Child Nutrition Disorders Clinical Trial
A cluster randomized controlled trial was chosen to exploit the robustness of this design to
help ascertain the efficacy of the BCC intervention compared to the routine dietary
practice. This protocol was developed according to the guidelines of the Consolidated
Standards of Reporting Trials (CONSORT) statement extension for cluster randomized trials.
The present study is aims to evaluate the effect of improving micronutrient intake through
behavior change communication intervention on nutritional status and academic performance of
school age children. Moreover, it may help to prevent or mitigate malnutrition. However to
the best knowledge of the authors, BCC intervention using posters, and lecture for school
teachers and students have not yet been empirically tested generally in Ethiopia,
specifically in the study area context. The present intervention is unique in combining the
use of conventional BCC intervention tools, that is, lecture and posters as reminder for
intervention reinforcement.
Background: School age children (SAC) are vulnerable to malnutrition which can have adverse
effects on their academic performance at school. Micronutrient deficiency affects as many as
two billion people in the world. About 250 million people out of this suffer from
deficiencies of iron, vitamin A, zinc and iodine are children. Malnutrition or micronutrient
deficiencies lead to lower enrolment and completion rates. A nutrition behavior change
strategy provides individuals with the necessary resources, knowledge, skills, motivation
and reinforcement needed to encourage positive change in health behavior. So far, there are
no any studies in the context of the study area in particular and in the country in general
on the effect of behavior change communication (BCC) on improving the nutritional status,
micronutrient intake and academic performance of school age children.
Objective: The aim of this study protocol is to evaluate the effects of the behavior change
communication (BCC) on nutritional status and academic performance of school age children in
South Ethiopia. The hypotheses are that the children in the intervention arm will increase
their academic performance and improve their nutritional status and micronutrient intake
more than the children in the control arm.
Methods: A cluster randomized controlled trial will be carried out to achieve the above
mentioned objectives, so that the findings will be used as an input for policies and
strategies that will be designed to mitigate the problem. A twelve-month cluster randomized
control trial will be conducted in 8 schools of 370 students with ten to fifteen years old.
The school intervention will be included BCC for students and science teachers on essential
nutrition and hygiene actions (ENHAs) will be provided by background of Health education
with Nutritionist. Demographic characteristics, knowledge, attitude & practices (KAP) of
micronutrient deficiencies prevention, micronutrient intake, anthropometric measurements
(height & weight), and academic performance assessment will be during baseline, mid line and
end line assessment. The academic performance of children will be assessed by using end term
semester results obtain for English and Mathematics subjects and for the overall subject
average.
The trial (n= 376) have two randomly assigned arms: a control cluster schools (CC) and
intervention cluster schools (IC) according to their cluster. The IC will be received 12
months on nutrition behavior change communication intervention using two modes (lecture, and
posters) while CC receive routine dietary practices. The primary outcomes of this study are
stunting, micronutrient intake, dietary diversity score, and academic performance of the
children; assess using questionnaires, KAP of micronutrient deficiencies prevention, and
anthropometry measurements. Secondary outcomes include thinness, underweight, overweight and
obesity.
A multivariate logistic regression analysis will be used to identify independent predictors
of nutritional status and academic performance of school age children after controlling for
confounding variables. The effect of BCC on nutritional status and academic performance will
be determined using generalized estimating equations (GEE) and or linear mixed effects
models.
For each of the primary outcomes, stunting, micronutrient intake, dietary diversity score,
and academic performance of children, the difference in mean change at follow-up between
intervention and control arms will be compared. The hypotheses will be tested under the
intent-to-treat principle using Generalized Linear Mixed Models (GLMMs) that will account
for the correlation induced by the clustering of children within schools. To further explore
the effect of the intervention, GLMMs will be fit that (1) adjust for baseline covariates of
interest, consider a priori, relevant to change in nutritional status, KAP of micronutrient
deficiencies prevention, micronutrient intake and dietary diversity score; (2) adjust for
baseline variables distribute differently between intervention groups; (3) test interaction
terms between treatment group and other covariates; and (4) examine completers only.
Differences in the secondary outcomes, underweight and obesity will be analyzed in a
parallel fashion. Mediating and moderating effects of the factors mentioned above will also
be explored.
Discussion: Results of the trial will provide evidence of the effectiveness of the nutrition
BCC innovation in school settings of Meskan district. They will provide recommendations for
strengthening the nutrition component of behavior change communication in child health
services.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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