NCT02956941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
376

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

October 28, 2016

Last Update Submit

November 10, 2016

Conditions

Keywords

Academic performanceBehaviour change communicationNutritional statusSchool childrenEthiopia

Outcome Measures

Primary Outcomes (1)

  • 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.

    at 6 months (mid line) and at 12 months (end line) of the intervention

Study Arms (2)

BCC on Essential Nutrition and Hygiene Actions (ENHAs)

EXPERIMENTAL

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)

Control cluster

NO INTERVENTION

Control group will receive routine dietary practices.

Interventions

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.

BCC on Essential Nutrition and Hygiene Actions (ENHAs)

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 7, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations