Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Other: counselling

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

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Oromia
    • Jimma, Oromia, Ethiopia, 378
      • Jimma University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking	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.
No Intervention: control arm; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Madda walabu university
• Investigators: Study Director: Tefera Proff. Belachew, PHD, Dean of School of Graduate Studies, Jimma University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Anemia; Complementary feeding; Undernutrition; soaking Flours
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: MWU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No