Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth
Condition: Infant Growth
Study type: Interventional

Summary: 
      The aim of the study is to provide proof that giving fish during early complementary feeding
      improves infant linear growth outcomes.
    

Detailed description: 
      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.
    

Intervention name(s): Fish Powder; Sorghum powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dry small fish (Chisense) is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.; Dry sorghum is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An independent statistician not be part of the study prepared the randomisation schedule. All eligible infants were randomly assigned to either the intervention (Chisense fish powder) or the control (placebo in the form of sorghum powder) group at 6 months. A 1:1 ratio using a computerised random number generator and block randomisation in Microsoft Excel was used to randomise the infants to two groups of equal size. The schedule was stratified by the gender of infants (boy or girl) to enable gender balance in both groups. Allocation of concealment was done using a central randomisation service through a computer algorithm to protect the randomisation schedule. If there two infants from the same household or in case of twins, they were treated as a single baby during randomisation to avoid contamination. However, each child had his or her own code and will be assessed as an individual throughout the study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infants; Growth; Stunting; Fish; Intervention