Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
counselling
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Complementary feeding, soaking Flours, Undernutrition, Anemia
Eligibility Criteria
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
Sites / Locations
- Jimma University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional arm
control arm
Arm Description
Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking
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 Outcome Measures
children's blood hemoglobin concentration level
children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)
children's Episode of Diarrheal, cough and fever Morbidities
Secondary Outcome Measures
Full Information
NCT ID
NCT05254717
First Posted
February 2, 2022
Last Updated
September 13, 2022
Sponsor
Madda walabu university
1. Study Identification
Unique Protocol Identification Number
NCT05254717
Brief Title
Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Madda walabu university
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
Dietary Diversity practice
Anthropometric measurements
Hemoglobin test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Complementary feeding, soaking Flours, Undernutrition, Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking
Arm Title
control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
counselling
Intervention Description
intervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours.
Primary Outcome Measure Information:
Title
children's blood hemoglobin concentration level
Time Frame
15 days post intervention
Title
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
Title
children's Episode of Diarrheal, cough and fever Morbidities
Time Frame
15 days post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tefera Proff. Belachew, PHD
Organizational Affiliation
Dean of School of Graduate Studies, Jimma University
Official's Role
Study Director
Facility Information:
Facility Name
Jimma University
City
Jimma
State/Province
Oromia
ZIP/Postal Code
378
Country
Ethiopia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities
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