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Child Nutrition DisordersEarly Phase 1BCCNCT02956941

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

A Early Phase 1 study testing BCC on Essential Nutrition and Hygiene Actions (ENHAs) in people with Child Nutrition Disorders, run by Jimma University at 1 site in Ethiopia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Child Nutrition Disorders
What is being tested?
BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
1 siteEthiopia
Study dates
Oct 2016to Apr 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site, 1 recruiting
  • Jimma University

    Jimma, Oromiya, 378

    Tsedeke Wolde Hailemariam, Master, +251910943069, tsedekewolde@yahoo.com

    Tefera Belachew Lema, PhD, teferabelachew@gmail.com

    Recruiting

Other trials in Ethiopia

About this study

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.

Read the 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.

Being tested
BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Keywords
Academic performance, Behaviour change communication, Nutritional status, School children, Ethiopia
Medical subject headings
Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCC on Essential Nutrition and Hygiene Actions (ENHAs)Behavioural

    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.

Study groups in NCT02956941
Study groupRoleWhat they receive
BCC on Essential Nutrition and Hygiene Actions (ENHAs)ExperimentalIntervention group will be received 12 months on nutrition behavior change communication using two modes (lecture, and posters).
Receives: Behavioral: BCC on Essential Nutrition and Hygiene Actions (ENHAs)
Control clusterNo interventionControl group will receive routine dietary practices.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJan 2017 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02956941
Sponsor's protocol ID
4088/08
Other IDs
4086/2016
Acronym
BCC
Status last verified
Nov 2016
First submitted
28 Oct 2016
Last updated
11 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: It depends on the data quality and quantity.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BCC on Essential Nutrition and Hygiene Actions (ENHAs) in people with Child Nutrition Disorders, run by Jimma University at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.

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