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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05254717
Other study ID # MWU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 15, 2022

Study information

Verified date September 2022
Source Madda walabu university
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Therefore, the aim of this study is to determine effect of soaking complementary foods on hemoglobin, nutritional and health status of children 6-23 months in agrarian community of bale zone.


Description:

Objectives of the intervention - To determine prevalence and associated factors of nutritional status and anemia among children aged 6-23 months in agrarian community of Bale zone - To Explore the complementary feeding practice knowledge perception of mother with children aged 6-23 months in agrarian community of Bale zone - To determine effect of soaking complementary foods flour on nutritional status of children aged 6-23 months in agrarian community of Bale Zone - To determine effect of soaking complementary foods flour on hemoglobin level of children aged 6-23 months in agrarian community of Bale Zone - To determine effect of soaking complementary foods flour on frequency of morbidity of children aged 6-23 months in agrarian community of Bale Zone Target groups The target groups for the intervention will be mothers with their children aged 6-23 months in selected Districts of Bale zone and participated in the baseline study. Following baseline study, the two districts were assigned to be either an intervention or comparison group randomly. While the intervention community received the Nutrition counselling on promotion of complementary flour soaking, the comparison community was monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention in the target. The intervention will be carried out for a period of six months. End-line data collection included the following major components: - Dietary Diversity practice - Anthropometric measurements - Hemoglobin test


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date May 15, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 24 Months
Eligibility Inclusion Criteria: - Voluntarily agreed mothers with children aged 6-23 month - Mothers with children aged 6-23 month who lived at least six months in the selected communities - Mothers who have no plan to leave the area within 6 months period Exclusion Criteria: - • If the child is seriously ill at the time of data collection - Children with severe anemia hemoglobin level <= 7mg/dl will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
counselling
intervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours.

Locations

Country Name City State
Ethiopia Jimma University Jimma Oromia

Sponsors (1)

Lead Sponsor Collaborator
Madda walabu university

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary children's blood hemoglobin concentration level 15 days post intervention
Primary children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age) 15 days post intervention
Primary children's Episode of Diarrheal, cough and fever Morbidities 15 days post intervention
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