Unrecognized ConditionNCT04846062
Nutrition Behavior on Micronutrient Among Growth Children in Central Highland of Ethiopia: Cluster Randomized Trial.
A study testing nutrition behavior intervention in people with Unrecognized Condition, run by Jimma University.
Trial summary
Hypotheses of the study 1. Mothers/ caregivers who have less knowledge and attitude about the prevention of IDD their table salt obtained from in the households has less quantity of iodide than those mothers/ caregivers who might have knowledge and attitude. 2. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- nutrition behavior intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2021to 30 Dec 2021
- Phase
- Interventional
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children with pair mothers
Who cannot join
- children age less than 06 months and grater than 59 months,
About this study
Official title: Nutrition Behavioral Change on Iron and Iodine Concentration Among Growth of Children Age 6 to 59 Months in Central Highland of Ethiopia: Cluster Randomized Trial.
Hypotheses of the study
- Mothers/ caregivers who have less knowledge and attitude about the prevention of IDD their table salt obtained from in the households has less quantity of iodide than those mothers/ caregivers who might have knowledge and attitude.
- Mothers/ caregivers with poor knowledge and attitude in iodized salt utilization circumstances that their index children have at higher risk of iodine deficiency compared with their properly utilizes counterparts. linear
- Children's poor dietary intake has low hemoglobin concentration compared to their peers who used diversified dietary intake.
- Children with a low concentration of iodine have stunted growth (linear growth) compared with their high iodine concentration peers at the end of the follow-up period of fifteen months.
- Children with a low concentration of hemoglobin have stunted growth (linear growth) compared with their high hemoglobin concentration peers at the end of the follow-up fifteen months.
- Higher concentrations of micronutrients due affect the growth of children compared with their higher concentration of micronutrients at the end of the follow-up period of fifteen months.
Read the detailed description
Objective: The aim of this study is to determine effect of BCC on micronutrients intake and growth of children age 6-59 month old in Arsi Zone highland, Oromiya, Ethiopia.
Chapter 1 knowledge and attitude about the prevention of iodine deficiency disorders among women and quantification of iodine found in table salt. This chapter presents the investigation of iodine content in table salts samples obtained from households and headquarters markets and the women's understanding and approach status about iodine deficiency disorders.
Chapter 2 Median urinary iodine concentration and associated factors among children age 6 to 59 months; It summarizes the median level of iodide found in children's urine and determined significant associated factors.
Chapter 3 hemoglobin level and associated factors among children age 6 to 59 months. It describes predictors of knowledge and attitude about the prevention of iron deficiency anemia among women and it presents the hemoglobin threshold of children and determines factors.
Chapter 4 effect of NBC on iodised salt utilization and median urine iodine concentration among the growth of children. This chapter describes the impact of NBC intervention on iodised salt utilization in the HH, compaction of the endine - baseline difference of median urine concentration, and its significant association with the growth of children.
Chapter 5 effect of NBC on prevent anemia and hemoglobin concentration among the growth of children. This chapter describes the impact of NBC on iron-rich dietary intake in the HH. Also, the chapter described the comparition of endine - baseline mean differences of hemoglobin concentration, and factors associated with the growth of children.
Chapter 6 micronutrient concentration effects on growth defect among children; this chapter describes the deference endline - baseline difference of the mean differences in iron and iodine and concentration association with linear growth of children.
Methods: Community based, clustered randomized controlled trial will be carried out.
Study sample size: The sample size was determined using Gpower 3.0 software assuming a power of 95%, precision of 5%, and an effect size of 0.25 giving 834. Additionally, we considered the loss of study participants due to an increase in age of children above 59 months for the given intervention period was 11% =95. Where the design effect had 10% =83 and a final the estimated sample size was 1012.
Multistage sampling method was applied to select 16 kebeles [lower administration Units] randomly and equally assigned into intervention and control clusters using computer ENA 2011 version software. Further, systematic random sampling will be used to select mothers/caregivers with their children from randomly assigned kebeles Baseline data will be collected from recruited mothers and from their pair children. Questionnaire on behaviours on dietary intake of children and micronutrients utilization, and anthropometric data will be collected; Households' table salt samples will be collected and analyzed with a titration biomarker in Ethiopian Public health institute food and nutrition laboratory (EPI). Urine samples for baseline will be collected and transported to EPI and analyzed to determine urine iodine Concentration (UIC) and this will be applicable at the end line of nutrition behavior change intervention. Blood samples will be collected to determine hemoglobin level before after nutrition behavior change intervention implementation.
Data processing and analysis: Anthropometric and other data were entered into EpiData 3.0 version software and transferred and analyzed using the Statistical Package for Social Science statistical software for Windows, version 21, Anthropometric data will be exported to Emergency Nutrition Assessment [ENA] software to generate height for age Z-score (HAZ) and weight for height z-score [WHZ]. HAZ ≥ -2 Z-score will be categorized as normal growth status and HFA < -2 z-score will be indicated as a growth defect. According to WHO classification, > 40% is very high and 30 to 39% is high and 20 to 29 medium and < 20% is low (22). Also, weight for height Z score (WHZ) was generated to determine wasting among children (16, 17). Anthropometric results of children's growth at baseline and end-line surveys were compared with the WHO 2005 growth standard using ENA software.
Linear regression was used to determine the effect of iron and iodine concentration on the linear growth of children. Independent sample t test will be used to determine mean differences between end-line-baseline in micronutrient concentrations (iodine and iron) and will be compared between intervention and control groups and significance will be determined with Standard Error (P<0.05) . Finally, independent variables that will have P <0.25 in samples t-test will be transferred to Generalized Estimating Equations [GEE] for further analysis and the results presented using Beta coefficients (β) and 95% confidence intervals.
- Conditions
- Unrecognized Condition
- Being tested
- nutrition behavior intervention
- Keywords
- Micronutrient, nutrition behavior, children growth, Highland Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition behavior interventionBehavioural
Iodized salt utilization and iron dietary intake behavior
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intervention arm will receive nutrition behavior Children's mothers/caregivers will receive explanatory education and behavior about micronutrient essentiality and utilization. Also, dietary diversification and demonstration in the process of enriching child complimentary food will be given for participants every month for the consecutive six months. Posters and video shows will be used. Receives: Behavioral: nutrition behavior intervention |
| control | Active comparator | Control arm will not receive nutrition behavior Receives: Behavioral: nutrition behavior intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and Attitude of children's mothers/caregivers about micronutrients utilization
Dietary Diversity Score
Measured: one to two months
Iodine concentration
in micro gram per litter of urine
Measured: one to two months
Hemoglobin concentration
in mg per dl of blood
Measured: one to two months
children growth
Height in centimeter relevant to age computed for WHO Anthropometry
Measured: one month to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion10 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- nutrition Behavior intervention will be given for intervention arm (0) the control arm will not receive(1)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,012 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Addis Ababa University
- Responsible party
- Principal investigator, Abebe Ferede, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846062
- Sponsor's protocol ID
- IHRPGD/3007/18
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Behavioral Change on Iron and Iodine Concentration Among Growth of Children Age 6 to 59 Months in Central Highland of Ethiopia: Cluster Randomized Trial.
- ClinicalTrials.gov ID
- NCT04846062
- Acronym / sponsor ID
- IHRPGD/3007/18
- Conditions
- Unrecognized Condition
- Keywords
- Micronutrient, nutrition behavior, children growth, Highland Ethiopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,012 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- University of New Mexico, Addis Ababa University
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Apr 2021 (actual)
- 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.
Hypotheses of the study
- Mothers/ caregivers who have less knowledge and attitude about the prevention of IDD their table salt obtained from in the households has less quantity of iodide than those mothers/ caregivers who might have knowledge and attitude.
- Mothers/ caregivers with poor knowledge and attitude in iodized salt utilization circumstances that their index children have at higher risk of iodine deficiency compared with their properly utilizes counterparts. linear
- Children's poor dietary intake has low hemoglobin concentration compared to their peers who used diversified dietary intake.
- Children with a low concentration of iodine have stunted growth (linear growth) compared with their high iodine concentration peers at the end of the follow-up period of fifteen months.
- Children with a low concentration of hemoglobin have stunted growth (linear growth) compared with their high hemoglobin concentration peers at the end of the follow-up fifteen months.
- Higher concentrations of micronutrients due affect the growth of children compared with their higher concentration of micronutrients at the end of the follow-up period of fifteen months.
Detailed description
Objective: The aim of this study is to determine effect of BCC on micronutrients intake and growth of children age 6-59 month old in Arsi Zone highland, Oromiya, Ethiopia.
Chapter 1 knowledge and attitude about the prevention of iodine deficiency disorders among women and quantification of iodine found in table salt. This chapter presents the investigation of iodine content in table salts samples obtained from households and headquarters markets and the women's understanding and approach status about iodine deficiency disorders.
Chapter 2 Median urinary iodine concentration and associated factors among children age 6 to 59 months; It summarizes the median level of iodide found in children's urine and determined significant associated factors.
Chapter 3 hemoglobin level and associated factors among children age 6 to 59 months. It describes predictors of knowledge and attitude about the prevention of iron deficiency anemia among women and it presents the hemoglobin threshold of children and determines factors.
Chapter 4 effect of NBC on iodised salt utilization and median urine iodine concentration among the growth of children. This chapter describes the impact of NBC intervention on iodised salt utilization in the HH, compaction of the endine - baseline difference of median urine concentration, and its significant association with the growth of children.
Chapter 5 effect of NBC on prevent anemia and hemoglobin concentration among the growth of children. This chapter describes the impact of NBC on iron-rich dietary intake in the HH. Also, the chapter described the comparition of endine - baseline mean differences of hemoglobin concentration, and factors associated with the growth of children.
Chapter 6 micronutrient concentration effects on growth defect among children; this chapter describes the deference endline - baseline difference of the mean differences in iron and iodine and concentration association with linear growth of children.
Methods: Community based, clustered randomized controlled trial will be carried out.
Study sample size: The sample size was determined using Gpower 3.0 software assuming a power of 95%, precision of 5%, and an effect size of 0.25 giving 834. Additionally, we considered the loss of study participants due to an increase in age of children above 59 months for the given intervention period was 11% =95. Where the design effect had 10% =83 and a final the estimated sample size was 1012.
Multistage sampling method was applied to select 16 kebeles [lower administration Units] randomly and equally assigned into intervention and control clusters using computer ENA 2011 version software. Further, systematic random sampling will be used to select mothers/caregivers with their children from randomly assigned kebeles Baseline data will be collected from recruited mothers and from their pair children. Questionnaire on behaviours on dietary intake of children and micronutrients utilization, and anthropometric data will be collected; Households' table salt samples will be collected and analyzed with a titration biomarker in Ethiopian Public health institute food and nutrition laboratory (EPI). Urine samples for baseline will be collected and transported to EPI and analyzed to determine urine iodine Concentration (UIC) and this will be applicable at the end line of nutrition behavior change intervention. Blood samples will be collected to determine hemoglobin level before after nutrition behavior change intervention implementation.
Data processing and analysis: Anthropometric and other data were entered into EpiData 3.0 version software and transferred and analyzed using the Statistical Package for Social Science statistical software for Windows, version 21, Anthropometric data will be exported to Emergency Nutrition Assessment [ENA] software to generate height for age Z-score (HAZ) and weight for height z-score [WHZ]. HAZ ≥ -2 Z-score will be categorized as normal growth status and HFA < -2 z-score will be indicated as a growth defect. According to WHO classification, > 40% is very high and 30 to 39% is high and 20 to 29 medium and < 20% is low (22). Also, weight for height Z score (WHZ) was generated to determine wasting among children (16, 17). Anthropometric results of children's growth at baseline and end-line surveys were compared with the WHO 2005 growth standard using ENA software.
Linear regression was used to determine the effect of iron and iodine concentration on the linear growth of children. Independent sample t test will be used to determine mean differences between end-line-baseline in micronutrient concentrations (iodine and iron) and will be compared between intervention and control groups and significance will be determined with Standard Error (P<0.05) . Finally, independent variables that will have P <0.25 in samples t-test will be transferred to Generalized Estimating Equations [GEE] for further analysis and the results presented using Beta coefficients (β) and 95% confidence intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- nutrition Behavior intervention will be given for intervention arm (0) the control arm will not receive(1)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: nutrition behavior interventionIntervention arm will receive nutrition behavior Children's mothers/caregivers will receive explanatory education and behavior about micronutrient essentiality and utilization. Also, dietary diversification and demonstration in the process of enriching child complimentary food will be given for participants every month for the consecutive six months. Posters and video shows will be used. |
| control | Active comparator | Behavioral: nutrition behavior interventionControl arm will not receive nutrition behavior |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children with pair mothers
Key exclusion criteria (1 listed)
- children age less than 06 months and grater than 59 months,
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 |
|---|---|---|
| nutrition behavior interventionIodized salt utilization and iron dietary intake behavior | Behavioural | Intervention, control |
Primary outcome
Knowledge and Attitude of children's mothers/caregivers about micronutrients utilization
Time frame: one to two months
Dietary Diversity Score
Iodine concentration
Time frame: one to two months
in micro gram per litter of urine
Hemoglobin concentration
Time frame: one to two months
in mg per dl of blood
children growth
Time frame: one month to two months
Height in centimeter relevant to age computed for WHO Anthropometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition behavior intervention in people with Unrecognized Condition, run by Jimma University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and Attitude of children's mothers/caregivers about micronutrients utilization (time frame: one to two months). The study lists 4 primary outcomes in all. 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 15 Apr 2021.