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Clinical Trials/NCT05254717
NCT05254717CompletedNot Applicable

Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration Level, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities of Children Age 6-24 Months

Madda walabu university1 site in 1 country700 target enrollmentStarted: November 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
700
Locations
1
Primary Endpoint
children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)

Study Overview

Brief 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.

Detailed 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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Months to 24 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Interventional arm

Experimental

Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking

Intervention: counselling (Other)

control arm

No Intervention

The control group will be monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention.

Outcomes

Primary Outcomes

children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)

Time Frame: 15 days post intervention

children's Episode of Diarrheal, cough and fever Morbidities

Time Frame: 15 days post intervention

children's blood hemoglobin concentration level

Time Frame: 15 days post intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Madda walabu university
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mekonnen Tegegne

Principal Investigator

Madda walabu university

Study Sites (1)

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