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Effect of Behavior Change Communication About Improved Micronutrient Intake on Nutritional Status and Academic Performance of School Age Children in Meskan District, Gurage Zone, South Ethiopia (BCC)

Primary Purpose

Child Nutrition Disorders

Status
Unknown status
Phase
Early Phase 1
Locations
Ethiopia
Study Type
Interventional
Intervention
BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Sponsored by
Jimma University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Nutrition Disorders focused on measuring Academic performance, Behaviour change communication, Nutritional status, School children, Ethiopia

Eligibility Criteria

10 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Participant inclusion criteria:

  • All consenting students of classes in all clusters will be recruited for the study.

Participant exclusion criteria:

  • School directors and students who are not able to provide informed consent will be ineligible to take part in the trial.

Sites / Locations

  • Jimma UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BCC on Essential Nutrition and Hygiene Actions (ENHAs)

Control cluster

Arm Description

Intervention group will be received 12 months on nutrition behavior change communication using two modes (lecture, and posters).

Control group will receive routine dietary practices.

Outcomes

Primary Outcome Measures

Linear growth as assessed by mean change in height for age z score
The primary outcome of the study will be linear growth (stunting) as assessed by mean change in height for age z score at 10-15 years of age.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2016
Last Updated
November 10, 2016
Sponsor
Jimma University
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1. Study Identification

Unique Protocol Identification Number
NCT02956941
Brief Title
Effect of Behavior Change Communication About Improved Micronutrient Intake on Nutritional Status and Academic Performance of School Age Children in Meskan District, Gurage Zone, South Ethiopia
Acronym
BCC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jimma University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Nutrition Disorders
Keywords
Academic performance, Behaviour change communication, Nutritional status, School children, Ethiopia

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Arm Type
Experimental
Arm Description
Intervention group will be received 12 months on nutrition behavior change communication using two modes (lecture, and posters).
Arm Title
Control cluster
Arm Type
No Intervention
Arm Description
Control group will receive routine dietary practices.
Intervention Type
Behavioral
Intervention Name(s)
BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Intervention Description
The behavioral change communication (BCC) on micronutrient intake messages will be implemented based on Essential Nutrition and Hygiene Actions (ENHAs) on micronutrient deficiencies prevention and control. BCC intervention training workshop will be given to science teachers by principal investigator/ senior health professional in local language. Interventions will be delivered to students by their science teachers under the supervision of principal investigator/ school director for the consecutive three times.
Primary Outcome Measure Information:
Title
Linear growth as assessed by mean change in height for age z score
Description
The primary outcome of the study will be linear growth (stunting) as assessed by mean change in height for age z score at 10-15 years of age.
Time Frame
at 6 months (mid line) and at 12 months (end line) of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participant inclusion criteria: All consenting students of classes in all clusters will be recruited for the study. Participant exclusion criteria: School directors and students who are not able to provide informed consent will be ineligible to take part in the trial.
Facility Information:
Facility Name
Jimma University
City
Jimma
State/Province
Oromia
ZIP/Postal Code
378
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsedeke Wolde Hailemariam, Master
Phone
+251910943069
Email
tsedekewolde@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tefera Belachew Lema, PhD
Email
teferabelachew@gmail.com
First Name & Middle Initial & Last Name & Degree
Tefera Belachew Lema, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It depends on the data quality and quantity.

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Effect of Behavior Change Communication About Improved Micronutrient Intake on Nutritional Status and Academic Performance of School Age Children in Meskan District, Gurage Zone, South Ethiopia

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