and observations made during home visit. Assessment was done on a total 15-point

score179, 180

. (Appendix 22)

8) 24 - hour diet survey proforma: This tool was obtained from National Institute for

Nutrition, – Hyderabad. It was a 24-hour recall method tool and the researcher was trained in

the institute regarding collection of data. The tool consists of items such as type of food, the

ingredients in the preparation and quantity. The quantity of food consumed was measured

using the diet cups provided by National Institute of Nutrition. The data collection was

validated in the field. The Dietician from the Kasturba Hospital Manipal and the researcher

conducted 10 diet surveys in different age group of children. Both collected information from

the same family and the results were analyzed separately. The results showed there was 98%

similarity between the data collected. (Appendix 23)


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9) Anthropometric measurements: The anthropometric measurement of the newborn child

was obtained from the hospital records (inpatient record/discharge summary) and recorded

accordingly. Birth weight was recorded in grams, length was recorded in centimeters and the

head, chest and mid upper arm circumference was recorded in centimeters. Later during the

follow up visits researcher took the measurements using the standardized tools and

instruments. (Appendix 24)

a) Weight: Weight of the child was measured using a standardized digital weighing machine

(Citizen Company) with an acceptable error of 10 grams. Infant’s $ 6 months were made to

lie on the machine and children more than 6 months of age made to sit on the machine with

minimum cloth. The reading was recorded as the weight of the child. The weighing machine

was standardized by weighing a known measurement during every visit181

.

b) Crown heel length/height: The crown heel length was recorded using a portable

infantometer obtained from National Institute of Nutrition (NIN) – Hyderabad. The head was

held firmly in position against a fixed upright head board. Legs were straightened keeping feet

right angles to the head with toes upwards. A sliding foot board was brought into firm contact

with the child’s heels. Length of the baby was measured from a scale which was fixed into the

measured table. Children aged above one year and 18 months were made to stand with bare

foot on a flat floor against a wall with feet parallel and with heels, buttocks, shoulders and

back of the head touching the wall. The head was held comfortably erect and mark made on

the wall. Height is measured by using a measuring tape36

.

c) Head circumference – Head circumference was measured with arms relaxed and legs

apart. A measuring tape was passed over the occipital protuberance at the back, tightly so as

to compress the hair36, 181

.


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d) Chest circumference: The measuring tape was placed in a horizontal plane at the level of

the nipples, no compression is applied. Child held in standing position erect. Child arms was

initially raised to place the tape and then lowered. Maximum circumference is measure during

normal breathing36, 181

.

e) Mid Arm circumference: Mid upper arm, circumference was recorded midway between

tip of acromion process of scapula and olecranon. Process of Ulna the tape was passed around

the arm at the marked level and measurement was taken36

.

3.3.18. Procedures followed before administering the instruments

1) Content validity: The content validity of all the tools was established by administering the

tools to five experts (Proforma for socio-demographic characteristics, proforma to assess

socio-economic status, proforma to assess baseline knowledge of mothers, newborn proforma,

proforma to assess feeding practices and hygienic practices). To establish content validity the

tools were submitted to five experts. These experts were from the field of Pediatrics,

Community Medicine, Nursing, Communication sciences and Sociology. The selection of

experts was done based on their experience and clinical expertise. Validation was obtained in

terms of appropriateness and relevance of items in the tool. There was acceptable agreement

on all the items of the different perform used in our study. The suggestion was to modify few

questions. Modifications were done accordingly and the revised proforma was used for the

study.

2) Translation of the tools: After the content validation the tools were translated to Kannada

by a language expert. The Kannada version of the tool was then retranslated to English by

another language expert. There was no difference in sentence construction or language. Both

the versions were verified by the researcher.


P a g e | 156

3) Pretesting: The Kannada version of the tools were pretested on 5 mothers in each group

(pregnant women, mothers having children below 6 months, mothers having children 6 to 12

months, and mothers having children 1 to 2 years). Oral consent was obtained before the try

out. The tryout of the tool was done to determine the clarity of items, presence of ambiguous

items, time taken to complete the questionnaire, difficulty in understanding the scientific

terms, feasibility and acceptability. All the items were clear and understandable. The average

duration of administering the questionnaire was determined.

4) Pretesting and validating the instruments: The reliability was tested in two clinics. 10

children in different age group were measured for their anthropometric measurements. The

researcher measured the height, weight, head and chest circumference and mid arm

circumference of each child and noted down separately. An independent observer was

assigned the job to do the same when the mother leaving the clinic. The research guide took

all the measurements from both and analyzed to see the validity of researcher taking the

measurements. There was no significant difference between the two measurements. The

digital weighing machine was validated frequently with a known weight.

3.3.19. Procurement of tools

a) Weighing machine: Two digital weighing machines were bought for the study purpose.

An electronic digital weighing machine from Citizen Company with a minimum error of 10

grams was used to weigh the children.

b) Infantometer: In consultation with National Institute of Nutrition (NIN) Field Division an

acceptable type of infantometer was bought to use for the study. The recommended

infantometer had an acceptable error of 0.1 centimeters.


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c) Diet cups – National Institute of Nutrition is using a particular type of diet cups which are

validated and acceptable all over. One set (12 cups and 2 spoons) of standardized diet cups of

National Institute of Nutrition were used to measure the food consumed by the children in the

field for diet survey in the field. (Appendix 24)

3.3.20. Training to conduct diet survey:

Diet survey was one of the important part of the research study planned by the

researcher. It was decided to follow 24-hour recall method diet survey for the study. The field

Division from National Institute of Nutrition (NIN) was consulted regarding methodology of

dietary assessment. Researcher attended training in the institute for two days in the field. The

practical training was given to researcher on how to elicit the required information, how to

measure the ingredients, and how to record the measurements etc. The field staff verified the

diet sheets and corrections were made. Mistakes were corrected and finally the training officer

of the field division was satisfied about the data collected. This training was conducted in

pediatric nutrition unit of Niloufer Hospital, Hyderabad during 14 to 16 May 2006.

3.3.21. Infant and Young Child Feeding practices (IYCF) Training

Breast Feeding Network of India (BPNI) is conducting national level training on

“Infant and young child feeding counseling - A Training Course-The 3 in 1 Course (an

Integrated Course on Breastfeeding, Complementary Feeding and Infant Feeding & HIV-

Counseling) time to time. Researcher attended one of the training program held at

UCMS/GTB Hospital Delhi from 22nd

to 28th

January 2007 and certified as “IYCF

Counseling Specialist”. This training was very much helpful in imparting the intervention.

During December 2010 and January 2011 researcher took part in four Middle Level Trainers


P a g e | 158

Training program in Punjab as National Trainer. The training program was organized by

Department of Family Welfare, Punjab Stat Government and facilitated by BPNI. (Annexure

25)

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