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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Jimma University
Jimma, Oromiya, 378
Tsedeke Wolde Hailemariam, Master, +251910943069, tsedekewolde@yahoo.com
Tefera Belachew Lema, PhD, teferabelachew@gmail.com
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.
- Conditions
- Child Nutrition Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: BCC on Essential Nutrition and Hygiene Actions (ENHAs) |
| Control cluster | No intervention | Control group will receive routine dietary practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted7 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsedeke Wolde, Jimma University
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02956941
- Acronym / sponsor ID
- BCC / 4088/08
- Conditions
- Child Nutrition Disorders
- Keywords
- Academic performance, Behaviour change communication, Nutritional status, School children, Ethiopia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCC on Essential Nutrition and Hygiene Actions (ENHAs) | Experimental | Behavioral: 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). |
| Control cluster | No intervention | –Control group will receive routine dietary practices. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | BCC on Essential Nutrition and Hygiene Actions (ENHAs) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: Undecided. It depends on the data quality and quantity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.