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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)

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ClinicalTrials.gov Identifier: NCT02956941
Recruitment Status : Unknown
Verified November 2016 by Tsedeke Wolde, Jimma University.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Tsedeke Wolde, Jimma University

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.


Condition or disease Intervention/treatment Phase
Child Nutrition Disorders Behavioral: BCC on Essential Nutrition and Hygiene Actions (ENHAs) Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Intervention group will be received 12 months on nutrition behavior change communication using two modes (lecture, and posters).
Behavioral: BCC on Essential Nutrition and Hygiene Actions (ENHAs)
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.

No Intervention: Control cluster
Control group will receive routine dietary practices.



Primary Outcome Measures :
  1. Linear growth as assessed by mean change in height for age z score [ Time Frame: at 6 months (mid line) and at 12 months (end line) of the intervention ]
    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.



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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956941


Locations
Ethiopia
Jimma University Recruiting
Jimma, Oromia, Ethiopia, 378
Contact: Tsedeke Wolde Hailemariam, Master    +251910943069    tsedekewolde@yahoo.com   
Contact: Tefera Belachew Lema, PhD       teferabelachew@gmail.com   
Sub-Investigator: Tefera Belachew Lema, PhD         
Sponsors and Collaborators
Jimma University

Responsible Party: Tsedeke Wolde, Lecturer, Jimma University
ClinicalTrials.gov Identifier: NCT02956941     History of Changes
Other Study ID Numbers: 4088/08
4086/2016 ( Other Identifier: Jimma University )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It depends on the data quality and quantity.

Keywords provided by Tsedeke Wolde, Jimma University:
Academic performance
Behaviour change communication
Nutritional status
School children
Ethiopia

Additional relevant MeSH terms:
Nutrition Disorders
Child Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs