Infant Growth Clinical Trial
Official title:
Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth in Samfya District, Luapula Province, Zambia
The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes.
Stunting is an irreversible consequence of inadequate growth during the early life of a child
in the absence of appropriate interventions before the age of 2 years. Stunting affect 151
million (22.2%) of children worldwide. World Health Organisation (WHO) global nutrition
target for 2025 is to reduce the number of stunted children under-five years by 40%.3,4 The
first 1000 days (conception to 2years) is crucial for later development. It is also the
period when stunting prevalence is at its highest. In Zambia, the stunting prevalence is 40%8
, 43% in Luapula province with Samfya district statistics as high as 49%.
Good complementary feeding of children contributes to the positive characteristics of growth
trends observed in developed countries. It is a period of introducing solids and age of
accelerated growth. Improved linear growth in food insecure homes is achievable by using
locally available foods that are sustainable and usually acceptable. The role of fish's
contribution to child's optimal growth and development in the first 1 000 days in Zambia has
been reviewed. A food consumption survey also shows that fish is one of the highly consumed
protein foods in low-income households in Zambia.To the investigators knowledge, fish has not
been assessed as an early complementary food for infants aged 6 months in Zambia. This study
will investigate the effect of providing dry fish powder to 6 months old infants (over a 6
months period) on their linear growth Research Question Can the introduction of fish during
early complementary feeding improve infant linear growth in Samfya district, Zambia? Study
Aim The aim of this study is to determine if the introduction of fish during early
complementary feeding improves infant's linear growth outcomes.
Objectives Primary Objective The primary objective of the study is to evaluate the effect of
introducing fish during early complementary feeding on growth outcomes of infants in Samfya
district, Zambia.
Secondary Objectives
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine basic and underlying (socio-demographic, infants/maternal history) factors
associated with stunting, wasting and underweight in the study area
- To determine the prevalence of fish allergy in the study area
- To assess the acceptability of fish powder as an early complementary food.
Methodology
Samfya district is a rural area in North-East Zambia in Luapula Province and has 210, 251
inhabitants, of which 42, 050 (20%) are under-five children. The study will be conducted at
Shikamushile Rural Health Centre (RHC) in Samfya district. Shikamushi RHC is one of the 10
RHCs without any nutrition programme. It serves a population of 11, 800; 2400 (20%) of these
children attend the under-five clinic at the centre. This centre has more cases of
malnourished children referred to the hospital for treatment than any other RHC.
The study will be a single blinded randomised controlled trial. The trial will have two arms
with the intervention group receiving fish powder (Chisense) while the control will be given
a placebo in the form of sorghum powder. Infants aged 6 months will be followed up for a
period of 6 months until they are 12 months old. The total sample size estimate is 238
infants, 119 infants per group with the possible attrition rate of 20%, and power of 80% to
detect a 0.45 growth difference in length-for-age Z score between the intervention and
control group.
The investigator intends to use a questionnaire to collect socio-demographic data and take
anthropometric measurements (from both mothers and infants) at baseline to determine basic
and underlying factors associated with stunting, wasting and underweight in the study area.
The data set will include, mother's age, nutrition status, number of births, source of
drinking water, family size, source of income, breastfeeding and complementary food.
Anthropometric measurements will be used to determine the prevalence of stunting, wasting and
underweight in the study area. In addition, a 24-hour dietary recall questionnaire will be
administered to determine the type of food given to children. Furthermore, a skin prick test
will be conducted at baseline on infants aged 6 months to determine the prevalence of fish
allergy in the study area.
Infants will then be followed up for 6 months during which, infants in the intervention group
will receive 12g (7.6g protein) fish powder while the control will receive 7g (0.9g protein)
sorghum powder per day. The follow-up will include, weekly and monthly follow-up Weekly home
visits: During weekly home visits, the research assistants will distribute pre-packed
fish/sorghum powder to last a week to the intervention and control group respectively.
Research assistants will keep record of any morbidities experienced by the infants. Adherence
to the intervention will be assessed by reports from mothers of infants and empty fish powder
storage bowls.
Monthly RHC visits: Each month the mothers in both the intervention and control group will
have their infant's anthropometric (weight, length, head circumference and mid-upper aim
circumference) measurements taken during visits at the RHC. A 24-hour dietary recall will be
administered every two months to determine dietary intake of infants. After the intervention,
mothers of infants will be given a questionnaire to assess acceptability of fish as an early
complementary food. The questionnaire will have questions on the flavour, colour, and
consumption.
Statistical Analysis: Descriptive statistics will be used to describe the incidence of
allergy among the study infants. The relationships between continuous response variables and
nominal input variables, for example different diets, will be analysed using appropriate
ANOVA or pooled or Welch t-tests if the two groups are involved. Appropriate repeated
measures ANOVA will be used when responses are measured at specific time intervals. When only
two times are compared, this will be done with paired t-tests. The relation between nominal
variables will be investigated with contingency tables and appropriate chi-square tests, such
as the likelihood ratio chi-square test. A p-value of p < 0.05 will represent statistical
significance and 95% confidence intervals will be used to describe the estimation of unknown
parameters.
The study protocol has approval from the Health Research Ethics Committee (HREC) and Tropical
Disease Research Centre (TDRC), Ndola Zambia. . Permission to conduct the study at
Sikamushile rural health center was sought from Samfya District Medical Office (SDMO). The
following was ensured, informed consents, freedom of participation/withdrawal, and anonymity.
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