NCT04846062

Brief Summary

Hypotheses of the study

  1. 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. 2.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
  3. 3.Children's poor dietary intake has low hemoglobin concentration compared to their peers who used diversified dietary intake.
  4. 4.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.
  5. 5.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.
  6. 6.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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 8, 2021

Last Update Submit

April 12, 2021

Conditions

Keywords

Micronutrient, nutrition behavior, children growth, Highland Ethiopia

Outcome Measures

Primary Outcomes (4)

  • Knowledge and Attitude of children's mothers/caregivers about micronutrients utilization

    Dietary Diversity Score

    one to two months

  • Iodine concentration

    in micro gram per litter of urine

    one to two months

  • Hemoglobin concentration

    in mg per dl of blood

    one to two months

  • children growth

    Height in centimeter relevant to age computed for WHO Anthropometry

    one month to two months

Other Outcomes (4)

  • Knowledge and Attitude of children's mothers/caregivers about micronutrient utilization

    one to two months

  • Iodine concentration

    two to three weeks

  • Hemoglobin concentration

    one to three weeks

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: nutrition behavior intervention

control

ACTIVE COMPARATOR

Control arm will not receive nutrition behavior

Behavioral: nutrition behavior intervention

Interventions

Iodized salt utilization and iron dietary intake behavior

Interventioncontrol

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children with pair mothers

You may not qualify if:

  • children age less than 06 months and grater than 59 months,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
buffer zone will be set between control and intervention will masked with
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: nutrition Behavior intervention will be given for intervention arm (0) the control arm will not receive(1)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mister

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 15, 2021

Study Start

April 15, 2021

Primary Completion

September 10, 2021

Study Completion

December 30, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04